lista me cmimet e barnave jo te rimbursueshme 2014 , 17feb2014

340
1 LISTA ME ÇMIMET CIF DHE EXW TE BARNAVE TE REGJISTRUARA NE REPUBLIKEN E SHQIPERISE PER VITIN 2014 (JO TE RIMBURSUESHME) ME NEGOCIM Nr. Emri tregtar Forme-doza P.aktiv Paketimi Mbajtesi i Autorizimit te Tregtimit Fabrikuesi U.regjistrimi LEK USD EUR 1 GRODUREX Tablets x (5mg + 50mg) AMILORIDE HYDROCHLORIDE ANHYDROUS + HYDROCHLOROTHIAZIDE Box x 20 DR. GROSSMANN AG PHARMACA - ZVICER DR. GROSSMANN AG PHARMACA - ZVICER RIREGJ. 235/07.06.2011 2.2 2 GROFENAC Solution for injection x 75mg/3ml DICLOFENAC SODIUM Box x 5 ampoules x 3ml DR. GROSSMANN AG PHARMACA - ZVICER DR. GROSSMANN AG PHARMACA - ZVICER, HAUPT PHARMAWULFING GMBH - GJERMANI RIREGJ. 332/29.08.2011 2.5 3 GROFENAC 100 RETARD Retard Film Coated Tablets x 100 mg DICLOFENAC SODIUM Box x 10 DR. GROSSMANN AG PHARMACA - ZVICER DR. GROSSMANN AG PHARMACA - ZVICER REGJ. 42/28.01.2009 3 4 GROFENAC Emulsion Gel x 10 mg/1 g DICLOFENAC SODIUM Box x 1 Tube x 50 g DR. GROSSMANN AG PHARMACA - ZVICER DR. G. STREULI & CO. AG - ZVICER REGJ. 42/28.01.2009 2.25 5 GROFENAC Suppositories x 100 mg DICLOFENAC SODIUM Box x 5 DR. GROSSMANN AG PHARMACA - ZVICER MEDENA AG - ZVICER, WULFING PHARMA GMBH - GJERMANI, DR. GROSSMANN AG PHARMACA - ZVICER REGJ. 42/28.01.2009 3 6 RINGER MONICO Solution for infusion x (8.6g + 0.3g + 0.3g)/1000ml SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE 1 Glass bottle x 500ml MONICO SPA - ITALI MONICO SPA - ITALI REGJ. 433/17.09.2012 0.7 7 LACTATED RINGER'S INJECTION/VIOSE R Solution for infusion x (6g + 0.3g + 0.2g + 6.2g)/1000ml SODIUM CHLORIDE + POTASSIUM CHLORIDE + CALCIUM CHLORIDE DIHYDRATE + SODIUM LACTATE SOLUTION 50% Box x 10 plastic bottle x 500ml VIOSER SA - GREQI VIOSER SA - GREQI REGJ. 297/25.06.2012 6.8 Page 1

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Page 1: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

1

LISTA ME ÇMIMET CIF DHE EXW TE BARNAVE TE REGJISTRUARA NE REPUBLIKEN E SHQIPERISE PER VITIN 2014

(JO TE RIMBURSUESHME) ME NEGOCIM

Nr. Emri tregtar Forme-doza P.aktiv Paketimi

Mbajtesi i

Autorizimit te

Tregtimit Fabrikuesi U.regjistrimi LEK USD EUR

1

GRODUREXTablets x (5mg +

50mg)

AMILORIDE

HYDROCHLORIDE

ANHYDROUS +

HYDROCHLOROTHIAZIDE

Box x 20DR. GROSSMANN AG

PHARMACA - ZVICER

DR. GROSSMANN AG

PHARMACA - ZVICER

RIREGJ.

235/07.06.2011

2.2

2

GROFENAC

Solution for

injection x

75mg/3ml

DICLOFENAC SODIUMBox x 5

ampoules x 3ml

DR. GROSSMANN AG

PHARMACA - ZVICER

DR. GROSSMANN AG

PHARMACA - ZVICER,

HAUPT PHARMAWULFING

GMBH - GJERMANI

RIREGJ.

332/29.08.2011

2.5

3

GROFENAC 100

RETARD

Retard Film Coated

Tablets x 100 mg DICLOFENAC SODIUM Box x 10

DR. GROSSMANN AG

PHARMACA - ZVICER

DR. GROSSMANN AG

PHARMACA - ZVICERREGJ. 42/28.01.2009

3

4

GROFENACEmulsion Gel x 10

mg/1 g DICLOFENAC SODIUM

Box x 1 Tube x

50 g

DR. GROSSMANN AG

PHARMACA - ZVICER

DR. G. STREULI & CO. AG -

ZVICERREGJ. 42/28.01.2009

2.25

5

GROFENACSuppositories x

100 mgDICLOFENAC SODIUM Box x 5

DR. GROSSMANN AG

PHARMACA - ZVICER

MEDENA AG - ZVICER,

WULFING PHARMA GMBH -

GJERMANI, DR.

GROSSMANN AG

PHARMACA - ZVICER

REGJ. 42/28.01.2009

3

6

RINGER MONICO

Solution for

infusion x (8.6g +

0.3g +

0.3g)/1000ml

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

1 Glass bottle x

500mlMONICO SPA - ITALI MONICO SPA - ITALI

REGJ.

433/17.09.2012

0.7

7

LACTATED

RINGER'S

INJECTION/VIOSE

R

Solution for

infusion x (6g +

0.3g + 0.2g +

6.2g)/1000ml

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE + SODIUM

LACTATE SOLUTION 50%

Box x 10 plastic

bottle x 500mlVIOSER SA - GREQI VIOSER SA - GREQI

REGJ.

297/25.06.2012

6.8

Page 1

Page 2: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

2

8

SODIUM

CHLORIDE/VIOSE

R

Solution for

infusion x 0.9%

(w/v)

SODIUM CHLORIDE Box x 10 plastic

bottle x 500ml VIOSER SA - GREQI VIOSER SA - GREQI

REGJ.

297/25.06.2012;

VARIACION nr.844/1,

dt.12.02.20136.6

9

DEXTROSE/VIOSE

R

Solution for

infusion x 5% (w/v)

DEXTROSE ANHYDROUS

(as DEXTROSE (GLUCOSE)

MONOHYDRATE X

5.5G/100ML)

Box x 10 plastic

bottle x 500mlVIOSER SA - GREQI VIOSER SA - GREQI

REGJ.

297/25.06.2012

7.1

10

APRANAX PLUSFilm-coated tablets

x (550mg + 30mg)

NAPROXEN SODIUM +

CODEIN PHOSPHATE

HEMIHYDRATE

Box x 20"ABDI IBRAHIM ILAC SAN.

VE TIC. A.S." TURQI

"ABDI IBRAHIM ILAC SAN. VE

TIC. A.S." TURQIRegj.422/11.07.2013

4

11

BARCA

Prolonged release

film coated tablets

x 600mg

ETODOLAC MICRONISED Box x 10ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

140/19.03.2013

6

12

CEFUROXIME

ACTAVIS

Powder for solution

for I.M./I.V.

injection x

750mg/unit

CEFUROXIME (AS

CEFUROXIME SODIUM x

789mg/vial)

Box x 5 vialsACTAVIS EAD -

BULLGARI

BALKANFARMA-RAZGRAD

AD - BULLGARI (APLIKANT:

BALKANFARMA-RAZGRAD

AD - BULLGARI) Riregj.468/03.09.201

3 7.5

13 LECALPIN

Film-coated tablets

x 20mg

LERCANIDIPINE

HYDROCHLORIDE (eq. To

18.8mg LERCANIDIPINE) Box x 28

ACTAVIS GROUP HF -

ISLANDE

ACTAVIS HF - ISLANDE;

ACTAVIS LIMITED - MALTE;

BALKANPHARMA-DUPNITSA

AD - BULLGARI

REGJ.

307/07.05.2013

7.3

14

TRAUMA-

OINTMENT

WARMING

"MAYRHOFER"

Ointment x (5g +

5g + 0.909g) /

100g

METHYL SALICYLATE +

TEREBINTHINAE

AETHEROLEUM

(rectificatum) + CAPSICI

FRUCTUS (extract with 2.2%

CAPSAICIN)

Box x 1 tube x

40g

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.2009

1.9

15

APIDRA

Solution for

injection x 100

Units/ml - in a

cartrige

INSULIN GLULISINE Box x 5

cartridges x 3ml

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

RIREGJ.

489/10.09.2010

30

Page 2

Page 3: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

3

16

NO-SPA

Solution for

injection x

40mg/2ml

DROTAVERINE

HYDROCHLORIDEBox x 25

SANOFI-AVENTIS

PRIVATE CO.LTD. -

HUNGARI

CHINOIN PHARMACEUTICAL

AND CHEMICAL WORKS

PRIVATE CO.LTD. -

HUNGARI

Riregj.

476/09.09.2013

9.95

17

FLUDARA

Powder for solution

for infusion x

50mg/vial

FLUDARABINE-5'-

DIHYDROGEN

PHOSPHATE

Box x 5 vialsGENZYME EUROPE BV -

HOLLANDE

BAXTER ONCOLOGY GMBH -

GJERMANI, BAYER PHARMA

AG - GJERMANI (APLIKANT:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

392/01.07.2009

741.37

18

HUMATROPE

Powder and

solvent for solution

for injection x 24

mg/3 ml

SOMATROPIN (rDNA origin)

Box x (1

Cartridge x 24

mg + 1 Prefilled

diluent syringe)

LILLY FRANCE - FRANCE

LILLY FRANCE - FRANCE

(APLIKANT: LILLY FRANCE -

FRANCE)

REGJ.

580/27.10.2008

481.44

19 ALVOTIRACETAM

Film-coated tablets

x 250mg LEVETIRACETAM Box x 30

ALVOGEN IPCo. S.ar.1 -

LUKSEMBURG

CAMELOG-BRS LTD -

HUNGARI

REGJ

451/13.08.2013 10

20 ALVOTIRACETAM

Film-coated tablets

x 1000mg LEVETIRACETAM Box x 30

ALVOGEN IPCo. S.ar.1 -

LUKSEMBURG

CAMELOG-BRS LTD -

HUNGARI

REGJ

451/13.08.2013 30

21 AULIN 100 Granules x 100 mg NIMESULIDE

Box x 30

Sachets

HELSINN BIREX

PHARMACEUTICALS

LIMITED - IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE REGJ. 42/28.01.2009 6

22 AULIN 100 Tablets x 100 mg NIMESULIDE Box x 30

HELSINN BIREX

PHARMACEUTICALS

LIMITED - IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE REGJ. 42/28.01.2009 5.5

23 AULIN 3% Gel x 3g/100g NIMESULIDE

Box x 1 tube x

50g

HELSINN BIREX

PHARMACEUTICALS LTD

- IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE

RIREGJ

109/01.03.2013 6

24 ALOXI

Soft capsules x

500mcg

PALONOSETRON

HYDROCHLORIDE Box x 1

HELSINN BIREX

PHARMACEUTICALS LTD

- IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE; CATALENT

PHARMA SOLUTIONS -

SHBA REGJ 49/04.02.2013 70

Page 3

Page 4: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

4

25 ALOXI

Solution for

injection x

250mcg/5ml

PALONOSETRON (as

HYDROCHLORIDE)

Box x 1 vial x

5ml

HELSINN BIREX

PHARMACEUTICALS LTD

- IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE; OSO

BIOPHARMACEUTICALS

MANUFACTURING LLC -

SHBA; PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE REGJ 49/04.02.2013 70

26

DUPHALAC Syrup x 667 g/1 L LACTULOSEBox x Bottle x

200 ml

ABBOTT HEALTHCARE

PRODUCTS BV -

HOLLANDE

ABBOTT HEALTHCARE

PRODUCTS BV - HOLLANDE,

ABBOTT BIOLOGICALS BV -

HOLLANDE

REGJ.

569/24.10.2008

3.53

27 TEVETEN 600

Film Coated

Tablets x 600 mg

EPROSARTAN (as

EPROSARTAN MESYLATE

x 735.8 mg) Box x 28

ABBOTT HEALTHCARE

PRODUCTS BV -

HOLLANDE

ABBOTT HEALTHCARE SAS -

FRANCE,

REGJ.

620/05.11.2008 17

28 BETASERC Tablets x 24 mg

BETAHISTINE

HYDROCHLORIDE Box x 20

SOLVAY PHARMA -

FRANCE

ABBOT HEALTHCARE SAS -

FRANCE

REGJ.

620/05.11.2008 9.6

29 PHYSIOTENS

Film Coated

Tablets x 0.4 mg MOXONIDINE Box x 30

ABBOTT PRODUCTS SAS

- FRANCE

ABBOT HEALTHCARE SAS -

FRANCE

REGJ.

620/05.11.2008 12

30 FEVARIN 100mg

Film Coated

Tablets x 100 mg FLUVOXAMINE MALEATE Box x 30

ABBOTT HEALTHCARE

PRODUCTS BV -

HOLLANDE

ABBOTT HEALTHCARE SAS -

FRANCE

REGJ.

620/05.11.2008 13.5

31 DRIPTANE

Scored tablets x

5mg

OXYBUTYNINE

HYDROCHLORIDE x 5MG

(QUANTITY

CORRESPONDING TO

OXYBUTYNINE BASE x

4.54MG Box x 60

LABORATOIRES

FOURNIER SA - FRANCE

RECIPHARM FONTAINE -

FRANCE

REGJ.

357/10.06.2009 8

32

DUSPATALIN

RETARD Capsules x 200mg

MEBEVERINE

HYDROCHLORIDE Box x 30

ABBOTT PRODUCTS AG -

ZVICER

ABBOTT HEALTHCARE SAS -

FRANCE REGJ. 99/22.02.2010 10

33 LIPANTHYL

Film coated tablets

x 160mg FENOFIBRATE Box x 30

LABORATOIRES

FOURNIER SA - FRANCE

RECIPHARM FONTAINE -

FRANCE

REGJ.

284/11.05.2009 9

Page 4

Page 5: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

5

34 BRUFEN SYRUP

Syrup x 100 mg/5

ml IBUPROFEN

Box x 1 bottle x

100 ml

ABBOTT LABORATORIES

LIMITED - MBRETERIA E

BASHKUAR ABBVIE SRL - ITALI REGJ. 42/28.01.2009 1.89

35 BRUFEN

Coated Tablets x

600 mg IBUPROFEN Box x 30

ABBOTT LABORATORIES

LIMITED - MBRETERIA E

BASHKUAR

ABBVIE DEUTSCHLAND

GMBH & CO.KG - GJERMANI REGJ. 42/28.01.2009 2.63

36 BRUFEN

Oral granules x

600mg/sachet IBUPROFEN

Box x 20

sachets

ABBOTT LABORATORIES

LIMITED - MBRETERI E

BASHKUAR

ABBOTT SRL - ITALI;

ABBOTT LABORATORIES

LIMITED - MBRETERI E

BASHKUAR

REGJ

61/06.02.2013 4

37 DIFMETRE

Effervescent

tablets x (25mg +

75mg + 2mg)

INDOMETHACIN +

CAFFEINE +

PROCHLORPERAZINE

MALEATE Box x 20 ABBOTT SRL - ITALI

E-PHARMA TRENTO SPA -

ITALI

REGJ.

580/29.10.2010 8

38 KLACID

Granules for oral

suspension x

250mg/5ml CLARITHROMYCIN

Box x 1 plastic

bottle x 70ml

ABBOTT LABORATORIES

IRELAND LTD - IRLAND

ABBOTT LABORATORIES

LIMITED - MBRETERI E

BASHKUAR; AESICA

QUEENBOROUGH LIMITED -

MBRETERI E BASHKUAR

REGJ.

662/21.12.2010 10

39 KLACID IV

Powder for

concentrate for

solution for infusion

x 500mg/vial CLARITHROMYCIN

Box x 1 glass

vial

ABBOT LABORATORIES

IRELAND LIMITED -

IRLAND

FAMAR L"AIGLE USINE ST

REMY - FRANCE

REGJ

419/12.10.2011 9

40

SOLUZIONE

FISIOLOGICA

SALF

Solution for

infusion x 0.9%

(w/v) SODIUM CHLORIDE

Plastic bag x

100ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

IPRA SPA - ITALI, S.A.L.F.

SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.65

Page 5

Page 6: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

6

41

SOLUZIONE

FISIOLOGICA

SALF

Solution for

infusion x 0.9%

(w/v) SODIUM CHLORIDE

Plastic bag x

250ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

IPRA SPA - ITALI, S.A.L.F.

SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.78

42

SOLUZIONE

FISIOLOGICA

SALF

Solution for

infusion x 0.9%

(w/v) SODIUM CHLORIDE

Plastic bag x

500ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

IPRA SPA - ITALI, S.A.L.F.

SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 1.2

43

RINGER LATTATO

SALF

Solution for

infusion x (5.46g +

6g + 0.4g +

0.27g)/1000ml

SODIUM LACTATE 60% +

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE

Plastic bag x

500ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 1.1

44

RINGER LATTATO

SALF

Solution for

infusion x (5.46g +

6g + 0.4g +

0.27g)/1000ml

SODIUM LACTATE 60% +

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE

Glass bottle x

500ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.75

45

GLUCOSIO

S.A.L.F.

Solution for

injection x 5%

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

Plastic bag x

100ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.7

46

GLUCOSIO

S.A.L.F.

Solution for

injection x 5%

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

Plastic bag x

250ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.83

47

GLUCOSIO

S.A.L.F.

Solution for

injection x 5%

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

Plastic bag x

500ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 1

48

GLUCOSIO

S.A.L.F.

Solution for

injection x 5%

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

Glass bottle x

100ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.6

49

GLUCOSIO

S.A.L.F.

Solution for

injection x 5%

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

Glass bottle x

250ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.63

Page 6

Page 7: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

7

50

GLUCOSIO

S.A.L.F.

Solution for

injection x 5%

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

Glass bottle x

500ml

S.A.L.F. SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F. SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ.

596/26.11.2012 0.7

51

SODIO

BICARBONATO

SALF

Concentrate for

solution for infusion

x 1 meq/ml

BICARBONATE SODIUM (x

0.84g/10ml)

Box x 5 vials x

10ml

S.A.L.F SPA

LABORATORIO

FARMACOLOGICO - ITALI

S.A.L.F SPA LABORATORIO

FARMACOLOGICO - ITALI

REGJ

307/07.05.2013 1.8

52 SEPTOBORE

Eye drops solution

x (0.1 + 1)%

NAPHAZOLINE NITRATE +

BORIC ACID

Box x 1 flacon x

10ml COOPER SA - GREQI COOPER SA - GREQI

RIREGJ.

531/14.10.2009 1.42

53

TETRACAINE

HYDROCHLORIDE

/ COOPER

Eye Drops Solution

x 0.5 %

TETRACAINE

HYDROCHLORIDE

Box x 1 Flacon

x 10 ml COOPER SA - GREQI COOPER SA - GREQI

REGJ.

714/24.12.2008 1.35

54

IMIDIN FUR

KINDER

Nasal drops,

solution x 0.5mg/ml

XYLOMETAZOLINE

HYDROCHLORIDE

Box x 1 glass

bottle x 10ml

STEINER & CO

DEUTSCHE

ARZNEIMITTELGESELLS

CHAFT MBH & CO KG -

GJERMANI

PHARMA WERNIGERODE

GMBH - GJERMANI; (APL:

PHARMA WERNIGERODE

GMBH - GJERMANI)

RIREGJ

50/04.02.2013 0.9

55 EVIOL

Soft gelatin

capsules x 100mg

DL-ALFA-TOCOPHERYL

ACETATE Box x 20 GAP S.A. - GREQI GAP S.A. - GREQI

RIREGJ.

636/13.11.2008 2.66

Page 7

Page 8: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

8

56 YOVITA

Oral solution x (100

BU/g + 50 BU/g +

100 BU/g + 150

BU/g + 150 BU/g +

150 BU/g + 250

BU/g + 300 BU/g +

1.5mg + 0.42mg +

0.48mg + 1.8mg +

0.6mg + 5.4mg +

0.3mcg + 60 mcg

+21mcg / unit dose

LACTOBACILLUS

ACIDOPHILUS +

LACTOBACILLUS

BULGARICUS +

LACTOBACILLUS LACTIS +

BIFIDO BACTERIUM

BIFIDUM + BIFIDO

BACTERIUM BREVIS +

LACTOBACILLUS

RHAMNOSUS +

LACTOBACILLUS CASEI +

LACTOBACILLUS

SPOROGENES +

MAGNESIUM STEARATE +

THIAMINE

HYDROCHLORIDE +

RIBOFLAVINA +

PANTOTHENIC ACID +

PYRIDOXINE

HYDROCHLORIDE +

NICOTINIC ACID +

CYANOCOBALAMIN +

FOLIC ACID +

PHYTOMENADIONE

Box x 7 flacons

x 8ml KERYOS SPA - ITALI

KERYOS SPA - ITALI;

MONTEFARMACO SPA -

ITALI

RIREGJ

46/30.01.2012 5

57 LOMARIN Tablets x 50mg DIMENHYDRINATE Box x 10 GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI

RIREGJ.

531/14.10.2009 1.52

58 VENOSMINE Tablets x 450mg DIOSMINA Box x 20 GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI

RIREGJ

385/17.06.2013 5.22

59 ECOMI Cream x 1% ECONAZOLE NITRATE

Box x 1 tube x

30g GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI

RIREGJ.

43/28.01.2009 2.8

60 ECOMI

Vaginal solution x

100mg/150ml ECONAZOLE NITRATE

Box x 5

monodose

containers x

150ml GEYMONAT SPA - ITALI

GEYMONAT SPA - ITALI;

C.O.C. FARMACEUTICI SRL -

ITALI

RIREGJ.

531/14.10.2009 7

61 INTRAFER

Oral drops, solution

x 50mg/ml

Fe3+

(as IRON (III)-

POLYMALTOSE COMPLEX

X 178.5MG/ML)

Box x 1 flacon x

30ml GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI

RIREGJ.

43/28.01.2009 3.6

Page 8

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9

62 INTRAFER

Oral solution x

357mg/5ml

IRON POLIMALTOSE

COMPLEX EQ. TO 100mg

IRON (III)

Box x 10

monodose glass

vials x 5ml GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI

RIREGJ.

446/03.08.2010 5

63 KINOGEN

Vaginal solution x

(10% + 1%)

TYROTHRICIN +

HYDROCORTISONE

SODIUM SUCCINATE

Box x 10 single

dose glass vials

x 10ml GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI REGJ. 24/13.01.2011 5.6

64 VENOSMINE Cream x 4% DIOSMINE

Box x 1 tube x

40g GEYMONAT SPA - ITALI GEYMONAT SPA - ITALI REGJ. 24/13.01.2011 2.41

65

ATENIGRON

125mg

Tablets x (100mg +

25mg)

ATENOLOL +

CHLORTALIDONE Box x 28 MITIM SRL - ITALI MITIM SRL - ITALI

REGJ

604/27.11.2012 5.6

66 CEFURIN

Powder for

suspension for I.M.

injection x 1g/4ml

CEFUROXIM (as SODIUM

CEFUROXIM x 1.052g/4ml)

Box x (1 flacon

+ 1 ampoule x

4ml water for

injection)

MAGIS FARMACEUTICI

SPA - ITALI MITIM SRL - ITALI

RIREGJ.

734/28.12.2009 3.19

67 DIFOSFOCIN

Solution for

injection x

500mg/4ml

CITICOLINE (as CITICOLINE

SODIUM x 522mg/4ml)

Box x 5

ampoules x 4ml

MAGIS FARMACEUTICI

SPA - ITALI MITIM SRL - ITALI

REGJ.

427/04.08.2009 7.48

68 DIFOSFOCIN

Solution for

injection x

1000mg/4ml

CITICOLINE (as CITICOLINE

SODIUM x 1044mg/4ml)

Box x 3

ampoules x 4ml

MAGIS FARMACEUTICI

SPA - ITALI MITIM SRL - ITALI

REGJ.

427/04.08.2009 7.7

69 SINTOPEN Tablets x 1g

AMOXICYLLIN ( AS

AMOXICYLLIN

TRIHYDRATE x 1.15g) Box x 12

MAGIS FARMACEUTICI

SPA - ITALI MITIM SRL - ITALI

RIREGJ.

734/28.12.2009 3.5

70 ZITROGRAM

Film-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE) Box x 3

MAGIS FARMACEUTICI

SPA - ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ

604/27.11.2012 6

71 AMOXINA Tablets x 1g

AMOXYCILLIN (as

AMOXYCILLIN

TRIHYDRATE x 1.15g) Box x 12

AESCULAPIUS

FARMACEUTICI SRL -

ITALI MITIM SRL - ITALI

RIREGJ.

648/25.11.2009 3.27

72 CLEVIAN Gel x 1% PIROXICAM

Box x tube x

50g

AESCULAPIUS

FARMACEUTICI S.R.L. -

ITALI MITIM SRL - ITALI

REGJ.

427/04.08.2009 5.61

73 EFRIDOL

Granules for oral

suspension x

100mg NIMESULIDE

Box x 30

sachets

AESCULAPIUS

FARMACEUTICI SRL -

ITALI

MITIM SRL - ITALI; FINE

FOODS NMT SPA - ITALI

RIREGJ.

344/03.06.2010 2.6

Page 9

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10

74 GINENORM

Vaginal solution x

0.1%

IBUPROFEN

ISOBUTANOLAMMONIUM

(eq. to IBUPROFEN x

0.0698g/100ml)

Box x 5 plastic

bottles x 100ml

AESCULAPIUS

FARMACEUTICI SRL -

ITALI

SOFAR SPA - ITALI; MITIM

SRL - ITALI REGJ. 74/01.03.2011 6.38

75 LEVOCARVIT

Oral Solution x

1g/10ml L-CARNITINE

Box x 10 vials x

10ml MITIM SRL - ITALI MITIM SRL - ITALI

REGJ.

427/04.08.2009 6.38

76 MEMOVIT B12

Syrup x (40mg +

500mcg + 60mg)

DL-PHOSPHOSERINE +

CYANOCOBALAMINE (syrup

vials) + L-GLUTAMINE

(dosing cap)

Box x 6 syrup

vials x 10g with

dosing cap

MAGIS FARMACEUTICI

SPA - ITALI MITIM SRL - ITALI

REGJ.

427/04.08.2009 6.55

77 NAPRIUS

Granules for oral

suspension x

500mg/sachet NAPROXEN

Box x 20

sachets

AESCULAPIUS

FARMACEUTICI SRL -

ITALI MITIM SRL - ITALI

REGJ

604/27.11.2012 5.06

78 PANTOXON

Powder and

solvent for solution

for I.M. injection x

1g/3.5ml

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM x

1193mg/3.5ml)

Box x (1 vial of

powder + 1

ampoule of

solvent x 3.5ml)

AESCULAPIUS

FARMACEUTICI S.R.L. -

ITALI MITIM SRL - ITALI

REGJ.

427/04.08.2009 4.96

79 SOLUCIS

Powder for oral

solution x

1500mg/sachet CARBOCISTEINE

Box x 20

sachets

AESCULAPIUS

FARMACEUTICI SRL -

ITALI MITIM SRL - ITALI

REGJ

604/27.11.2012 8.6

80 SOLUCIS Syrup x 50mg/ml CARBOCISTEINE

Box x 1 glass

botlle x 200ml

AESCULAPIUS

FARMACEUTICI SRL -

ITALI MITIM SRL - ITALI

REGJ

604/27.11.2012 3.45

81 SOLUCIS Syrup x 100mg/ml CARBOCISTEINE

Box x 1 glass

botlle x 200ml

AESCULAPIUS

FARMACEUTICI SRL -

ITALI MITIM SRL - ITALI

REGJ

604/27.11.2012 5.4

82 ANGIOFLUX

Solution for

injection x

600LRU/2ml SULODEXIDE

Box x 10

ampoules x 2ml

AESCULAPIUS

FARMACEUTICI SRL -

ITALI

MITIM SRL - ITALI; BIOLAB

SPA - ITALI

RIREGJ.

581/29.10.2010 10.5

83 ANGIOFLUX

Soft capsules x

250 LRU SULODEXIDE Box x 50

AESCULAPIUS

FARMACEUTICI SRL -

ITALI

MITIM SRL - ITALI; BIOLAB

SPA - ITALI; CATALENT

ITALY SPA - ITALI

RIREGJ.

581/29.10.2010 11.4

84 NAPRIUS Gel x 10%(w/w) NAPROXEN

Box x 1 tube x

30g

AESCULAPIUS

FARMACEUTICI SRL -

ITALI MITIM SRL - ITALI

REGJ

604/27.11.2012 6.2

Page 10

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11

85 LEVIORINIL

Oral drops, solution

x 10mg/ml

CETIRIZINE

HYDROCHLORIDE

Box x 1 glass

flacon x 20ml

AESCULAPIUS

FARMACEUTICI SRL -

ITALI

ZENTIVA AS - REPUBLIKA

CEKE; FRANCIA

FARMACEUTICI INDUSTRIA

FARMACO SRL - ITALI;

MITIM SRL - ITALI

REGJ

604/27.11.2012 5.3

86

NYSTAMYSYN/FA

RMASYN

Oral suspension x

100 000 IU/ml NYSTATIN

Box x 1 flacon x

50ml FARMASYN S.A. - GREQI RAFARM SA - GREQI

REGJ.

284/11.05.2009 2.38

87

AMOXICILLINE EG

LABO

Dispersible tablets

x 1g

AMOXICILLIN (AS

AMOXICILLIN

TRIHYDRATE) Box x 14

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE SOPHARTEX - FRANCE

RIREGJ

433/2/ 28.09.2012 2.36

88 BETAHISTINE EG Tablets x 8mg

BETAHISTINE

HYDROCHLORIDE Box x 30

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

CATALENT GERMANY

SCHORNDORF GMBH -

GJERMANI

RIREGJ

423/11.07.2013 1.2

89

ECONAZOLE EG

1% Cream x 1% (w/w) ECONAZOLE NITRATE

Box x tube x

30g

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

LABORATOIRES

CHEMINEAU - FRANCE

RIREGJ

266/19.04.2013 1.21

90

ECONAZOLE EG

1%

Dermatological

emulsion x 1%

(w/w) ECONAZOLE NITRATE

Box x 1 flacon x

30g

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

LABORATOIRES

CHEMINEAU - FRANCE

RIREGJ

266/19.04.2013 1.36

91 KENDIX Cream x 5% ACYCLOVIR

Box x 1 tube x

2g

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

STADA ARZNEIMITTEL AG -

GJERMANI

REGJ

132/26.03.2012 2.43

92

NIFUROXAZIDE

EG Capsules x 200mg NIFUROXAZIDE Box x 28

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

LABORATOIRES BTT -

FRANCE

RIREGJ

46/30.01.2012 1.67

93

PARACETAMOL

EG

Effervescent

tablets x 1000mg PARACETAMOL Box x 8

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

SMB TECHNOLOGY SA -

BELGJIKE

REGJ

132/26.03.2012 1.17

Page 11

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12

94

PHLOROGLUCIN

OL EG

Orodispersible

tablets x 80mg PHLOROGLUCINOL Box x 10

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

OPODEX INDUSTRIE -

FRANCE

RIREGJ

260/12.06.2012 0.96

95

PREDNISONE EG

20MG Tablets x 20mg PREDNISONE Box x 20

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

PHARBIL WALTROP GMBH -

GJERMANI; DELPHARM

LILLE SAS - FRANCE

REGJ.

577/30.10.2009

96

PREDNISOLONE

EG 20MG

Effervescent

tablets x 20mg

PREDNISOLONE (in form of

PREDNISOLONE SODIUM

METASULFOBENZOATE x

31.44mg)

Box x 1 glass

bottle x 20

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

LABORATOIRE FAMAR SA -

GREQI; DELPHARM LILLE

SAS - FRANCE

REGJ.

577/30.10.2009 2.56

97

RISPERIDONE EG

1MG/ML

Oral solution x

1mg/ml RISPERIDONE

Box x 1 flacon x

60ml

EG LABO -

LABORATOIRES

EUROGENERICS -

FRANCE

DRAGENOPHARM

APOTHEKER PUSCHL GMBH

- GJERMANI; STADA

ARZNEIMITTEL AG -

GJERMANI

REGJ.

690/16.12.2009 11.5

98

ROXITHROMYCIN

E EG

Film coated tablets

x 150 mg ROXITHROMYCINE Box x 10

EG LABO -

LABORATOIRES

EUROGENERICS -

FRANCE

LABORATOIRES BTT -

FRANCE

REGJ.

619/05.11.2008 3

99

SPIRAMYCINE/ME

TRONIDAZOLE

EG

Film-coated tablets

x (1.5 MUI +

250mg)

SPIRAMYCINE +

METRONIDAZOLE Box x 10

EG LABO-

LABORATOIRES

EUROGENERICS -

FRANCE

ROTTENDORF PHARMA -

FRANCE

RIREGJ

46/30.01.2012 3.93

100

THIOCOLCHICOSI

DE EG

Breakable tablets x

4mg THIOCOLCHICOSIDE Box x 24

EG LABO -

LABORATOIRES

EUROGENERICS -

FRANCË

BLUEPHARMA-INDUSTRIA

FARMACEUTICA SA -

PORTUGALI

RIREGJ.

269/28.04.2010 3.67

101 ATACAND Tablets x 8mg CANDESARTAN CILEXETIL Box x 28

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI

(APL: ASTRAZENECA -

MBRETERI E BASHKUAR)

REGJ.

310/17.05.2010 8.96

102 ATACAND Tablets x 16mg CANDESARTAN CILEXETIL Box x 28

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI

(APL: ASTRAZENECA -

MBRETERI E BASHKUAR)

REGJ.

310/17.05.2010 16

Page 12

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13

103 BETALOC

Solution for

injection x 1mg/ml METOPROLOL TARTRATE

Box x 5

ampoules x 5 ml

"ASRTAZENECA AB" -

SUEDI

"ASRTAZENECA AB" - SUEDI

DHE ME APLIKANT PER

CERTIFIKATE

"ASTRAZENECA R&D

MOLINDAL" - SUEDI

RIREGJ

366/23.09.2011 12.3

104 CASODEX

Film - coated

tablets x 50mg BICALUTAMIDE Box x 28

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

CORDEN PHARMA GMBH -

GJERMANI

RIREGJ

506/6.12.2011 32.11

105 CASODEX

Film - coated

tablets x 150mg BICALUTAMIDE Box x 28

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

CORDEN PHARMA GMBH -

GJERMANI

RIREGJ

506/6.12.2011 254.41

106 CRESTOR

Film - coated

tablets x 5mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 5.2mg) Box x 28

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR;

CORDEN PHARMA GMBH -

GJERMANI; IPR

PHARMACEUTICALS

INCORPORATED - PORTO

RIKO

RIREGJ

506/6.12.2011 11.76

107 CRESTOR

Film - coated

tablets x 10mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 5.2mg) Box x 28

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR;

CORDEN PHARMA GMBH -

GJERMANI; IPR

PHARMACEUTICALS

INCORPORATED - PORTO

RIKO

RIREGJ

506/6.12.2011 14.56

108 CRESTOR

Film - coated

tablets x 20mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 5.2mg) Box x 28

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR;

CORDEN PHARMA GMBH -

GJERMANI; IPR

PHARMACEUTICALS

INCORPORATED - PORTO

RIKO

RIREGJ

506/6.12.2011 23.24

Page 13

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14

109 CRESTOR

Film - coated

tablets x 40mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 5.2mg) Box x 28

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR;

CORDEN PHARMA GMBH -

GJERMANI; IPR

PHARMACEUTICALS

INCORPORATED - PORTO

RIKO

RIREGJ

506/6.12.2011 32.94

110

RHINOCORT

AQUA

Nasal spray,

suspension x

64µg/dose BUDESONIDE

Box x 1 flacon x

120 doses

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI

(APL: ASTRAZENECA -

MBRETERI E BASHKUAR)

REGJ.

140/15.04.2011 6

111 SEROQUEL XR

Prolonged release

tablets x 400mg

QUETIAPINE (AS

QUETIAPINE FUMARATE x

460.5mg) Box x 60

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR

REGJ.

222/08.04.2009 166.2

112 SEROQUEL XR

Prolonged release

tablets x 300mg

QUETIAPINE (AS

QUETIAPINE FUMARATE x

345.38mg) Box x 60

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR

REGJ.

222/08.04.2009 110.09

113 SEROQUEL XR

Prolonged release

tablets x 200mg

QUETIAPINE (AS

QUETIAPINE FUMARATE x

230.26mg) Box x 60

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR

REGJ.

222/08.04.2009 83.48

114 SEROQUEL XR

Prolonged release

tablets x 50mg

QUETIAPINE (AS

QUETIAPINE FUMARATE x

57.56mg) Box x 60

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR

REGJ.

222/08.04.2009 43.1

115

ZOLADEXImplant x

3.6mg/dose

GOSERELIN (as

GOSERELIN ACETATE)

Box x 1 pre-

filled syringe

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR

RIREGJ.

47/30.01.201269.16

116

ZOLADEX LAImplant x

10.8mg/dose

GOSERELIN (as

GOSERELIN ACETATE)

Box x 1 pre-

filled syringe

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR

RIREGJ.

47/30.01.2012215.59

117 AZELDERM Cream x 20% AZELAIC ACID

Box x 1 tube x

30g KLEVA S.A. - GREQI KLEVA S.A. - GREQI

REGJ.

192/19.03.2009 4.7

118 ANTITOSS Syrup x 7.5mg/5ml BUTAMIRATE CITRATE

Box x 1 flacon x

200ml KLEVA S.A. - GREQI KLEVA S.A. - GREQI

REGJ.

192/19.03.2009 3

Page 14

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15

119 DEPRETAL

Film coated tablets

x 20mg

CITALOPRAM

HYDROBROMIDE x 25MG

EQUIVALENT TO

CITALOPRAM x 20MG Box x 28 KLEVA S.A. - GREQI

KLEVA S.A. - GREQI; HELP

SA - GREQI

REGJ.

396/07.07.2009 5.1

120 DEPRETAL

Film coated tablets

x 40mg

CITALOPRAM

HYDROBROMIDE x 50MG

EQUIVALENT TO

CITALOPRAM x 40MG Box x 28 KLEVA S.A. - GREQI

KLEVA S.A. - GREQI; HELP

SA - GREQI

REGJ.

396/07.07.2009 6.7

121

TEXTAZO

Powder for solution

for infusion x (4g +

500mg)/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

4.170g) + TAZOBACTAM (as

TAZOBACTAM SODIUM x

536.6mg/vial)

Box x 1 vial"PHARMATEX ITALIA

SRL" ITALI"MITIM SRL" ITALI Regj.481/09.09.2013

10

122

PHAREPA

Solution for

injection for I.V use

x 25.000 IU/5ml

HEPARIN SODIUMBox x 10 vials x

5ml

""PHARMATEX ITALIA

SRL" ITALI"FISIOPHARMA SRL" ITALI Regj.422/11.07.2013

40

123

CALCIUM

GLUCONATE

LAVOISIER 10%

Solution for

injection x (700mg

+ 328mg)/10ml

CALCIUM GLUCONATE +

CALCIUM

GLUCOHEPTONATE

Box x 10

ampoules x

10ml

C.D.M. LAVOISIER -

FRANCE C.D.M. LAVOISIER - FRANCE

REGJ.

664/21.12.2010 3.15

124

CALCIUM

GLUCONATE

LAVOISIER 10%

Solution for

injection x (700mg

+ 328mg)/10ml

CALCIUM GLUCONATE +

CALCIUM

GLUCOHEPTONATE

Box x 100

ampoules x

10ml (for

hospital use)

C.D.M. LAVOISIER -

FRANCE C.D.M. LAVOISIER - FRANCE

REGJ.

664/21.12.2010 31.5

125

METRONIDAZOLE

LAVOISIER

Solution for

infusion x

500mg/100ml

METRONIDAZOLE

Box x 24 glass

vials x 100ml

(for hospital use

only)

C.D.M. LAVOISIER -

FRANCEC.D.M. LAVOISIER - FRANCE

REGJ.

212/25.05.2011

19.2

126

TRAMADOL

LAVOISIER

Solution for

injection x 50mg/ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 2ml

C.D.M. LAVOISIER -

FRANCEC.D.M. LAVOISIER - FRANCE

REGJ.

188/12.05.20111.45

127

ZINERYT

Powder and

Solvent for 30 ml

Lotion x (40 mg +

12 mg)/ml

ERYTHROMYCIN + ZINC

ACETATE DIHYDRATE

Box x (1 Bottle

of powder + 1

Bottle of liquid +

1 Applicator)

ASTELLAS PHARMA B.V. -

HOLLANDË

ASTELLAS PHARMA

EUROPE B.V. - HOLLANDË

(APL: ASTELLAS PHARMA

EUROPE B.V. - HOLLANDË)

REGJ.

197/25.03.2009

11.7

Page 15

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16

128 LOCOIDON Cream x 0.1%

HYDROCORTISONE 17-

BUTYRATE

Box x 1 tube x

30g

ASTELLAS PHARMA SPA -

ITALI TEMMLER ITALIA SRL - ITALI

RIREGJ.

71/09.02.2010 4.46

129 LOCOIDON

Cutaneous solution

x 0.1g/100ml

HYDROCORTISONE 17-

BUTYRATE

Box x 1 flacon x

30ml

ASTELLAS PHARMA SPA -

ITALI TEMMLER ITALIA SRL - ITALI

RIREGJ.

71/09.02.2010 4.46

130 VESICARE 5MG

Film-coated tablets

x 5mg SOLIFENACIN SUCCINATE Box x 30

ASTELLAS PHARMA

EUROPE BV - HOLLANDE

ASTELLAS PHARMA

EUROPE BV - HOLLANDE

RIREGJ

266/19.04.2013 34

131 VESICARE 10MG

Film-coated tablets

x 10mg SOLIFENACIN SUCCINATE Box x 30

ASTELLAS PHARMA

EUROPE BV - HOLLANDE

ASTELLAS PHARMA

EUROPE BV - HOLLANDE

RIREGJ

266/19.04.2013 42.58

132 ASTON

Film-coated tablets

x 70mg

ALENDRONIC ACID (as

SODIUM ALENDRONATE

TRIHYDRATE) Box x 4

BIOHEALTH

PHARMACEUTICALS

S.R.L. - ITALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI; SPECIAL

PRODUCTS LINE SPA - ITALI

REGJ

186/26.04.2012 18

133 TEDIM

Hard-capsules x

200mg FLUCONAZOLE Box x 7

BIOHEALTH

PHARMACEUTICALS SRL

- ITALI

LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI; GET SRL - ITALI

REGJ

297/25.06.2012 6

134 UROCINOX

Hard capsules x

500 mg CINOXACIN Box x 20

BIOHEALTH

PHARMACEUTICALS

S.R.L. - ITALI

SPECIAL PRODUCTS LINE

SPA - ITALI

REGJ.

184/18.03.2009 11

135 ACICLOVIR ABC

Oral suspension x

400mg/5ml ACICLOVIR

Box x 1 vial x

100ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI, FRANCIA

FARMACEUTICI INDUSTRIA

FARMACO BIOLOGICA SRL -

ITALI

REGJ.

284/11.05.2009 5.24

136 ACICLOVIR ABC Cream x 5% ACICLOVIR

Box x tube x

10g

ABC FARMACEUTICI SPA

- ITALI

LISAPHARMA SPA - ITALI,

FRANCIA FARMACEUTICI

INDUSTRIA FARMACO

BIOLOGICA SRL - ITALI

REGJ.

284/11.05.2009 3

137

ALPRAZOLAM

ABC Tablets x 0.25mg ALPRAZOLAM Box x 20

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI, DOPPEL

FARMACEUTICI SPA - ITALI

REGJ.

405/14.07.2009 1

Page 16

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17

138

ALPRAZOLAM

ABC Tablets x 0.5mg ALPRAZOLAM Box x 20

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI, DOPPEL

FARMACEUTICI SPA - ITALI

REGJ.

405/14.07.2009 1.2

139

ALPRAZOLAM

ABC Tablets x 1mg ALPRAZOLAM Box x 20

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI, DOPPEL

FARMACEUTICI SPA - ITALI

REGJ.

405/14.07.2009 2.1

140

ALPRAZOLAM

ABC

Oral drops solution

x 0.75mg/ml ALPRAZOLAM

Box x 1 flacon x

20ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

405/14.07.2009 3.3

141

AMOXICILLINA

ABC

Dispersible tablets

x 1 g

AMOXICILLIN ( AS

AMOXICILLIN TRIHYDRATE

x 1150 mg) Box x 12

ABC FARMACEUTICI SPA

- ITALI

FRANCIA FARMACEUTICI

SRL - ITALI

REGJ.

180/18.03.2009 3.32

142

BROMAZEPAM

ABC

Solution for oral

drops x 2.5mg/ml BROMAZEPAM

Box x flacon x

20ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI; DOPPEL

FARMACEUTICI SPA - ITALI

REGJ.

421/29.07.2009 3

143

CALCIO

CARBONATO +

VITAMINA D3 ABC

Effervescent

granules x

(1000mg + 880 IU)

CALCIUM (AS CALCIUM

CARBONATE x 2500mg) +

COLECALCIFEROL

Box x 30

sachets

ABC FARMACEUTICI SPA

- ITALI LA.FA.RE. SRL - ITALI

REGJ.

180/18.03.2009 3.82

144

CEFOTAXIME

ABC

Powder & solvent

for solution for

injection I.M. x 1g

CEFOTAXIME ( AS

CEFOTAXIME SODIUM x

1.048 g)

Box x 1 flacon

with powder + 1

ampoule with

solvent x 4ml

ABC FARMACEUTICI SPA

- ITALI

SPECIAL PRODUCT'S LINE

SRL - ITALI; LA.FA.RE. SRL -

ITALI

REGJ.

180/18.03.2009 3.4

145

CEFTRIAXONE

ABC

Powder & solvent

for solution for

injection I.M. x 1g

CEFTRIAXONE ( AS

CEFTRIAXONE SODIUM X

3.5 H2O x 1.193 g)

Box x 1 flacon

with powder + 1

ampoule with

solvent x 3.5ml

ABC FARMACEUTICI SPA

- ITALI

LABORATORIO

FARMACEUTICO CT SRL -

ITALI; GET SRL - ITALI

REGJ.

180/18.03.2009 3.5

146

CITALOPRAM

ABC

Oral drops solution

x 40mg/ml

CITALOPRAM ( AS

CITALOPRAM

HYDROCHLORIDE x

44.48mg/ml)

Box x 1 flacon x

15 ml

ABC FARMACEUTICI SPA

- ITALI

HELP SA

PHARMACEUTICALS -

GREQI; ABC FARMACEUTICI

SPA - ITALI

REGJ.

180/18.03.2009 4.7

Page 17

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18

147

DELORAZEPAM

ABC

Solution for oral

drops x 0.1% DELORAZEPAM

Box x flacon x

20ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

421/29.07.2009 3.8

148 DIAZEPAM ABC

Solution for oral

drops x 5mg/ml DIAZEPAM

Box x flacon x

20ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

421/29.07.2009 2.7

149

GENTAMICINA E

BETAMETASONE

ABC

Cream x (0.1% +

0.1%)

GENTAMYCIN ( AS

GENTAMYCIN SULPHATE x

0.166g/100g) +

BETAMETHASONE (AS

BETAMETHASONE

VALERATE x 0.122g/100g )

Box x 1 tube x

30g

ABC FARMACEUTICI SPA

- ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ.

180/18.03.2009 3.2

150

GENTAMICINA

ABC Cream x 0.1%

GENTAMYCIN ( AS

GENTAMYCIN SULPHATE x

0.166g/100g)

Box x 1 tube x

30g

ABC FARMACEUTICI SPA

- ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ.

180/18.03.2009 3.1

151

LORMETAZEPAM

ABC

Oral drops solution

x 2.5mg/ml LORMETAZEPAM

Box x 1 flacon x

20ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

369/17.06.2009 3.4

152 TRIAZOLAM ABC Tablets x 0.25mg TRIAZOLAM Box x 10

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

421/29.07.2009 2.6

153 TRIAZOLAM ABC Tablets x 0.25mg TRIAZOLAM Box x 20

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

421/29.07.2009 2.8

154

CLODRONATO

ABC

Solution for

intravenous

infusion x

300mg/10ml DISODIUM CLODRONATE

Box x 6

ampoules x

10ml

ABC FARMACEUTICI SPA

- ITALI

LAB. IT. BIOCHIM. FARM.CO

LISAPHARMA SPA - ITALI

REGJ.

690/16.12.2009 15

155

DOMPERIDONE

ABC Tablets x 10mg DOMPERIDONE Box x 30

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI; FRANCIA

FARMACEUTICI SRL - ITALI

REGJ.

568/27.10.2009 3.5

156

FLUNISOLIDE

ABC

Nebulising solution

x 0.1% FLUNISOLIDE

Box x 1 glass

bottle x 30ml

ABC FARMACEUTICI SPA

- ITALI

C.O.C. FARMACEUTICI

S.R.L. - ITALI; FARMILA -

THEA FARMACEUTICI S.P.A.

- ITALI

REGJ.

690/16.12.2009 5

157

NORFLOXACINA

ABC

Hard capsules x

400mg NORFLOXACIN Box x 14

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

568/27.10.2009 3.8

Page 18

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19

158

POLIETILENGLIC

OLE + SALI DI

SODIO E

POTASSIO ABC

Powder for oral

solution x (14.580g

+ 1.422g + 0.422g

+ 0.365g +

0.185g)/sachet

MACROGOL 4000 +

ANHYDROUS SODIUM

SULPHATE + SODIUM

BICARBONATE + SODIUM

CHLORIDE + POTASSIUM

CHLORIDE

Box x 16

sachets x 17.5g

ABC FARMACEUTICI SPA

- ITALI

LAMP S. PROSPERO S.P.A. -

ITALI; BIOLAB SPA - ITALI;

SIGMAR ITALIA S.P.A. - ITALI

REGJ.

690/16.12.2009 7.47

159

SUCRALFATO

ABC

Granules for oral

suspension x 2g SUCRALFATE

Box x 30

sachets

ABC FARMACEUTICI SPA

- ITALI

ALFA WASSERMANN S.P.A. -

ITALI; LAMP SAN

PROSPERO S.P.A. - ITALI

REGJ.

690/16.12.2009 3

160 RINALGIT

Oral drops solution

x 10mg/ml

CETIRIZINE

DIHYDROCHLORIDE

Box x 1 flacon x

20ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

568/27.10.2009 3.5

161 TONOGEN

Powder and

Solvent for Oral

Solution x (2mg +

1mg)/10ml

HEMATOPORPHYRIN

HYDROCHLORIDE (solvent

vial) + CYANOCOBALAMIN

(cartridge cap)

Box x 10 vials x

10ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

REGJ.

448/26.08.2009 7

162 SPASMODIL

Solution for

injection x 10mg/ml

PIPETHANATE

ETHOBROMIDE

Box x 6

ampoules x 1ml

ABC FARMACEUTICI SPA

- ITALI

DOPPEL FARMACEUTICI

SRL - ITALI; ABC

FARMACEUTICI SPA - ITALI;

BIOLOGICI ITALIA

LABORATORIES - ITALI;

FARMACEUTICI PROCESMA

S.R.L. - ITALI

RIREGJ.

676/31.12.2010 4.2

163 SPASMODIL

Film-coated tablets

x 20mg

PIPETHANATE

ETHOBROMIDE Box x 30

ABC FARMACEUTICI SPA

- ITALI

DOPPEL FARMACEUTICI

SRL - ITALI, ABC

FARMACEUTICI SPA - ITALI

RIREGJ.

516/24.09.2010 4.53

164 URSOBIL HT

Modified release

hard capsules x

450mg URSODEOXYCHOLIC ACID Box x 20

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

RIREGJ.

489/10.09.2010 9

Page 19

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20

165 COLIFAGINA

Oral suspension x

(80 milliard + 5

milliard + 4 milliard

+ 4 milliard + 4

milliard + 1 milliard

+ 1 milliard + 1

milliard)/vial

ESCHERICHIA COLI 01, 02,

055, 0111 + BACILLUS

PUMILUS + MORGANELLA

MORGANI + ALCALIGENES

FAECALIS + SHIGELLA

FLEXNERI +

ENTEROCOCCUS

FAECALIS + BACILLUS

SUBTILIS + PROTEUS

VULGARIS

Box x 10 vials x

6.5ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI; LAMPUGNANI

FARMACEUTICI SPA - ITALI REGJ. 24/13.01.2011 6

166

PARACETAMOLO

ABC

Oral solution x

120mg/5ml PARACETAMOL

Box x 1 glass

bottle x 120ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI REGJ. 24/13.01.2011 1.8

167 ANSIMAR Tablets x 400mg DOXOPHYLLINE Box x 20

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

RIREGJ.

489/10.09.2010 4.53

168 ANSIMAR Syrup x 20mg/ml DOXOPHYLLINE

Box x 1 glass

bottle x 200ml

ABC FARMACEUTICI SPA

- ITALI

ABC FARMACEUTICI SPA -

ITALI

RIREGJ.

489/10.09.2010 4.53

169 DIAMEL Tablets x 2mg GLIMEPIRIDE Box 30

BENEDETTI & CO SPA -

ITALI

ALI RAIF ILAC SANAYI AS -

TURQI; EDMOND PHARMA

SRL - ITALI; BIOLAB SPA -

ITALI

REGJ

186/26.04.2012 5

170 DIAZID Tablets x 80mg GLICLAZIDE Box x 40

BENEDETTI & CO. SPA -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

284/11.05.2009 5

171 KINOX

Film-coated tablets

x 750mg

CIPROFLOXACIN (AS

CIPROFLOXACIN

HYDROCHLORIDE

MONOHYDRATE x 873mg) Box x 12

BENEDETTI E CO. SPA -

ITALI

SPECIAL PRODUCT´S LINE

SPA - ITALI

REGJ

45/30.01.2012 8

172 ETAZIM

Powder and

Solvent for Solution

for Injection x 1 g/3

ml

CEFTAZIDIME (as

CEFTAZIDIME

PENTAHYDRATE x 1.164

g/3ml)

Box x (1 Vial of

Powder + 1

Ampoule of

Solvent x 3 ml)

BENEDETTI & CO SPA -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

369/17.06.2009 4.6

173 NIMESULIDE BIG

Granules for oral

suspension x

100mg NIMESULIDE

Box x 30

sachets BENEDETTI SPA - ITALI

LAMP S.PROSPERO - ITALI,

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

284/11.05.2009 2.5

Page 20

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21

174 NIMOBRAIN

Oral drops solution

x 30mg/0.75ml NIMODIPINE

Box x 1 glass

bottle x 25ml

BENEDETTI & CO S.P.A. -

ITALI

SPECIAL PRODUCT'S LINE

S.P.A. - ITALI

REGJ

604/27.11.2012 9

175 KEFORAL Tablets x 1g

CEFALEXIN (as CEFALEXIN

MONOHYDRATE x

1049.3mg) Box x 8 EG SPA - ITALI

FACTA FARMACEUTICI SPA -

ITALI

REGJ.

596/26.11.2012 5

176 BIDIEN

Cream x

0.025g/100g BUDESONIDE

Box x tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 3.5

177 BIDIEN

Ointment x

0.025g/100g BUDESONIDE

Box x tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 3.5

178 BIDIEN

Cutaneous solution

x 0.025g/100g BUDESONIDE

Box x flacon x

30ml

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 3.5

179 CITRIZAN

Gel x 800.000

IU/100g CATALASE EQUINE

Box x tube x

50g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 5.2

180

CITRIZAN

ANTIBIOTICO

Gel x (800.000

IU/100g +

0.1g/100g)

CATALASE EQUINE +

GENTAMYCINE SULPHATE

Box x tube x

50g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 6.3

181ERITROMICINA IDI Gel x 3% (w/w) ERYTHROMYCIN

Box x tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ.

334/20.05.2013 6.25

182CISTIDIL Tablet x 500mg L- CISTEINE Box x 30

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ.

334/20.05.2013 6.58

183 ALOXIDIL

Cutaneous solution

x 2g/100g MINOXYDIL (dci)

Box x flacon x

60ml

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 8.68

184 PAF

Cutaneous solution

x 50%

BISBUTYLCARBOETHYLEN

E

Box x 1 flacon x

5g LOFARMA SPA - ITALI

LOFARMA SPA - ITALI;

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

RIREGJ

458/19.08.2013 7.6

185 ERITROMICINA IDI Cream x 3% (w/w) ERYTHROMYCIN BASE

Box x 1 tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 6.25

186 ERITROMICINA IDI

Cutaneous solution

x 3% (w/v) ERYTHROMYCIN BASE

Box x 1 flacon x

40ml

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 6.25

Page 21

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22

187 GENTAMICINA IDI

Cream x 0.1%

(w/w)

GENTAMICIN (as

GENTAMICIN SULPHATE x

0.166g/100g)

Box x 1 tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 5.71

188

GENTAMICINA E

BETAMETASONE

IDI

Cream x (0.1% +

0.1%)w/w

GENTAMICIN (as

GENTAMICIN SULPHATE x

0.166g/100g) +

BETAMETHASONE (as

BETAMETHASONE

VALERATE x 0.122g/100g)

Box x 1 tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 5.71

189 BAMIFIX

Coated tablets x

600mg BAMIFYLLINE Box x 30

CHIESI FARMACEUTICI

SPA - ITALI

CHIESI FARMACEUTICI SPA -

ITALI

RIREGJ

506/6.12.2011 5.5

190 CLENIL

Suspension for

aerosol x

0.8mg/2ml

BECLOMETHASONE

DIPROPIONATE

Box x 20 flacons

x 2ml

CHIESI FARMACEUTICI

S.P.A. - ITALI

CHIESI FARMACEUTICI

S.P.A. - ITALI

RIREGJ

385/17.06.2013 6.4

191 CLIPPER

Gastro-resistant

modified released

tablets x 5mg

BECLOMETASONE

DIPROPIONATE Box x 30

CHIESI FARMACEUTICI

S.P.A. - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI REGJ. 24/13.01.2011 48.1

192 BRAMITOB

Nebulising solution

x 300mg/4ml TOBRAMYCIN

Box x 56 single-

dose vials x 4ml

CHIESI FARMACEUTICI

S.P.A. - ITALI

HOLOPACK

VERPACKUNGSTECHNIK

GMBH - GJERMANI, CHIESI

FARMACEUTICI S.P.A. -

ITALI; GENETIC SPA - ITALI

REGJ.

369/17.06.2009 1351.5

193 FLUIBRON

Solution for

nebulisation x

15mg/2ml

ABROXOL

HYDROCHLORIDE

Box x 20

monodose vials

x 2ml

CHIESI FARMACEUTICI

SPA - ITALI

CHIESI FARMACEUTICI SPA -

ITALI

RIREGJ

75/17.02.2012 6

194 CUROSURF

Suspension for

endotracheobronch

ial installation

(inhalation) x

80mg/ml

PHOSPHOLIPIDS

FRACTION FROM PORCINE

LUNG

Box x 2 flacons

x 1.5ml

CHIESI FARMACEUTICI

S.P.A. - ITALI

CHIESI FARMACEUTICI

S.P.A. - ITALI; FIDIA

FARMACEUTICI SPA - ITALI

RIREGJ.

165/24.03.2010 400

Page 22

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23

195 CLENIL

Pressurised

inhalation solution

x 50mcg/metered

dose

BECLOMETHASONE

DIPROPIONATE

Box x 1 flacon x

200 actuations

CHIESI FARMACEUTICI

S.P.A. - ITALI

CHIESI FARMACEUTICI

S.P.A. - ITALI

RIREGJ.

734/28.12.2009 3.8

196

CLENIL

COMPOSITUM

Pressurized

Inhalation

Suspension x (250

mcg + 100 mcg)

BECLOMETASONE

DIPROPIONATE +

SALBUTAMOL

Box x 1

Container under

pressure x 200

Metered doses PROMEDICA SRL - ITALI

CHIESI FARMACEUTICI SPA -

ITALI

REGJ.

197/25.03.2009 5.8

197

CLENIL

COMPOSITUM

Suspension for

aerosol x

40mg/100ml +

80mg/100ml

BECLOMETHASONE

DIPROPIONATE +

SALBUTAMOL (AS

SALBUTAMOL BASE)

Box x 10 flacons

x 2ml PROMEDICA SRL - ITALI

CHIESI FARMACEUTICI

S.P.A. - ITALI

RIREGJ

385/17.06.2013 5.8

198 IBUTOP GEL Gel x 5g/100g IBUPROFEN

Box x 1 tube x

20g

DOLORGIET GMBH &

CO.KG - GJERMANI

DOLORGIET GMBH & CO.KG

- GJERMANI

RIREGJ

325/15.05.2013 1.5

199 IBUTOP GEL Gel x 5g/100g IBUPROFEN

Box x 1 tube x

50g

DOLORGIET GMBH &

CO.KG - GJERMANI

DOLORGIET GMBH & CO.KG

- GJERMANI

RIREGJ

325/15.05.2013 2.5

200 MIGRANERTON

Capsules x (500mg

+ 5mg)

PARACETAMOL +

METOCLOPRAMIDE

HYDROCHLORIDE

MONOHYDRATE Box x 10

DOLORGIET GMBH &

CO.KG - GJERMANI

DOLORGIET GMBH & CO.KG

- GJERMANI

REGJ.

369/17.06.2009 2.99

201 IBUTOP CREAM Cream x 5g/100g IBUPROFEN

Box x 1 tube x

20g

DOLORGIET GMBH &

CO.KG - GJERMANI

DOLORGIET GMBH & CO.KG

- GJERMANI

RIREGJ

325/15.05.2013 1.2

202 IBUTOP CREAM Cream x 5g/100g IBUPROFEN

Box x 1 tube x

50g

DOLORGIET GMBH &

CO.KG - GJERMANI

DOLORGIET GMBH & CO.KG

- GJERMANI

RIREGJ

325/15.05.2013 2.2

203 MERESA Capsules x 50mg SULPIRIDE Box x 20

DOLORGIET GMBH &

CO.KG - GJERMANI

DOLORGIET GMBH & CO.KG

- GJERMANI

REGJ

140/19.03.2013 1.9

204

SODIO CLORURO

MONICO

Solution for

infusion x

0.9%(w/v) SODIUM CHLORIDE

1 Plastic bag x

250ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 0.7

205

SODIO CLORURO

MONICO

Solution for

infusion x

0.9%(w/v) SODIUM CHLORIDE

1 Plastic bag x

500ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 0.7

206

GLUCOSIO

MONICO

Solution for

infusion x 5% (w/v)

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

1 Plastic bag x

250ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 0.7

Page 23

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24

207

GLUCOSIO

MONICO

Solution for

infusion x 5% (w/v)

GLUCOSE (as GLUCOSE

MONOHYDRATE x

55g/1000ml)

1 Plastic bag x

500ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 0.7

208

MANNITOLO

MONICO

Solution for

infusion x 18%

(w/v) MANNITOL

1 Glass bottle x

100ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 1

209

MANNITOLO

MONICO

Solution for

infusion x 18%

(w/v) MANNITOL

1 Glass bottle x

250ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 0.7

210

EFEDRINA

CLORIDRATO

MONICO

Solution for I.M

injection x 25mg/ml

EPHEDRINE

HYDROCHLORIDE

Box x 5

ampoules x 1ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

433/17.09.2012 3.55

211 DEKAMIN

Solution for

infusion x (12.8g +

8.707g + 5.9g +

5.9g + 5.6g +

5.298g + 5.18g +

4.4g + 4.323g +

4.24g + 4.14g +

3.7g + 3.14g +

2.64g + 1.32g +

0.5g +

0.06g)/1000ml

GLYCINE + L-ARGININE

HYDROCHLORIDE (eq. to

7.2g/1000ml L-ARGININE) +

L-PHENYLALANINE + L-

LEUCINE + L-METHIONINE

+ L-SERINE + L-LYSINE

HYDROCHLORIDE + (eq. to

4.24g/1000ml L-LYSINE) + L-

GLUTAMIC ACID + L-

ALANINE + L-HISTIDINE

HYDROCHLORIDE

MONOHYDTRATE (eq. to

3.2g/1000ml L-HISTIDINE) +

L-VALINE + L-PROLINE + L-

ISOLEUCINE + L-ASPARTIC

ACID + L-THREONINE + L-

TRYPTOPHAN + L-

TRYOSINE + PYRIDOXINE

HYDROCHLORIDE (eq. to

0.05g/1000ml PYRIDOXINE)

1 Glass bottle x

250ml MONICO SPA - ITALI MONICO SPA - ITALI REGJ 3/07.01.2013 6

Page 24

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25

212

CALCIO

GLUCONATO

MONICO

Solution for

injection for IV use

x 1000mg/10ml

CALCIUM GLUCONATE

MONOHYDRATE

(950mg/10ml) - CALCIUM

SACCHARATE

TETRAHYDRATE

(36mg/10ml)

Box x 10

ampoules x

10ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

422/11.07.2013 3.5

213

CALCIO

CLORURO

MONICO

Concentrate for

solution for infusion

x 1g/10ml CALCIUM CHLORIDE

Box x 5

ampoules x

10ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

422/11.07.2013 1.8

214

AMINOFILLINA

MONICO

Concentrate for

solution for IV

injection x

240mg/10ml AMINOPHYLLINE

Box x 5

ampoules x

10ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

422/11.07.2013 1.8

215

ADRENALINA

MONICO

Solution for

injection x 1mg/ml ADRENALINE

Box x 10

ampoules x 1ml MONICO SPA - ITALI MONICO SPA - ITALI

REGJ

422/11.07.2013 2.8

216

LIDOCAINA

CLORIDRATO

MONICO

Solution for

injection x 10mg/ml

LIDOCAINE

HYDROCHLORIDE

Box x 5

ampoules x 5ml"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

1.5

217

POTASSIO

ASPARTATO

MONICO

Concetrate for

solution for infusion

& for oral solution x

1 mEq/ml

(1.711g/10ml)

d,1-POTASSIUM

ASPARTATE

Box x 10

ampoules

aspartate

"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

3.5

218

SODIO

BICARBONATE

MONICO

Concetrate for

solution for infusion

x 1 mEq/ml

(0.84g/10ml)

SODIUM BICARBONATE

Box x 10

ampoules x

10ml

"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

3.5

219

ELETTROLITICA

BILANCIATA DI

MANTENIMENTO

CON GLUCOSIO

MONICO

Solution for

infusion x (2.34g +

0.98g + 0.316g +

55g)/1000ml

SODIUM CHLORIDE +

POTASSIUM ACETATE +

MAGNESIUM ACETATE

TRIHYDRATE + GLUCOSE

MONOHYDRATE

Glass bottle x

500ml"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

2

Page 25

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26

220

ELETTROLITICA

EQUILIBRATA

PEDIATRICA

MONICO

Solution for

infusion x (1.3g +

0.26g + 0.31g +

3.2g + 55g)/1000ml

POTASSIUM CHLORIDE +

POTASSIUM PHOSPHATE

DIBASIC + MAGNESIUM

CHLORIDE HEXAHYDRATE

+ SODIUM ACETATE

TRIHYDRATE + GLUCOSE

MONOHYDRATE

Glass bottle x

100ml"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

1.6

221

ELETTROLITICA

REIDRATANTE

MONICO

Solution for

infusion x (5g +

0.75g + 0.35g +

0.31g + 6.4g +

0.75g)/1000ml

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE + MAGNESIUM

CHLORIDE HEXAHYDRATE

_ SODIUM ACETATE

TRIHYDRATE + SODIUM

CITRATE DIHYDRATE

Glass bottle x

250ml"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

1

222

ELETTROLITICA

REIDRATANTE

MONICO

Solution for

infusion x (5g +

0.75g + 0.35g +

0.31g + 6.4g +

0.75g)/1000ml

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE + MAGNESIUM

CHLORIDE HEXAHYDRATE

_ SODIUM ACETATE

TRIHYDRATE + SODIUM

CITRATE DIHYDRATE

Glass bottle x

500ml"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.475/09.09.2013

1.3

223 MIOZAC

Solution for

infusion x

250mg/20ml

DOBUTAMIN (as

DOBUTAMIN

HYDROCHLORIDE x

280.28MG)

Box x 1 flacon x

20ml

FISIOPHARMA SRL -

ITALI FISIOPHARMA SRL - ITALI

REGJ.

284/11.05.2009 5.6

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27

224

CLORAMFENICOL

O FISIOPHARMA

Powder and

solvent for solution

for injection x

1g/vial-10ml

CHLORAMPHENICOL (as

CHLORAMPHENICOL

SODIUM SUCCINATE x

1.377g)

Box x 1 vial with

powder + 1

ampoule (water

for injection) x

10ml

FISIOPHARMA SRL -

ITALI FISIOPHARMA SRL - ITALI

REGJ.

575/28.10.2010 3

225 BATIFLOX

Film-coated tablets

x 250mg

LEVOFLOXACINE (as

LEVOFLOXACINE

HEMIHYDRATE x 256.23mg) Box x 5 S.F. GROUP SRL - ITALI

INDOCO REMEDIES LIMITED

- INDI; ZETA ANALYTICAL

LTD - MBRETERI E

BASHKUAR; KENNET

BIOSERVICES LTD -

MBRETERI E BASHKUAR;

MICROBIOLOGICAL

CONSULTANCY SERVICE -

MBRETERI E BASHKUAR;

PSI SUPPLY NV - BELGJIKE;

LA.FA.RE SRL - ITALI;

ASTRON RESEARCH LTD -

MBRETERI E BASHKUAR;

BCM LTD - MBRETERI E

BASHKUAR; JUBILANT LIFE

SCIENCES LIMITED - INDI

REGJ

307/07.05.2013 10

Page 27

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28

226 BATIFLOX

Film-coated tablets

x 500mg

LEVOFLOXACINE (as

LEVOFLOXACINE

HEMIHYDRATE x 512.46mg) Box x 5 S.F. GROUP SRL - ITALI

INDOCO REMEDIES LIMITED

- INDI; ZETA ANALYTICAL

LTD - MBRETERI E

BASHKUAR; KENNET

BIOSERVICES LTD -

MBRETERI E BASHKUAR;

MICROBIOLOGICAL

CONSULTANCY SERVICE -

MBRETERI E BASHKUAR;

PSI SUPPLY NV - BELGJIKE;

LA.FA.RE SRL - ITALI;

ASTRON RESEARCH LTD -

MBRETERI E BASHKUAR;

BCM LTD - MBRETERI E

BASHKUAR; JUBILANT LIFE

SCIENCES LIMITED - INDI

REGJ

307/07.05.2013 16

227 ANTIBACIN

Powder and

solvent for solution

for IV injection x

1000mg/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM

TRISESQUIHYDRATE)

Box x (1 vial + 1

ampoule x 10ml

water for

injection)

ELPEN SA

PHARMACEUTICAL

COMPANY - GREQI DEMO SA - GREQI

REGJ.

309/17.05.2010 4.8

228 TOPISTIN

Solution for

infusion x

200mg/100ml

CIPROFLOXACIN (as

CIPROFLOXACIN LACTATE

x 2.544mg/ml)

Box x 25 plastic

bag (for hospital

use only)

ELPEN

PHARMACEUTICAL CO.

INC. - GREQI

ELPEN PHARMACEUTICAL

CO. INC. - GREQI REGJ. 21/13.01.2011 187.5

229 TOPISTIN

Solution for

infusion x

400mg/200ml

CIPROFLOXACIN (as

CIPROFLOXACIN LACTATE

x 2.544mg/ml)

Box x 16 plastic

bag (for hospital

use only)

ELPEN

PHARMACEUTICAL CO.

INC. - GREQI

ELPEN PHARMACEUTICAL

CO. INC. - GREQI REGJ. 21/13.01.2011 152

230 PENRAZOL

Powder and

solvent for solution

for infusion x

40mg/vial

OMEPRAZOLE (as

OMEPRAZOLE SODIUM x

42.60mg/10ml)

Box x 1 glass

vial + 1 ampoule

solvent x 10ml

ELPEN

PHARMACEUTICAL CO.

INC. - GREQI

ELPEN PHARMACEUTICAL

CO. INC. - GREQI; ANFARM

HELLAS SA - GREQI

REGJ.

188/12.05.2011 4.5

Page 28

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29

231 ZETAGAL

Powder for solution

for injection x 750

mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM x

817 mg) Box x 1 vial

ELPEN

PHARMACEUTICAL CO.

INC. - GREQI DEMO SA - GREQI

REGJ.

715/24.12.2008 2.21

232

MEROBACT

Powder for solution

for infusion x

1g/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 1140mg)

Box x 10 vials

"ELPEN

PHARMACEUTICAL

CO.INC." GREQI

"DEMO SA

PHARMACEUTICALS

INDUSTRY" GREQI

Regj.475/09.09.2013

120

233 CLARIPEN

Granules for oral

suspension x

250mg/5ml CLARITHROMYCIN

Box x flacon x

60ml

ELPEN

PHARMACEUTICAL

CO.INC. - GREQI

ELPEN PHARMACEUTICAL

CO.INC. - GREQI

REGJ

384/17.06.2013 7.8

234

LOSARTAN

TIASAR

Film-coated tablets

x 100mgLOSARTAN POTASSIUM Box x 60

PENTAFARMA -

SOCIEDADE TECNICO-

MEDICINAL, S.A. -

PORTUGALI

WEST PHARMA -

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS, S.A. -

PORTUGALI;

LUSOMEDICAMENTA -

SOCIEDADE TECNICA

FARMACEUTICA, S.A. -

PORTUGALI, ATLANTIC

PHARMA-PRODUCOES

FARMACEUTICAS SA -

PORTUGALI (APL:

PENTAFARMA - SOCIEDADE

TECNICO-MEDICINAL, S.A. -

PORTUGALI)

REGJ.

577/30.10.2009

5

235

PANTOPRAZOL

BRAITER

Gastro-resistant

tablets x 20mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

22.56mg) Box x 60

TECNIMEDE -

SOCIEDADE TECNICO-

MEDICINAL, S.A. -

PORTUGALI

WEST PHARMA -

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS, S.A. -

PORTUGALI; ATLANTIC

PHARMA-PRODUCOES

FARMACEUTICAS SA -

PORTUGALI (APL:

TECNIMEDE - SOCIEDADE

TECNICO-MEDICINAL, S.A. -

PORTUGALI)

REGJ.

577/30.10.2009 8

Page 29

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30

236

PANTOPRAZOL

BRAITER

Gastro-resistant

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.11mg) Box x 60

TECNIMEDE -

SOCIEDADE TECNICO-

MEDICINAL, S.A. -

PORTUGALI

WEST PHARMA -

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS, S.A. -

PORTUGALI; ATLANTIC

PHARMA-PRODUCOES

FARMACEUTICAS SA -

PORTUGALI (APL:

TECNIMEDE - SOCIEDADE

TECNICO-MEDICINAL, S.A. -

PORTUGALI)

REGJ.

577/30.10.2009 10

237

GABAPENTINA

GABAMOX

Film coated tablets

x 600mg GABAPENTIN Box x 60

PENTAFARMA-

SOCIEDADE TECNICO-

MEDICINAL SA -

PORTUGALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI; ATLANTIC

PHARMA-PRODUCOES

FARMACEUTICAS SA -

PORTUGALI (APL:

PENTAFARMA-SOCIEDADE

TECNICO-MEDICINAL SA -

PORTUGALI) REGJ. 58/02.02.2010 11

238

GABAPENTINA

GABAMOX

Film coated tablets

x 800mg GABAPENTIN Box x 60

PENTAFARMA-

SOCIEDADE TECNICO-

MEDICINAL SA -

PORTUGALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI; ATLANTIC

PHARMA-PRODUCOES

FARMACEUTICAS SA -

PORTUGALI (APL:

PENTAFARMA-SOCIEDADE

TECNICO-MEDICINAL SA -

PORTUGALI) REGJ. 58/02.02.2010 12

Page 30

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31

239

PRAVASTATINA

TETRAFARMA Tablets x 10 mg PRAVASTATIN SODIUM

Box x 1 plastic

bottle x 60

TETRAFARMA-

PRODUTOS

FARMACEUTICOS LDA -

PORTUGALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI (APLIKANT:

FARMOZ-SOCIEDADE

TECNICO-MEDICINAL SA -

PORTUGALI)

REGJ.

684/15.12.2008

240

LOSARTAN +

HIDROCLOROTIA

ZIDA COTIASAR

Film-coated tablets

x (50mg + 12.5mg)

LOSARTAN POTASSIUM+

HYDROCHLOROTHIAZIDE Box x 60

PENTAFARMA-

SOCIEDADE TECNICO-

MEDICINAL SA -

PORTUGALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI;

LUSOMEDICAMENTA-

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGALI (APL:

PENTAFARMA-SOCIEDADE

TECNICO-MEDICINAL SA -

PORTUGALI)

REGJ.

575/28.10.2010 4

241

LOSARTAN +

HIDROCLOROTIA

ZIDA COTIASAR

Film-coated tablets

x (100mg + 25mg)

LOSARTAN POTASSIUM+

HYDROCHLOROTHIAZIDE Box x 28

PENTAFARMA-

SOCIEDADE TECNICO-

MEDICINAL SA -

PORTUGALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI;

LUSOMEDICAMENTA-

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGALI (APL:

PENTAFARMA-SOCIEDADE

TECNICO-MEDICINAL SA -

PORTUGALI)

REGJ.

575/28.10.2010 5

Page 31

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32

242

LOSARTAN +

HIDROCLOROTIA

ZIDA COTIASAR

Film-coated tablets

x (100mg +

12.5mg)

LOSARTAN POTASSIUM+

HYDROCHLOROTHIAZIDE Box x 28

PENTAFARMA-

SOCIEDADE TECNICO-

MEDICINAL SA -

PORTUGALI

WEST PHARMA-

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS SA -

PORTUGALI; ATLANTIC

PHARMA-PRODUCOES

FARMACEUTICAS SA -

PORTUGALI (APL:

PENTAFARMA-SOCIEDADE

TECNICO-MEDICINAL SA -

PORTUGALI)

REGJ.

575/28.10.2010 5

243

TOPIRAMATO

TOMIX

Film coated tablets

x 200mg TOPIRAMATE Box x 60

PENTAFARMA -

SOCIEDADE TECNICO-

MEDICINAL, S.A. -

PORTUGALI

WEST PHARMA -

PRODUCOES DE

ESPECIALIDADES

FARMACEUTICAS, S.A. -

PORTUGALI; (APL:

PENTAFARMA - SOCIEDADE

TECNICO-MEDICINAL, S.A. -

PORTUGALI)

REGJ.

577/30.10.2009 18

244 ADENURIC

Film - coated

tablets x 80mg FEBUXOSTAT Box x 28

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA -

LUKSEMBURG

PATHEON FRANCE -

FRANCE; MENARINI-VON

HEYDEN GMBH - GJERMANI

REGJ

418/12.10.2011 28.28

245 BERLIPRIL PLUS

Tablets x (10mg +

25mg)

ENALAPRIL MALEATE +

HYDROCHLOROTHIAZIDE Box x 30

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI

RIREGJ

282/07.07.2011 5.5

246 BERLOCID 960

Tablets x (160mg +

800mg)

TRIMETHOPRIM +

SULPHAMETHOXAZOLE Box x 20

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI; MENARINI-VON

HEYDEN GMBH - GJERMANI

RIREGJ.

647/10.12.2010 2.42

Page 32

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33

247

ESPUMISAN

PERLEN

Soft capsules x

40mg SIMETHICONE Box x 25

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI; R.P. SCHERER

GMBH & CO.KG - GJERMANI;

MENARINI - VON HEYDEN

HMBH - GJERMANI

RIREGJ.

676/31.12.2010 1.8

248 EUDORLIN

Oral suspension x

20mg/ml IBUPROFEN

Box x bottle x

100ml

BERLIN-CHEMIE AG -

GJERMANI

FARMASIERRA

MANUFACTURING SL -

SPANJE

REGJ

596/26.11.2012 2.3

249 FASTUM Gel x 2.5% KETOPROFEN x 2.5g/100g

Box x 1 tube x

50g

A. MENARINI INDUSTRIE

FARMACEUTICHE

RIUNITE S.R.L. - ITALI

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

S.R.L. - ITALI

RIREGJ.

96/16.03.2011 2.45

250 FLAVAMED Tablets x 30mg

AMBROXOL

HYDROCHLORIDE Box x 20

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI; MENARINI-VON

HEYDEN GMBH - GJERMANI

RIREGJ.

647/10.12.2010 1.68

251 FLAVAMED

Oral solution x

0.3g/100ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 100ml

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI

RIREGJ.

647/10.12.2010 2.07

252 JODOX Tablets x 200µg

POTASSIUM IODIDE X

0.262MG Box x 50

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI; MENARINI-VON

HEYDEN GMBH - GJERMANI

RIREGJ.

155/20.04.2011 2.7

253 LERCANIL 20

Film-coated tablets

x 20mg

LERCANIDIPINE

HYDROCHLORIDE

(EQUIVALENT TO 18.8MG

LERCANIDIPINE) Box x 28

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI

RIREGJ.

291/06.05.2010 14.34

254 LERCANIL ACE

Film - coated

tablets x (10mg +

10mg)

ENALAPRIL MALEATE

(corresp. to 7.64mg

ENALAPRIL) +

LERCANIDIPINE

HYDROCHLORIDE (corresp.

to 9.44mg LERCANIDIPINE) Box x 28

RECORDATI INDUSTRIA

CHIMICA

FARMACEUTICA SPA -

ITALI

RECORDATI INDUSTRIA

CHIMICA FARMACEUTICA

SPA - ITALI (APL: MERCKLE

RECORDATI GMBH -

GJERMANI)

REGJ

420/13.10.2011 13.66

Page 33

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34

255 LERCANIL ACE

Film - coated

tablets x (20mg +

10mg)

ENALAPRIL MALEATE

(corresp. to 15.29mg

ENALAPRIL) +

LERCANIDIPINE

HYDROCHLORIDE (corresp.

to 9.44mg LERCANIDIPINE) Box x 28

RECORDATI INDUSTRIA

CHIMICA

FARMACEUTICA SPA -

ITALI

RECORDATI INDUSTRIA

CHIMICA FARMACEUTICA

SPA - ITALI (APL: MERCKLE

RECORDATI GMBH -

GJERMANI)

REGJ

420/13.10.2011 13.66

256 LIOTON Gel x 1000 I.U./1g HEPARIN SODIUM

Box x 1 tube x

50g

A.MENARINI INDUSTRIE

FARMACEUTICHE

RIUNITE S.R.L." - ITALI

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

S.R.L. - ITALI

RIREGJ.

81/5.02.2009 5

257 MEZYM F

Gastro - resistant

film - coated tablets

x 125mg

PANCREATIN (PORCINE

PANCREAS POWDER) EQ.

TO MINIMUM ACTIVITY OF:

MINIMUM LIPOLYTIC

ACTIVITY 10.000 Ph.Eur.U.;

MINIMUM AMILOLYTIC

ACTIVITY 7.500 Ph.Eur.U;

MINIMUM TOTAL

PROTEOLYTIC ACTIVITY

375 Ph.Eur.u Box x 20

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI; MENARINI-VON

HEYDEN GMBH - GJERMANI

REGJ

420/13.10.2011 2.4

258

NEBILET PLUS

5/12.5

Film-coated tablets

x (5mg + 12.5mg)

NEBIVOLOL (as

NEBIVOLOL

HYDROCHLORIDE x

5.45mg) +

HYDROCHLOROTHIAZIDE Box x 28

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA -

LUKSEMBURG

MENARINI INTERNATIONAL

OPERATIONS

LUXEMBOURG SA -

LUKSEMBURG; BERLIN

CHEMIE AG - GJERMANI

REGJ.

575/28.10.2010 15.87

259

NEBILET PLUS

5/25

Film-coated tablets

x (5mg + 25mg)

NEBIVOLOL (as

NEBIVOLOL

HYDROCHLORIDE x

5.45mg) +

HYDROCHLOROTHIAZIDE Box x 28

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA -

LUKSEMBURG

MENARINI INTERNATIONAL

OPERATIONS

LUXEMBOURG SA -

LUKSEMBURG; BERLIN

CHEMIE AG - GJERMANI

REGJ.

575/28.10.2010 15.87

Page 34

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35

260 NIXAR Tablets x 20mg BILASTINE Box x 10

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA -

LUKSEMBURG

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

S.R.L. - ITALI; FAES FARMA

SA - SPANJE; MENARINI-

VON HEYDEN GMBH -

GJERMANI; (APL: BERLIN-

CHEMIE AG - GJERMANI) REGJ 3/07.01.2013 2.5

261 OLTAR 1 Tablets x 1mg GLIMEPIRIDE Box x 30

BERLIN-CHEMIE AG -

GJERMANI

USV LIMITED - INDI;

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

SRL - ITALI

RIREGJ

266/19.04.2013 1.99

262 OLTAR 2 Tablets x 2mg GLIMEPIRIDE Box x 30

BERLIN-CHEMIE AG -

GJERMANI

USV LIMITED - INDI;

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

SRL - ITALI

RIREGJ

266/19.04.2013 3.99

263 OLTAR 3 Tablets x 3mg GLIMEPIRIDE Box x 30

BERLIN-CHEMIE AG -

GJERMANI

USV LIMITED - INDI;

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

SRL - ITALI

RIREGJ

266/19.04.2013 4.97

264 RANEXA

Prolonged-release

tablets x 375mg RANOLAZINE Box x 60

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA (MIOL)

- LUKSEMBURG

DSM PHARMACEUTICALS

INC - SHBA; FINE FOODS

NTM SPA - ITALI; MENARINI-

VON HEYDEN GMBH -

GJERMANI; BERLIN-CHEMIE

AG - GJERMANI

REGJ.

433/29.07.2010 58.51

Page 35

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36

265 RANEXA

Prolonged-release

tablets x 500mg RANOLAZINE Box x 60

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA (MIOL)

- LUKSEMBURG

DSM PHARMACEUTICALS

INC - SHBA; FINE FOODS

NTM SPA - ITALI; MENARINI-

VON HEYDEN GMBH -

GJERMANI; BERLIN-CHEMIE

AG - GJERMANI

REGJ.

433/29.07.2010 58.51

266 RANEXA

Prolonged-release

tablets x 750mg RANOLAZINE Box x 60

MENARINI

INTERNATIONAL

OPERATIONS

LUXEMBOURG SA (MIOL)

- LUKSEMBURG

DSM PHARMACEUTICALS

INC - SHBA; FINE FOODS

NTM SPA - ITALI; MENARINI-

VON HEYDEN GMBH -

GJERMANI; BERLIN-CHEMIE

AG - GJERMANI

REGJ.

433/29.07.2010 58.51

267 SPASMOMEN

Coated tablets x

40mg OTILONIUM BROMIDE Box x 30

A.MENARINI INDUSTRIE

FARMACEUTICHE

RIUNITE S.R.L." - ITALI

BERLIN CHEMIE AG -

GJERMANI,A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

S.R.L. - ITALI

RIREGJ.

81/5.02.2009 6.79

268

TRIFAS 10

AMPOULES

Solution for

injection x

10mg/2ml

TORASEMIDE (as

TORASEMIDE SODIUM x

10.631mg/2ml)

Box x 5

ampoules x 2ml

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI, A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

SRL - ITALI

RIREGJ.

235/07.06.2011 2.47

269 TRIFAS 10 Tablets x 10mg TORASEMIDE Box x 30

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI

RIREGJ

297/18.07.2011 6.9

270 ZOSTEX Tablets x 125mg BRIVUDINE Box x 7

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI

RIREGJ

266/12.06.2012 62

271 XILOX

Granules for oral

suspension x

100mg/sachet NIMESULIDE

Box x 30

sachets

LABORATORI GUIDOTTI

SPA - ITALI

LABORATORIOS MENARINI

SA - SPANJE; FINE FOODS

N.T.M.SPA - ITALI (APL:

BERLIN-

CHEMIE/A.MENARINI KFT -

HUNGARI)

REGJ

420/13.10.2011 6

Page 36

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37

272 ZOFECARD

Film-coated tablets

x 30mg

ZOFENOPRIL CALCIUM

(eq. To 28.7mg

ZOFENOPRIL) Box x 28

BERLIN-CHEMIE AG

(MENARINI GROUP) -

GJERMANI

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

S.R.L. - ITALI (APL: BERLIN

CHEMIE/A.MENARINI KFT -

HUNGARI)

RIREGJ

46/30.01.2012 8.05

273 ZOFECARD

Film-coated tablets

x 7.5mg

ZOFENOPRIL CALCIUM

(eq. To 7.2mg

ZOFENOPRIL) Box x 28

BERLIN-CHEMIE AG

(MENARINI GROUP) -

GJERMANI

A.MENARINI

MANUFACTURING

LOGISTICS AND SERVICES

S.R.L. - ITALI (APL: BERLIN

CHEMIE/A.MENARINI KFT -

HUNGARI)

RIREGJ

46/30.01.2012 8.05

274 SILVEDERMA Cream x 1g/100g SILVER SULPHADIAZINE

Box x 1 tube x

50g

LABORATORIO ALDO

UNION SA - SPANJE

LABORATORIO ALDO UNION

SA - SPANJE

REGJ

526/23.12.2011 3

275

SILVEDERMA

AEROSOL

Cutaneous spray,

suspension x

10mg/ml SILVER SULPHADIAZINE

Box x 1

aluminium

monobloc bottle

x 50ml

LABORATORIO ALDO

UNION SA - SPANJE

LABORATORIO ALDO UNION

SA - SPANJE

REGJ

526/23.12.2011 5

276 BETADERM Cream x 0.1 %

BETAMETHASONE (as

BETAMETHASONE

VALERATE)

Box x tube x 20

g

EGYPTIAN

INTERNATIONAL

PHARMACEUTICAL

INDUSTRIES Co. A.R.E.

(E.I.P.I.C.O.) - EGJIPT (e

regjistruar ne Rumani)

EGYPTIAN INTERNATIONAL

PHARMACEUTICAL

INDUSTRIES Co. A.R.E.

(E.I.P.I.C.O.) - EGJIPT

REGJ.

619/05.11.2008 1.75

277 BETADERM Ointment x 0.1 %

BETAMETHASONE (as

BETAMETHASONE

VALERATE)

Box x tube x 20

g

EGYPTIAN

INTERNATIONAL

PHARMACEUTICAL

INDUSTRIES Co. A.R.E.

(E.I.P.I.C.O.) - EGJIPT (e

regjistruar ne Rumani)

EGYPTIAN INTERNATIONAL

PHARMACEUTICAL

INDUSTRIES Co. A.R.E.

(E.I.P.I.C.O.) - EGJIPT

REGJ.

619/05.11.2008 1.75

Page 37

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38

278 EPICOZYM

Syrup x (5mg +

2mg + 2mg + 20mg

+ 3mg) / 5ml

THIAMINE

HYDROCHLORIDE +

RIBOFLAVINE (as

RIBOFLAVINE SODIUM

PHOSPHATE DIHYDRATE)

+ PYRIDOXINE

HYDROCHLORIDE +

NICOTINAMIDE + D-

PANTHENOL

Box x 1 glass

bottle x 125ml

EGYPTIAN

INTERNATIONAL

PHARMACEUTICAL

INDUSTRIES CO.

(EIPICO.) - EGJIPT (e

regjistruar ne Rumani)

EGYPTIAN INTERNATIONAL

PHARMACEUTICAL

INDUSTRIES CO. (EIPICO.) -

EGJIPT

REGJ.

534/15.10.2009 2.1

279 CEBROTONIN

Film-coated tablets

x 800mg PIRACETAM Box x 30

WALTER RITTER GMBH

+ CO. KG - GJERMANI

ARTESAN PHARMA GMBH &

CO. KG - GJERMANI

RIREGJ.

291/06.05.2010 4.7

280 BIOTUM

Powder for solution

for injection or

infusion x 1g/vial CEFTAZIDIME Box x 1 vial

PHARMACEUTICAL

WORKS POLPHARMA SA

- POLONI BIOTON SA - POLONI

REGJ.

292/06.05.2010 2.6

281 BIOTUM

Powder for solution

for injection or

infusion x 2g/vial CEFTAZIDIME Box x 1 vial

PHARMACEUTICAL

WORKS POLPHARMA SA

- POLONI BIOTON SA - POLONI

REGJ.

292/06.05.2010 6

282 BIOTRAKSON

Powder for solution

for injection x

1g/vial CEFTRIAXONE Box x 1 vial

PHARMACEUTICAL

WORKS POLPHARMA SA

- POLONI BIOTON SA - POLONI

REGJ.

292/06.05.2010 1.3

283 BIOTRAKSON

Powder for solution

for injection or

infusion x 2g/vial CEFTRIAXONE Box x 1 vial

PHARMACEUTICAL

WORKS POLPHARMA SA

- POLONI BIOTON SA - POLONI

REGJ.

292/06.05.2010 5

284 BIOFAZOLIN

Powder for solution

for injection x

1g/vial CEFAZOLIN Box x 1 vial

PHARMACEUTICAL

WORKS POLPHARMA

S.A - POLONI

PHARMACEUTICAL WORKS

POLPHARMA S.A - POLONI

REGJ

359/28.05.2013 1.2

285

MEMOTROPIL

20%

Solution for

injection x 1g/5ml PIRACETAM

Box x 12

ampoules

PHARMACEUTICAL

WORKS POLPHARMA

S.A - POLONI

PHARMACEUTICAL WORKS

POLPHARMA S.A - POLONI

REGJ

359/28.05.2013 18

Page 38

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39

286 METAFENEX

Tablets x (200mg +

325mg)

IBUPROFEN +

PARACETAMOL Box x 20 tabs

PHARMACEUTICAL

WORKS POLPHARMA

S.A - POLONI

ZAKLADY

FARMACEUTYCZNE POLFA-

LODZ SPOLKA AKCYJNA -

POLONI

REGJ

359/28.05.2013 2.5

287 BIOFUROKSYM

Powder for solution

for injection x 750

mg/vial CEFUROXIME

Box x 1 glass

vial

PHARMACEUTICAL

WORKS POLPHARMA SA

- POLONI

PHARMACEUTICAL WORKS

POLPHARMA SA - POLONI

REGJ

140/19.03.2013 1.8

288 BIOFUROKSYM

Powder for solution

for injection x

1.5g/vial CEFUROXIME

Box x 1 glass

vial

PHARMACEUTICAL

WORKS POLPHARMA SA

- POLONI

PHARMACEUTICAL WORKS

POLPHARMA SA - POLONI

REGJ

140/19.03.2013 2.4

289 COLOMYCIN

Powder for

injection x 1 000

000 I.U./vial COLISTIMETHATE SODIUM Box x 10 Vials

FOREST LABORATORIES

UK LIMITED - MBRETERI

E BASHKUAR

FOREST LABORATORIES UK

LIMITED - MBRETERI E

BASHKUAR; ALPHARMA APS

- DANIMARKE

REGJ.

620/05.11.2008 60

290 BICALUTAMIDE

Film-coated tablets

x 50mg BICALUTAMIDE Box x 30

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR; INTAS

PHARMACEUTICALS

LIMITED - INDI

REGJ.

575/28.10.2010 80

291

IRINOTECAN

HYDROCHLORIDE

Concentrate for

solution for infusion

x 20mg/ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE

Box x 1 glass

vial x 5ml

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR; INTAS

PHARMACEUTICALS

LIMITED - INDI

REGJ.

588/29.10.2010 120

292 GEMCITABINE

Powder for solution

for infusion x

200mg/vial

GEMCITABINE (as

GEMCITABINE

HYDROCHLORIDE x

45.54mg/ml)

Box x 1 glass

vial

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR; INTAS

PHARMACEUTICALS

LIMITED - INDI

REGJ.

588/29.10.2010 50

293 GEMCITABINE

Powder for solution

for infusion x

1g/vial

GEMCITABINE (as

GEMCITABINE

HYDROCHLORIDE x

45.54mg/ml)

Box x 1 glass

vial

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR

ACCORD HEALTHCARE

LIMITED - MBRETERI E

BASHKUAR; INTAS

PHARMACEUTICALS

LIMITED - INDI

REGJ.

588/29.10.2010 120

Page 39

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40

294

LACTATED

RINGER'S

INJECTION/VIOSE

R

Solution for

infusion x (6g +

0.3g + 0.2g +

6.2g)/1000ml

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE + SODIUM

LACTATE SOLUTION 50%

Box x Plastic

bottle x 250ml

(for hospital use

only) VIOSER SA - GREQI VIOSER SA - GREQI

REGJ

297/25.06.2012 0.66

295

SODIUM

CHLORIDE/VIOSE

R

Solution for

infusion x 0.9%

(w/v) SODIUM CHLORIDE

Box x Plastic

bottle x 250ml

(for hospital use

only) VIOSER SA - GREQI VIOSER SA - GREQI

REGJ

297/25.06.2012 0.64

296

SODIUM

CHLORIDE/VIOSE

R

Solution for

infusion x 0.9%

(w/v) SODIUM CHLORIDE

Box x Plastic

bottle x 100ml

(for hospital use

only) VIOSER SA - GREQI VIOSER SA - GREQI

REGJ

297/25.06.2012 0.64

297

DEXTROSE/VIOSE

R

Solution for

infusion x 5% (w/v)

DEXTROSE ANHYDROUS

(as DEXTROSE (GLUCOSE)

MONOHYDRATE X

5.5G/100ML)

Box x Plastic

bottle x 250ml

(for hospital use

only)

VIOSER SA - GREQI VIOSER SA - GREQIREGJ.

297/25.06.2012

0.69

298

DEXTROSE/VIOSE

R

Solution for

infusion x 5% (w/v)

DEXTROSE ANHYDROUS

(as DEXTROSE (GLUCOSE)

MONOHYDRATE X

5.5G/100ML)

Box x Plastic

bottle x 100ml

(for hospital use

only)

VIOSER SA - GREQI VIOSER SA - GREQIREGJ.

297/25.06.2012

0.69

299

MANNITOL/VIOSE

R

Solution for

infusion x

200mg/ml MANNITOL

Box x 10

polyethylene

bottles x 250ml VIOSER SA - GREQI VIOSER SA - GREQI

REGJ

359/28.05.2013 13.9

300 TAZEPEN

Powder for solution

for injection x (2 +

0.25)g/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

2.085g/vial) +

TAZOBACTAM (as

TAZOBACTAM SODIUM x

0.2683g/vial)

Box x 1 glass

vial ENORASIS SA - GREQI

LABORATORIO

FARMACEUTICO CT SRL -

ITALI; ELPEN

PHARMACEUTICALS SA -

GREQI

REGJ.

188/12.05.2011 8

Page 40

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41

301 TAZEPEN

Powder for solution

for injection x (4 +

0.5)g/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

4.170g/vial) +

TAZOBACTAM (as

TAZOBACTAM SODIUM x

0.5366g/vial)

Box x 1 glass

vial ENORASIS SA - GREQI

LABORATORIO

FARMACEUTICO CT SRL -

ITALI; ELPEN

PHARMACEUTICALS SA -

GREQI

REGJ.

188/12.05.2011 13

302 ZOLENAT

Concentrate for

solution for IV

infusion x 4mg/5ml

ZOLEDRONIC ACID (as

ZOLEDRONIC ACID

MONOHYDRATE x

4.264mg/vial) Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

526/23.12.2011 200

303 PREDNOL Tablets x 4mg METHYLPREDNISOLONE Box x 20

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

526/23.12.2011 1.8

304 PREDNOL Tablets x 16mg METHYLPREDNISOLONE Box x 20

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

526/23.12.2011 4.2

305 OKSAMEN

Film-coated tablets

x 20mg TENOXICAM Box x 10

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

526/23.12.2011 3.9

306 OKSAMEN - L

Powder for solution

for IM/IV injection x

20 mg/vial TENOXICAM

Box x 1 vial of

freeze-dried

powder + 1

ampoule of

diluent (water

for injection) x

2ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 1.7

307 IDAMEN

Solution for I.V

injection x 5mg/5ml

IDARUBICIN

HYDROCHLORIDE Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 90

308 IDAMEN

Solution for I.V

injection x

10mg/10ml

IDARUBICIN

HYDROCHLORIDE Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 150

309 IDAMEN

Solution for I.V

injection x

20mg/20ml

IDARUBICIN

HYDROCHLORIDE Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 200

310 TEKAMEN

Solution for IV

infusion x

100mg/5ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 84

Page 41

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42

311 TEKAMEN

Solution for IV

infusion x

40mg/2ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 70

312 PREDNOL - L

Powder for solution

for IM/IV injection x

20 mg/vial

METHYLPREDNISOLONE

(as

METHYLPREDNISOLONE

SODIUM SUCCINATE x

26.5mg/vial)

Box x 1 vial of

freeze-dried

powder + 1

ampoule of

diluent (water

for injection) x

2ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 0.95

313 PREDNOL - L

Powder for solution

for IM/IV injection x

40 mg/vial

METHYLPREDNISOLONE

(as

METHYLPREDNISOLONE

SODIUM SUCCINATE

x53mg/vial)

Box x 1 vial of

freeze-dried

powder + 1

ampoule of

diluent (water

for injection) x

2ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 1.1

314 PREDNOL - L

Powder for solution

for IM/IV injection x

250 mg/vial

METHYLPREDNISOLONE

SODIUM SUCCINATE

Box x 1 vial of

freeze-dried

powder + 1

ampoule of

diluent (water

for injection) x

4ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

REGJ

527/23.12.2011 3.7

315 KLOVIREKS - L

Lyophilised powder

for solution for IV

injection x

250mg/vial ACYCLOVIR Box x 1 vial

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

46/30.01.2012 3.4

316 LUMEN 100

Solution for IV

injection x

100mg/50ml FLUCONAZOLE

Box x 1 flacon x

50ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

46/30.01.2012 2.3

Page 42

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43

317 UNISEF

Powder and

solvent for solution

for injection x

1g/vial

CEFEPIME (as CEFEPIME

DIHYDROCHLORIDE

MONOHYDRATE x 1189.16

mg/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent

(sterilised water

for injection) x

10ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

46/30.01.2012 10

318 BETAKSIM

Powder and

solvent for solution

for injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1048mg/vial)

Box x 1 vial

(powder) + 1

ampoule x 4ml

solvent (water

for injection)

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

75/17.02.2012 2.5

319 MULTISEF

Powder and

solvent for solution

for injection x

750mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM x

789mg/vial)

Box x 1 glass

vial + 1 ampoule

x 6ml solvent

(water for

injection)

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

75/17.02.2012 2

320 NEVPARIN

Solution for I.V

injection x 25000

IU/5ml HEPARIN SODIUM

Box x 1 vial x

5ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

105/06.03.2012 5

321 SEFAZOL 1G

Powder and

solvent for solution

for injection x

1g/vial

CEFAZOLIN (as

CEFAZOLIN SODIUM x

1.048mg/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent x 4ml

(water for

injection)

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

105/06.03.2012 0.82

322 UNIKLAR

Granules for oral

suspension x

250mg/5ml CLARITHROMYCIN

Box x 1 bottle x

50ml

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

167/19.04.2012 5

323 NEVAKSON

Powder and

solvent for solution

for I.V. injection x

1g/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM X

1193mg/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent x 10ml

(water for

injection)

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

MUSTAFA NEVZAT ILAC

SANAYII AS - TURQI

RIREGJ

167/19.04.2012 1.5

Page 43

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44

324

ACC AKUT

600MG

Effervescent

tablets x 600mg ACETYLCYSTEINE Box x 10 HEXAL AG -GJERMANI

HERMES ARZNEIMITTEL

GMBH - GJERMANI

REGJ.

222/08.04.2009 2.3

325 ACC 200

Effervescent

tablets x 200mg ACETYLCYSTEINE Box x 50 HEXAL AG -GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, SALUTAS PWO

GMBH - GJERMANI,

HERMES PHARMA

GES.M.B.H. - AUSTRI

REGJ.

222/08.04.2009 6.4

326

ACC AKUT

JUNIOR

Granules for oral

solution x

100mg/5ml ACETYLCYSTEINE

Box x bottle x

75ml HEXAL AG -GJERMANI

ALLPHAMED PHARBIL

ARZNEIMITTEL GMBH -

GJERMANI; SALUTAS

PHARMA GMBH-BARLEBEN -

GJERMANI

REGJ.

222/08.04.2009 2.8

327 ACC 200

Powder for oral

solution x

200mg/sachet ACETYLCYSTEINE

Box x 20

sachets HEXAL AG -GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, LINDOPHARM

GMBH - GJERMANI

REGJ.

222/08.04.2009 2

328 AZITROMICIN LEK

Film-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

MONOHYDRATE) Box x 3

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; S.C. SANDOZ

SRL - RUMANI

RIREGJ

597/26.11.2012 4.5

329 LEKOTAM Tablets x 1.5mg BROMAZEPAM Box x 30

LEK PHARMACEUTICALS

D.D - SLLOVENI

LEK PHARMACEUTICALS

D.D - SLLOVENI

RIREGJ.

269/28.04.2010 0.7

330 LENDACIN

Powder for solution

for

injection/infusion x

2g/vial

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM

3.5 HYDRATE x

2386.6mg/vial)

Box x 10 vials

(for hospital use

only)

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE SANDOZ GMBH - AUSTRI

RIREGJ

190/27.04.2012 23

331 LENDACIN

Powder for solution

for

injection/infusion x

1g/vial

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM

3.5 HYDRATE x

1193.3mg/vial) Box x 1 vial

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE SANDOZ GMBH - AUSTRI

RIREGJ

190/27.04.2012 1.5

332 LENDACIN

Powder for solution

for

injection/infusion x

1g/vial

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM

3.5 HYDRATE x

1193.3mg/vial)

Box x 10 vials

(for hospital use

only)LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE SANDOZ GMBH - AUSTRI

RIREGJ

190/27.04.2012 12.5

Page 44

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45

333 LENDACIN

Powder for solution

for injection x

500mg/vial

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM

3.5 HYDRATE x

596.7mg/vial)

Box x 10 vials

(for hospital use

only)

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE SANDOZ GMBH - AUSTRI

RIREGJ

190/27.04.2012 8.5

334 LEKOKLAR

Granules for oral

suspension x 125

mg/5 ml CLARITHROMYCIN

Box x 1 flacon x

60 ml

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

S.C. SANDOZ S.R.L. -

RUMANI

REGJ.

714/24.12.2008 4

335 LEKOKLAR

Granules for oral

suspension x 250

mg/5 ml CLARITHROMYCIN

Box x 1 flacon x

60 ml

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

S.C. SANDOZ S.R.L. -

RUMANI

REGJ.

714/24.12.2008 5.7

336 KETONAL 2.5% Gel x 25mg/1g KETOPROFEN

Box x 1 tube x

50g

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS

D.D - SLLOVENI; SALUTAS

PHARMA GMBH - GJERMANI

RIREGJ.

78/11.02.2010 2.44

337 KETONAL Cream x 5% (w/w) KETOPROFEN

Box x 1 tube x

30g

LEK SKOPJE DOOEL-

SKOPJE - MAQEDONI

SALUTAS PHARMA GMBH -

GJERMANI; LEK

PHARMACEUTICALS DD -

SLLOVENI

RIREGJ

334/20.05.2013 1.58

338 PIRAMIL Tablets x 5mg RAMIPRIL Box x 28

LEK SKOPJE DOOEL -

MAQEDONI

LEK SA - POLONI (APL: LEK

SA - POLONI)

RIREGJ.

291/06.05.2010 3

339 PIRAMIL Tablets x 10mg RAMIPRIL Box x 28

LEK SKOPJE DOOEL -

MAQEDONI

LEK SA - POLONI (APL: LEK

SA - POLONI)

RIREGJ.

291/06.05.2010 4.7

340 PIRAMIL H

Tablets x (5mg +

25mg)

RAMIPRIL +

HYDROCHLOROTHIAZIDE Box x 28

LEK SKOPJE DOOEL-

SKOPJE - MAQEDONI

SALUTAS PHARMA GMBH -

GJERMANI; LEK

PHARMACEUTICALS DD -

SLLOVENI; HEXAL AG -

GJERMANI

RIREGJ

325/15.05.2013 6.8

341 SERTIVA

Film coated tablets

x 50mg

SERTRALINE (as

SERTRALINE

HYDROCHLORIDE x

55.95mg) Box x 28 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, HEXAL A/S -

DANIMARKE, SANDOZ ILAC

SANAYII VE TICARET A.S. -

TURQI

REGJ.

284/11.05.2009 3.8

Page 45

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46

342 OPERIL P

Nasal spray,

solution x

0.25mg/ml

OXYMETAZOLINE

HYDROCHLORIDE EQ. TO

0.22mg OXYMETAZOLINE

Box x 1 plastic

bottle x 10ml

LEK PHARMACEUTICALS

D.D - SLLOVENI

LEK PHARMACEUTICALS

D.D - SLLOVENI

RIREGJ.

584/29.10.2010 2.4

343 OPERIL

Nasal spray,

solution x 0.5mg/ml

OXYMETAZOLINE

HYDROCHLORIDE EQ. TO

0.44mg OXYMETAZOLINE

Box x 1 plastic

bottle x 10ml

LEK PHARMACEUTICALS

D.D - SLLOVENI

LEK PHARMACEUTICALS

D.D - SLLOVENI

RIREGJ.

584/29.10.2010 2.76

344 XORIMAX

Coated tablets x

250mg

CEFUROXIME CORRESP.

TO 300.72mg CEFUROXIME

AXETIL Box x 10

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

SANDOZ GMBH - AUSTRI;

PENCEF PHARMA GMBH -

GJERMANI

RIREGJ.

584/29.10.2010 4

345 XORIMAX

Coated tablets x

500mg

CEFUROXIME CORRESP.

TO 601.44mg CEFUROXIME

AXETIL Box x 10

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

SANDOZ GMBH - AUSTRI;

PENCEF PHARMA GMBH -

GJERMANI

RIREGJ.

584/29.10.2010 6.5

346 KETONAL

Solution for

injection x

100mg/2ml KETOPROFEN

Box x 10

ampoules x 2ml

LEK SKOPJE DOOEL -

MAQEDONI

LEK PHARMACEUTICALS

D.D - SLLOVENI

RIREGJ.

583/29.10.2010 2

347 NILAR

Gastro-resistant

tablets x 20mg

ESOMEPRAZOLE (in the

form of ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

22.045mg) Box x 14

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; LEK SA -

POLONI; SALUTAS PHARMA

GMBH - GJERMANI

REGJ.

580/29.10.2010 5.3

348 NILAR

Gastro-resistant

tablets x 40mg

ESOMEPRAZOLE (in the

form of ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

44.09mg) Box x 14

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; LEK SA -

POLONI; SALUTAS PHARMA

GMBH - GJERMANI

REGJ.

580/29.10.2010 7.1

349 AMYZOL

Film coated tablets

x 10mg

AMITRIPTILLINE

HYDROCHLORIDE Box x 100

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ.

647/10.12.2010 1.97

350 AMYZOL

Film coated tablets

x 10mg

AMITRIPTILLINE

HYDROCHLORIDE Box x 50

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ.

647/10.12.2010 1.25

Page 46

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47

351

LOPEDIUM AKUT

ISO

Effervescent

tablets x 2mg

LOPERAMIDE

HYDROCHLORIDE

Box x 1 tube x

10 HEXAL AG - GJERMANI

HERMES PHARMA

GES.M.B.H. - AUSTRI

REGJ.

664/21.12.2010 1.68

352 CICLORAL HEXAL

Oral solution x

100mg/ml CICLOSPORIN

Box x (1 bottle x

50ml + 1 syringe

+ 1 extraction

top with plastic

tube) HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI

REGJ.

664/21.12.2010 119.5

353 CICLORAL HEXAL

Capsules (soft

coated) x 50mg CICLOSPORIN Box x 50 HEXAL AG - GJERMANI SWISS CAPS AG - ZVICER

REGJ.

664/21.12.2010 65.7

354

TORASEMID

HEXAL Tablets x 5mg TORASEMIDE Box x 30 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, HEXAL AG -

GJERMANI

REGJ.

405/14.07.2009 3.98

355

TORASEMID

HEXAL Tablets x 10mg TORASEMIDE Box x 30 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, HEXAL AG -

GJERMANI

REGJ.

405/14.07.2009 5

356

TORASEMID

HEXAL Tablets x 50mg TORASEMIDE Box x 50 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, HEXAL AG -

GJERMANI

REGJ.

405/14.07.2009 12.65

357

TORASEMID

HEXAL Tablets x 100mg TORASEMIDE Box x 50 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI, HEXAL AG -

GJERMANI

REGJ.

405/14.07.2009 20.24

358 LINEX Capsules x 280mg

LEBENIN POWDER

(12.000.000,00 CFU OF

LYOPHILIZED VIABLE

LACTIC ACID BACTERIA) -

LACTOBACILLUS

ACIDOPHILUS (SP. L.

GASSERI) +

BIFIDOBACTERIUM

INFANTIS +

ENTEROCOCCUS

FAECIUM

Box x 1 glass

bottle x 16

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ.

676/31.12.2010 2.87

359 RANITAL

Solution for

injection x

50mg/2ml

RANITIDINE (AS

RANITIDINE

HYDROCHLORIDE x

55.8mg/2ml)

Box x 5

ampoules x 2ml

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ.

676/31.12.2010 1.9

Page 47

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48

360 ANGAL S

Throat spray,

solution x (2.1mg +

0.5mg)/ml

CHLORHEXIDINE

DIGLUCONATE +

LIDOCAINE

HYDROCHLORIDE

Box x 1 glass

bottle x 30ml

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ.

76/01.03.2011 3.65

361 SANVAL

Film coated tablets

x 10mg

ZOLPIDEM TARTRATE

(corresp. to 8.04 ZOLPIDEM) Box x 20

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS

D.D - SLLOVENI

RIREGJ.

269/28.04.2010 3.4

362 REDERGIN Tablets x 1.5mg

CODERGOCRINE

MESILATE (as

DIHYDROERGOTOXINE

MATHANSULPHONATE) Box x 20

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ

297/18.07.2011 1

363 REDERGIN Tablets x 4.5mg

CODERGOCRINE

MESILATE (as

DIHYDROERGOTOXINE

MATHANSULPHONATE) Box x 20

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE

LEK PHARMACEUTICALS DD

- SLLOVENI

RIREGJ

297/18.07.2011 1.7

364 OPERIL P

Nasal drops,

solution x

0.25mg/ml

OXYMETAZOLINE

HYDROCHLORIDE (corresp.

to 0.22mg/ml of

OXYMETAZOLINE)

Box x 1 plastic

bottle with a

dropper x 10ml

"LEK

PHARMACEUTICALS

D.D" - SLLOVENI

"LEK PHARMACEUTICALS

D.D" - SLLOVENI

RIREGJ

366/23.09.2011 2.4

365 OPERIL

Nasal drops,

solution x 0.5mg/ml

OXYMETAZOLINE

HYDROCHLORIDE (corresp.

to 0.44mg/ml of

OXYMETAZOLINE)

Box x 1 plastic

bottle with a

dropper x 10ml

"LEK

PHARMACEUTICALS

D.D" - SLLOVENI

"LEK PHARMACEUTICALS

D.D" - SLLOVENI

RIREGJ

366/23.09.2011 2.4

366 MODOLEX

Recetal ointment x

(40mg + 20mg)/g

CALCIUM DOBESILATE

MONOHYDRATE +

LIDOCAINE

HYDROCHLORIDE

Box x 1 tube x

30g + applicator

"LEK SKOPJE DOOEL-

SKOPJE" - REPUBLIKA E

MAQEDONISE

"LEK PHARMACEUTICALS

D.D" - SLLOVENI, "SALUTES

PHARMA GMBH" -

GJERMANI

RIREGJ

366/23.09.2011 2.6

367 KUTERID G

Ointment x

0.5mg/g + 1mg/g

BETAMETHASONE AS

BETAMETHASONE

DIPROPIONATE x 0.64mg/g

+ GENTAMICIN AS

GENTAMICIN SULPHATE x

1.66mg/g

Box x 1 tube

15g

"LEK

PHARMACEUTICALS

D.D" - SLLOVENI

"LEK PHARMACEUTICALS

D.D" - SLLOVENI DHE

"SALUTAS PHARMA GMBH" -

GJERMANI

RIREGJ

372/27.09.2011 1.7

Page 48

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49

368 OSPAMOX DT

Dispersible tablets

x 1000mg

AMOXICILLIN (as

AMOXICILLIN

TRIHYDRATE) Box x 14

LEK SKOPJE DOOEL-

SKOPJE - REPUBLIKA E

MAQEDONISE SANDOZ GMBH - AUSTRI

RIREGJ

409/07.10.2011 2.2

369

CITALOPRAM

HEXAL

Film - coated

tablets x 20mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x

24.99mg) Box x 20 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI

REGJ

452/31.10.2011 4

370

CITALOPRAM

HEXAL

Film - coated

tablets x 40mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x

49.98mg) Box x 20 HEXAL AG - GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI

REGJ

452/31.10.2011 7

371 CYNACUR

Coated tablets x

300mg

DRY EXTRACT OF

ARTICHOKE LEAVES (5.8-

7.1 : 1) [EXTRACTION

SOLVENT : WATER] Box x 20 HEXAL AG - GJERMANI

WIEWELHOVE GMBH -

GJERMANI

REGJ

449/31.10.2011 2.45

372 ACIPAN

Gastro - resistant

tablets x 20mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE) Box x 14

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI;SANDOZ ILAC

SANAYI VE TICARET AS -

TURQI; LEK SA - POLONI;

SALUTAS PHARMA GMBH -

GJERMANI

REGJ

449/31.10.2011 3.12

373 ACIPAN

Gastro - resistant

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE) Box x 14

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI;SANDOZ ILAC

SANAYI VE TICARET AS -

TURQI; LEK SA - POLONI;

SALUTAS PHARMA GMBH -

GJERMANI

REGJ

449/31.10.2011 5.79

374 FERRUM LEK

Chewable tablets x

100mg

IRON (as IRON (III) -

HYDROXIDE

POLYMALTOSE COMPLEX) Box x 30

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI

REGJ

449/31.10.2011 3.2

Page 49

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50

375 FERRUM LEK Syrup x 50mg/5ml

IRON (as IRON (III) -

HYDROXIDE

POLYMALTOSE COMPLEX)

Box x 1 bottle x

100ml

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; SANDOZ ILAC

SANAYI VE TICARET A.S. -

TURQI

REGJ

449/31.10.2011 2

376 PERSEN

Coated tablets x

(35mg + 17.5mg +

17.5mg)

VALERIANAE OFFICINALIS

RADICIS EXTR.SICC +

MELISSAE FOLII

EXTR.SICC + MENTHAE

PIPERITAE FOLII EXTR.

SICC Box x 40

LEK SKOPJE DOOEL -

MAQEDONI

LEK PHARMACEUTICALS DD

- SLLOVENI

REGJ

449/31.10.2011 2.4

377 IRON SANDOZ

Concentrate for

solution for infusion

x 100mg/5ml

IRON (III) [as IRON (III)

HYDROXIDE SUCROSE

COMPLEX x 2700mg/5ml]

Box x 5

ampoules x 5ml SANDOZ - FRANCE RAFARM SA - GREQI

REGJ

422/12.09.2012 18.2

378 CANDEA Tablets x 8mg CANDESARTAN CILEXETIL Box x 28

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; LEK SA -

POLONI; SALUTAS PHARMA

GMBH - GJERMANI; LEK D.D.

- SLLOVENI

REGJ

422/12.09.2012 5

379 CANDEA Tablets x 16mg CANDESARTAN CILEXETIL Box x 28

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; LEK SA -

POLONI; SALUTAS PHARMA

GMBH - GJERMANI; LEK D.D.

- SLLOVENI

REGJ

422/12.09.2012 7.5

380 COUPET

Film-coated tablets

x 20mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 20.79mg) Box x 28

LEK PHARMACEUTICALS

D.D - SLLOVENI

LEK PHARMACEUTICALS

D.D - SLLOVENI; SALUTAS

PHARMA GMBH -

GJERMANI; LEK SA -

POLONI

REGJ

422/12.09.2012 10

381

FOROSAFilm coated tablets

x 70mg

ALENDRONIC ACID (eq. to

91.35mg SODIUM

ALENDRONATE)

Box x 4LEK SKOPJE DOOEL -

SKOPJE - MAQEDONI

LEK PHARMACEUTICALS

D.D. - SLLOVENI

REGJ.

422/12.09.20128.8

Page 50

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51

382

LEVOCETIRIZIN

HEXAL

Film coated tablets

x 5mg

LEVOCETIRIZINE

DIHYDROCHLORIDE Box x 20

HEXAL PHARMA GMBH -

AUSTRI

ROTTENDORF PHARMA

GMBH - GJERMANI

REGJ

422/12.09.2012 3.85

383 LINEX FORTE

Capsules x

2.000,00 MIO CFU

LYOPHILIZED VIABLE

LACTIC ACID BACTERIA

[PROBIO-TEC AB 10

POWDER x 60mg:

(LACTOBACILLUS

ACIDOPHILUS 30-70% of

total CFU +

BIFIDOBACTERIUM

ANIMALIS SUBSP. LACTIS

30-70% of total CFU);

TOTAL LACTIC ACID

BACTERIA x 24.36MG] Box x 14

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

(SITE LJUBLJANA) -

SLLOVENI; LEK

PHARMACEUTICALS DD

(SITE MENGES) - SLLOVENI

REGJ

422/12.09.2012 2.2

384 BIVACYN

Cutaneous spray,

powder x (12500

IU + 165000IU) /

150ml

BACITRACIN + NEOMYCIN

(as NEOMYCIN SULPHATE)

Box x 1

pressuruzed

container x

150ml

LEK SKOPJE DOOEL -

SKOPJE - MAQEDONI

LEK PHARMACEUTICALS

D.D. - SLLOVENI; LEK SA -

POLONI; IGS AEROSOLS

GMBH - GJERMANI

REGJ

307/07.05.2013 3.72

385

CALCIUM 500MG

HEXAL

Effervescent

tablets x 500mg

CALCIUM ION (as CALCIUM

CARBONATE x 1250mg) Box x tube x 20 HEXAL AG - GJERMANI

HERMES ARZNEIMITTEL

GMBH - GJERMANI;

HERMES PHARMA GMBH -

AUSTRI

REGJ

61/06.02.2013 3.2

386

TYLOLFEN HOT

PACKET

Powder for oral

solution x (500mg

+ 4mg +

10mg)/packet

PARACETAMOL +

CHLORPHENIRAMINE

MALEATE +

PHENYLEPHRINE

HYDROCHLORIDE

Box x 12

packets

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI REGJ 3/07.01.2013 2.62

387 GLUCOZA 5% m/v

Solution for

infusion x 50g /

1000ml

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Plastic bottle x

500ml

B.BROWN MELSUNGEN

AG - GJERMANI

B.BROWN

PHARMACEUTICALS SA -

RUMANI

RIREGJ.

339/03.06.2009 0.7

388

GLUCOZA 10%

m/v

Solution for

infusion x 100g /

1000ml

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

110g/1000ml)

Plastic bottle x

500ml

B.BROWN MELSUNGEN

AG - GJERMANI

B.BROWN

PHARMACEUTICALS SA -

RUMANI

RIREGJ.

339/03.06.2009 0.86

Page 51

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52

389

CLORURA DE

SODIU 0.9%

Solution for

infusion x 9g /

1000ml SODIUM CHLORIDE

Plastic bottle x

500ml

B.BROWN MELSUNGEN

AG - GJERMANI

B.BROWN

PHARMACEUTICALS SA -

RUMANI

RIREGJ.

339/03.06.2009 0.66

390

SOLUTIE RINGER

LACTAT

Solution for

infusion x (6.0g +

0.4g + 0.27g +

3.12g) / 1000ml

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATES + SODIUM

LACTATE

Plastic bottle x

500ml

B.BROWN MELSUNGEN

AG - GJERMANI

B.BROWN

PHARMACEUTICALS SA -

RUMANI

RIREGJ.

339/03.06.2009

0.68

391 VAXIGRIP

Suspension for

injection in a

prefilled syringe,

inactivated

influenza vaccine

(split virion) x (15μg

+ 15μg +

15μg)/0.5ml

A/BRISBANE/59/2007

(H1N1) - LIKE STRAIN

(A/BRISBANE/59/2007 (IVR-

148), A/BRISBANE/10/2007

(H3N2) - LIKE STRAIN

(A/URUGUAY/716/2007

(NYMC X-175C),

B/BRISBANE/60/2008 - LIKE

STRAIN

B/BRISBANE/60/2008

Box x 1 pre-

filled syringe x

0.5ml

SANOFI PASTEUR S.A -

FRANCE

SANOFI PASTEUR S.A -

FRANCE

RIREGJ.

645/10.12.2010 6

392 ALTERGEN

Cream x (0.2% +

1%) w/w

HYALURONIC ACID

SODIUM SALT + SILVER

SULFADIAZINE

Box x tube x

25g

IBSA FARMACEUTICI

ITALIA SRL - ITALI

IBSA INSTITUT

BIOCHIMIQUE SA - ZVICER;

LABORATOIRES

GENEVRIER SA - FRANCE

RIREGJ

166/19.04.2012 5.66

393 PRONTOGEST

Solution for

injection x

100mg/ml PROGESTERONE

Box x 3

ampoules x 1ml

IBSA FARMACEUTICI

ITALIA SRL - ITALI

IBSA INSTITUT

BIOCHIMIQUE SA - ZVICER;

BIOLOGICI ITALIA

LABORATORIES SRL - ITALI;

SPECIAL PRODUCT'S LINE

SPA - ITALI REGJ 3/07.01.2013 4.5

Page 52

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53

394 ADDAMEL N

Concentrate for

solution for infusion

x (5.33μg + 0.34mg

+ 0.54mg + 99μg +

16.6μg + 0.21mg +

4.85μg + 6.9μg +

1.36mg)/ml

CHROMIC CHLORIDE

(6H2O) + COPPER

CHLORIDE (2H2O) +

FERRIC CHLORIDE (6H2O)

+ MANGANESE CHLORIDE

(4H2O) + POTASSIUM

IODIDE + SODIUM

FLUORIDE + SODIUM

MOLYBDATE (2H2O) +

SODIUM SELENITE

ANHYDROUS + ZINC

CHLORIDE

Box x 20 plastic

ampoules x

10ml

FRESENIUS KABI NORGE

AS - NORVEGJI

FRESENIUS KABI NORGE AS

- NORVEGJI

RIREGJ.

647/10.12.2010 2.86/pc

Page 53

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54

395

KABIVEN

PERIFER

Emulsion for

infusion x [121mg +

200mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 110mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

1440ml

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010

41.36/

pc

Page 54

Page 55: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

55

396

KABIVEN

PERIFER

Emulsion for

infusion x [121mg +

200mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 110mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

1920m

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010 48/pc

Page 55

Page 56: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

56

397

KABIVEN

PERIFER

Emulsion for

infusion x [121mg +

200mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 110mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

2400ml

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010 54.3/pc

Page 56

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57

398 KABIVEN

Emulsion for

infusion x [209mg +

200 mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 190mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

1026ml

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010

40.86/

pc

Page 57

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58

399 KABIVEN

Emulsion for

infusion x [209mg +

200 mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 190mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

1540ml

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010 41.79

Page 58

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59

400 KABIVEN

Emulsion for

infusion x [209mg +

200 mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 190mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

2053ml

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010 50.71

Page 59

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60

401 KABIVEN

Emulsion for

infusion x [209mg +

200 mg + (16mg +

11.3mg + 11.3mg +

8.17mg + 7.9mg +

7.9mg + 7.9mg +

7.3mg + 6.8mg +

6.8mg + 5.97mg +

5.6mg + 5.6mg +

5.6mg + 5.6mg +

5.04mg + 4.5mg +

3.4mg + 3.29mg +

1.6mg + 1.9mg +

980mcg +

230mcg)]/1ml

GLUCOSE MONOHYDRATE

CORRESP. TO GLUCOSE

ANHYDROUS x 190mg +

SOYA-BEAN OIL, REFINED

+ (ALANINE + ARGININE +

LYSINE HCL CORRESP. TO

LYSINE x 9mg + SODIUM

ACETATE TRIHYDRATE

CORRESP. TO SODIUM

ACETATE ANHYDROUS x

4.9mg + GLYCINE +

LEUCINE +

PHENYLALANINE + VALINE

+ HISTIDINE + PROLINE +

POTASSIUM CHLORIDE

(E508) + GLUTAMIC ACID +

ISOLEUCINE +

METHIONINE +

THREONINE + SODIUM

GLYCEROLPHOSPHATE

HYDRATED + SERINE +

ASPARTIC ACID +

MAGNESIUM SULPHATE

HEPTAHYDRATE

CORRESP. TO

MAGNESIUM SULPHATE

ANHYDROUS x 1.6mg +

TRYPTOPHAN + CALCIUM

CHLORIDE DIHYDRATE

CORRESP. TO CALCIUM

CHLORIDE ANHYDROUS x

740mcg + TYROSINE)

Plastic bag x

2566ml

FRESENIUS KABI AB -

SUEDI FRESENIUS KABI AB - SUEDI

RIREGJ.

645/10.12.2010

55.71/

pc

Page 60

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61

402 AMINOVEN 5%

Solution for

infusion x (7.00mg

+ 6.00mg + 5.50mg

+ 1.50mg + 2.50mg

+ 3.70mg + 4.66mg

+ 2.15mg + 2.55mg

+ 5.60mg + 3.25mg

+ 0.50mg + 2.20mg

+ 1,00mg + 0.20mg

+ 3.10mg)/1ml

ALANINE + ARGININE +

GLYCINE + HISTIDINE +

ISOLEUCINE + LEUCINE +

LYSINE ACETATE +

METHIONINE +

PHENYLALANINE +

PROLINE + SERINE +

TAURINE + THREONINE +

TRYPTOPHAN + TYROSINE

+ VALINE

Glass bottle x

500ml

FRESENIUS KABI AB -

SUEDI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI;

FRESENIUS KABI AB - SUEDI

RIREGJ

458/19.08.2013 5

Page 61

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62

403

AMINOSTERIL N-

HEPA 8%

Solution for

infusion x (10.4 +

13.09 + 9.71 + 1.1

+ 0.7 + 0.88 + 4.4 +

0.7 + 10.08 + 10.72

+ 2.8 + 5.82 + 4.64

+ 5.73 + 2.24 +

4.42)mg/ml

[L-ISOLEUCINE x 10.4mg +

L-LEUCINE x 13.09mg + L-

LYSINE MONOACETATE x

9.71mg (EQ. TO L-LYSINE x

6.88mg) + L-METHIONINE x

1.1mg + ACETYL CYSTEINE

x 0.7mg (EQ. TO L-

CYSTEINE x 0.52mg) + L-

PHENYLALANINE x 0.88mg

+ L-THREONINE x 4.4mg +

L-TRYPTOPHAN x 0.7mg +

L-VALINE x 10.08mg + L-

ARGININE x 10.72mg + L-

HISTIDINE x 2.8mg +

AMINO-ACETIC ACID x

5.82mg + L-ALANINE x

4.64mg + L-PROLINE x

5.73mg + L-SERINE x

2.24mg + GLACIAL ACETIC

ACID x 4.42mg]/ml

Box x 10 glass

bottles x 500ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI

RIREGJ.

647/10.12.2010

10.86/

pc

Page 62

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63

404 NEPHROTECT

Solution for

infusion x (5.8 +

12.8 + 12 + 2 + 0.4

+ 3.5 + 8.2 + 3 +

8.7 + 8.2 + 9.8 +

6.2 + 5.305 + 3 +

7.6 + 0.6 +

3.155)mg/ml

[L-ISOLEUCINE x 5.8mg + L-

LEUCINE x 12.8mg + L-

LYSINE MONOACETATE x

16.925mg (EQ. TO L-

LYSINE x 12mg) + L-

METHIONINE x 2mg +

ACETYL CYSTEINE x

0.54mg (EQ. TO L-

CYSTEINE x 0.4mg) + L-

PHENYLALANINE x 3.5mg +

L-THREONINE x 8.2mg + L-

TRYPTOPHAN x 3mg + L-

VALINE x 8.7mg + L-

ARGININE x 8.2mg + L-

HISTIDINE x 9.8mg + L-

ALANINE x 6.2mg +

GLYCINE x 5.305mg + L-

PROLINE x 3mg + L-SERINE

x 7.6mg + L-TYROSINE x

0.6mg + N-GLYCYL-L-

TYROSINE x 3.155mg (EQ.

TO GLYCINE x 0.994mg –

TYROSINE x 2.4mg)]/ml

Box x 10 glass

bottles x 500ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI

RIREGJ.

647/10.12.2010

16.57/

pc

405 LAEVOLAC

Concentrate oral

solution x

67g/100ml

LACTULOSE (AS

LACTULOSE LIQUID 50%

m/m = 67% m/v)

Box x 1 plastic

bottle x 100ml

(134g)

FRESENIUS KABI

AUSTRIA GMBH - AUSTRI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI

RIREGJ

433/2/ 28.09.2012 2.49/pc

Page 63

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64

406

FRESUBIN

ORIGINAL

VANILLA

Suspension x

(75mg + 125mg +

85mg + 60mg +

20mg + 47mg +

2mg + 1.5mg +

300mcg + 0.4mg +

30mcg + 0.2mg +

10mcg + 15mcg +

10mcg + 120mcg +

300mcg + 2mcg +

3mg + 16.7mcg +

0.23mg + 0.32mg +

3mg + 0.33mg +

0.6mcg + 1.2mg +

7.5mcg + 50mcg +

15mg +

20mg)/100ml

Na + K + Cl + Ca + Mg + P +

Fe + Zn + Cu + Mn + I + F +

Cr + Mo + Se + Vit. A + β-

carotin + Vit. D3 + Vit. E + Vit.

K1 + Vit. B1 + Vit. B2 +

Niacin + Vit. B6 + Vit. B12 +

Pantothenic acid + Biotin +

Folic acid + Vit. C + Choline Bottle x 500ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

RIREGJ

266/19.04.2013 2.43/pc

407

ZIMACROLFilm-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.1mg)

Box x 3BENEDETTI & CO S.P.A. -

ITALI

SPECIAL PRODUCT'S LINE

S.P.A. - ITALI

REGJ.

604/27.11.20125

408

PIPERACILINA +

TAZOBACTAM

KABI

Powder for solution

for

injection/infusion x

(2000mg + 250mg)

/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM ) +

TAZOBACTAM (as

TAZOBACTAM SODIUM)

Box x 1 glass

vial x 50ml

FRESENIUS KABI

PHARMA PORTUGAL,

LDA. - PORTUGALI

LABORATORIO

FARMACEUTICO C.T., S.R.L. -

ITALI; LABESFAL -

LABORATORIOS ALMIRO,

S.A. - PORTUGALI;

FRESENIUS KABI ANTI -

INFECTIVES S.R.L - ITALI;

LIOSINTEX S.R.L - ITALI

REGJ.

310/17.05.2010 10

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65

409

PIPERACILINA +

TAZOBACTAM

KABI

Powder for solution

for

injection/infusion x

(4g + 500mg) /vial

PIPERACILLIN (as

PIPERACILLIN SODIUM) +

TAZOBACTAM (as

TAZOBACTAM SODIUM)

Box x 10 vials

(for hospital use

only)

FRESENIUS KABI

PHARMA PORTUGAL,

LDA. - PORTUGALI

FRESENIUS KABI/LABESFAL

- PORTUGALI,

LABORATORIO

FARMACEUTICO C.T. -

ITALI;FRESENIUS KABI ANTI -

INFECTIVES S.R.L;

LIOSINTEX S.R.L - ITALI

REGJ.

310/17.05.2010 9.86/pc

410

HAES - STERIL 10

%

Solution for

infusion x

(100g/1000ml +

9g/1000ml)

POLY(0-2-

HYDROXYETHYL)STARCH

(HYDROXYETHYLSTARCH,

HES medium molecular)

Degree of substitution 0.43 -

0.55 Average molecular

weight Mw 200 000 +

SODIUM CHLORIDE

Plastic bag x

500 ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI; FRESENIUS

KABI POLSKA SP. Z.O.O -

POLONI

REGJ.

581/27.10.2008

11.95/

pc

411

HAES - STERIL 10

%

Solution for

infusion x

(100g/1000ml +

9g/1000ml)

POLY(0-2-

HYDROXYETHYL)STARCH

(HYDROXYETHYLSTARCH,

HES medium molecular)

Degree of substitution 0.43 -

0.55 Average molecular

weight Mw 200 000 +

SODIUM CHLORIDE

Glass bottle x

500ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI; FRESENIUS

KABI POLSKA SP. Z.O.O -

POLONI

REGJ.

581/27.10.2008

10.16/

pc

412

HAES - STERIL 10

%

Solution for

infusion x

(100g/1000ml +

9g/1000ml)

POLY(0-2-

HYDROXYETHYL)STARCH

(HYDROXYETHYLSTARCH,

HES medium molecular)

Degree of substitution 0.43 -

0.55 Average molecular

weight Mw 200 000 +

SODIUM CHLORIDE

Plastic bottle x

500ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI; FRESENIUS

KABI POLSKA SP. Z.O.O -

POLONI

REGJ.

581/27.10.2008

10.16

Page 65

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66

413

PROPOFOL 1%

FRESENIUS

Emulsion for

injection or infusion

x 10mg/ml PROPOFOL Flacon x 50ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI

RIREGJ

266/19.04.2013 8.7

414

PROPOFOL 1%

FRESENIUS

Emulsion for

injection or infusion

x 10mg/ml PROPOFOL

Box x 5

ampoules x

20ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI

RIREGJ

266/19.04.2013 10.5

415 INTRALIPID 20%

Emulsion for

infusion x

200mg/ml SOYA-BEAN OIL, REFINED

Glass bottle x

500ml

FRESENIUS KABI AB -

SUEDI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI;

FRESENIUS KABI AB -

SUEDI; SINO-SWED

PHARMACEUTICAL CORP.

LTD - KINE

RIREGJ

458/19.08.2013 9.72

416 INTRALIPID 20%

Emulsion for

infusion x

200mg/ml SOYA-BEAN OIL, REFINED

Plastic bag x

500ml

FRESENIUS KABI AB -

SUEDI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI;

FRESENIUS KABI AB -

SUEDI; SINO-SWED

PHARMACEUTICAL CORP.

LTD - KINE

RIREGJ

458/19.08.2013 11.18

417 INTRALIPID 20%

Emulsion for

infusion x

200mg/ml SOYA-BEAN OIL, REFINED

Glass bottle x

250ml

FRESENIUS KABI AB -

SUEDI

FRESENIUS KABI AUSTRIA

GMBH - AUSTRI;

FRESENIUS KABI AB -

SUEDI; SINO-SWED

PHARMACEUTICAL CORP.

LTD - KINE

RIREGJ

458/19.08.2013 5.32

418 PEDITRACE

Concentrate for

solution for infusion

x (521μg + 53.7μg

+ 3.6μg + 4.38μg +

126μg + 1.31μg)/ml

ZINC CHLORIDE + COPPER

CHLORIDE (2H2O) +

MANGANESE CHLORIDE

(4H2O) + SODIUM

SELENITE ANHYDROUS +

SODIUM FLUORIDE +

POTASSIUM IODIDE

Box x 10 plastic

vials x 10ml

FRESENIUS KABI NORGE

AS - NORVEGJI

FRESENIUS KABI NORGE AS

- NORVEGJI

RIREGJ.

647/10.12.2010 5.71/pc

Page 66

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67

419 VOLULYTE 6%

Solution for

infusion x (60g +

4.63g + 6.02g +

0.30g +

0.30g)/1000ml

POLY(O-2-

HYDROXYETHYL) STARCH

(-MOLAR SUBSTITUTION

0.38-0.45, -MEAN

MOLECULAR WEIGHT =

130.000 Da) + SODIUM

ACETATE TRIHYDRATE +

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

MAGNESIUM CHLORIDE

HEXAHYDRATE

1 Freeflex bag x

500ml

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

FRESENIUS KABI

DEUTSCHLAND GMBH -

GJERMANI

REGJ

307/07.05.2013 11.3

420 ANALGIN Tablets x 500mg METAMIZOLE SODIUM Box x 10

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

190/12.05.2011 0.4

421 BETADINE

Ointment x

100mg/1g

POVIDONE IODINE (eq. to

10mg available IODINE)

Box x tube x

20g

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1.5

422 BETADINE

Cutaneous solution

x 10g/100ml

POVIDONE IODINE (eq. to

1g avaiable IODINE)

Box x 1 plastic

bottle x 100ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1.3

423 BETADINE Pessaries x 200mg

POVIDONE IODINE (eq. to

20mg avaiable IODINE) Box x 14

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1.8

424 BETADINE

Cutaneous solution

x 10g/100ml

POVIDONE IODINE (eq. to

1g avaiable IODINE)

Plastic bottle x

1000ml (for

hospital use)

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 7

425 BRONLES

Hard capsules x

375mg CARBOCISTEINE Box x 30

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

297/18.07.2011 2

Page 67

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68

426 BRONLES

Oral solution, for

children x

125mg/5ml CARBOCISTEINE

Box x 1 glass

bottle x 150ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 2

427 BRONLES

Oral solution x

250mg/5ml CARBOCISTEINE

Box x 1 glass

bottle x 150ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 2.2

428 CAFFETIN

Tablets x (250mg +

210mg + 50mg +

10mg)

PARACETAMOL +

PROPYPHENAZONE +

CAFFEINE + CODEINE

PHOSPHATE

SESQUIHYDRATE Box x 12

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

207/20.05.2011 0.72

429 CAFFETIN COLD

Film - coated

tablets x (500mg +

30mg + 15mg +

60mg)

PARACETAMOL +

PSEUDOEPHEDRINE

HYDROCHLORIDE +

DEXTROMETHORPHAN

HYDROCHLORIDE +

ASCORBIC ACID (as

ASCORBIC ACID DC 95% x

63.16mg) Box x 10

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

450/31.10.2011 1.19

430 CAFFETIN SC

Tablets x (250mg +

210mg + 50mg)

PARACETAMOL +

PROPYPHENAZONE +

CAFFEINE Box x 30

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

446/03.08.2010 0.72

431

CAFFETIN

MENSTRUAL

Film-coated tablets

x 200mg

IBUPROFEN (as

IBUPROFEN LYSINATE x

342mg) Box x 10

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI

RIREGJ

62/06.02.2013 1.47

432

CHLORAMPHENIC

OL ALKALOID

Eye ointment x

10mg/1g CHLORAMPHENICOL

Box x 1 tube x

5g

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

(APL: ALKALOID AD-SKOPJE

- REPUBLIKA E

MAQEDONISE)

RIREGJ.

578/02.11.2009 1.25

433

CHLORAMPHENIC

OL ALKALOID

Ointment x

50mg/1g CHLORAMPHENICOL

Box x 1 tube x

5g

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

(APL: ALKALOID AD-SKOPJE

- REPUBLIKA E

MAQEDONISE)

RIREGJ.

578/02.11.2009 1.25

Page 68

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69

434

DIAZEPAM

ALKALOID

Coated tablets x

2mg DIAZEPAM Box x 30

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

190/12.05.2011 0.45

435 EGLONYL

Hard capsules x

50mg SULPIRIDE Box x 30

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

207/20.05.2011 1.5

436 EGLONYL

Oral solution x

25mg/5ml SULPIRIDE

Box x 1 glass

bottle x 120ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1.2

437 LEGOFER

Oral solution x

40mg/15ml

FE³

(as IRON

PROTEINSUCCINYLATE

800MG/15ML)

Box x 1 bottle x

150ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

385/17.06.2013 3

438 LEXILIUM Tablets x 3mg BROMAZEPAM Box x 30

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1

439

LIDOCAIN

HYDROCHLORID

ALKALOID

Solution for

injection x

40mg/2ml

LIDOCAINE

HYDROCHLORIDE (AS

LIDOCAINE

HYDROCHLORIDE

MONOHYDRATE x

42.64mg/2ml)

Box x 100

ampoules x 2ml

(for hospital use

only)

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

645/10.12.2010 19

440

LIDOCAIN

HYDROCHLORID

ALKALOID

Solution for

injection x

40mg/2ml

LIDOCAINE

HYDROCHLORIDE (AS

LIDOCAINE

HYDROCHLORIDE

MONOHYDRATE x

42.64mg/2ml)

Box x 10

ampoules x 2ml

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

645/10.12.2010 2.21

441

METADON

ALKALOIDDrops x 10mg/ml

METHADONE

HYDROCHLORIDEFlacon x 10ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APLIKANT:

ALKALOID AD-SKOPJE -

MAQEDONI)

REGJ.

551/14.10.2008

2

442

METADON

ALKALOID

Oral solution x

10mg/ml

METHADONE

HYDROCHLORIDE

Box x 1 bottle x

100ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APLIKANT:

ALKALOID AD-SKOPJE -

MAQEDONI)

REGJ.

551/14.10.2008

12

Page 69

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70

443 PANCEF

Film-coated tablets

x 400mg

CEFIXIME (as CEFIXIME

TRIHYDRATE x 447.63mg) Box x 10

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

235/07.06.2011 15

444 PANCEF

Powder for oral

suspension x

100mg/5ml

CEFIXIME (in a form of

CEFIXIME TRIHYDRATE)

Box x 1 glass

bottle x 60ml

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

447/26.08.2009 6.97

445 PANCEF

Film-coated tablets

x 400mg

CEFIXIME (as CEFIXIME

TRIHYDRATE x 447.63mg) Box x 5

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

235/07.06.2011 8.08

446 PARSEDIL

Coated tablets x

75mg DIPYRIDAMOLE Box x 15

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

207/20.05.2011 1.4

447

PHOLCODIN

ALKALOID

Hard capsules x

10mg

PHOLCODINE

MONOHYDRATE Box x 20

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

207/20.05.2011 1.8

448

PHOLCODIN

ALKALOID

Oral solution x

15mg/15ml

PHOLCODINE

MONOHYDRATE

Box x 1 glass

bottle x 150ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1.9

449

PHOLCODIN

ALKALOID

Oral solution, for

children x 4mg/5ml

PHOLCODINE

MONOHYDRATE

Box x 1 glass

bottle x 60ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 1.5

450 PROCULIN

Eye drops, solution

x (3mg +

150mg)/10ml

NAPHAZOLINE

HYDROCHLORIDE + BORIC

ACID

Box x 1 glass

bottle x 10ml +

sterile dropper

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 2

451

PROPAFENON

ALKALOID

Solution for i.v.

injection / infusion x

35mg/10ml

PROPAFENONE

HYDROCHLORIDE

Box x 10

ampoules x

10ml

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

(APLIKANT: ALKALOID AD-

SKOPJE - REPUBLIKA E

MAQEDONISE)

RIREGJ.

446/26.08.2009 5

Page 70

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71

452 REGLAN

Oral solution x

5mg/5ml

METOCLOPRAMIDE

HYDROCHLORIDE (as

METOCLOPRAMIDE

HYDROCHLORIDE

MONOHYDRATE X

5.25mg/5ml)

Box x 1 glass

bottle x 120ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ

282/07.07.2011 2.7

453 RISSAR

Film-coated tablets

x 1mg RISPERIDONE Box x 20

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

447/03.08.2010 1

454 RISSAR

Film-coated tablets

x 3mg RISPERIDONE Box x 20

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

447/03.08.2010 2

455 SKOPRYL PLUS

Tablets x (20mg +

25mg)

LISINOPRIL (as LISINOPRIL

DIHYDRATE x 21.78mg) +

HYDROCHLOROTHIAZIDE Box x 20

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI

RIREGJ

62/06.02.2013 3.5

456 SKOPRYL Tablets x 10mg LISINOPRIL Box x 20

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

(APL: ALKALOID AD-SKOPJE

- REPUBLIKA E

MAQEDONISE)

RIREGJ

46/30.01.2012 2.4

457 SKOPRYL Tablets x 20mg LISINOPRIL Box x 20

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

(APL: ALKALOID AD-SKOPJE

- REPUBLIKA E

MAQEDONISE)

RIREGJ

46/30.01.2012 2.5

458 SOLCOSERYL

Ointment x

2.07mg/g

PROTEIN-FREE

HAEMODIALYSATE OF

BLOOD OF VEAL CALVES,

CHEMICALLY AND

BIOLOGICALLY

STANDARDIZED

(EXPRESSED AS DRY

MATTER)

Box x 1 tube x

20g

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; VALEANT

PHARMACEUTICALS

SWITZERLAND GMBH (APL:

ALKALOID AD-SKOPJE -

MAQEDONI)

RIREGJ

471/11.11.2011 4.5

Page 71

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72

459 SOLCOSERYL Eye gel x 8.30mg/g

PROTEIN-FREE

HAEMODIALYSATE OF

BLOOD OF VEAL CALVES,

CHEMICALLY AND

BIOLOGICALLY

STANDARDIZED

(EXPRESSED AS DRY

MATTER)

Box x 1 tube x

5g

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; VALEANT

PHARMACEUTICALS

SWITZERLAND GMBH (APL:

ALKALOID AD-SKOPJE -

MAQEDONI)

RIREGJ

471/11.11.2011 5

460 SOLCOSERYL Gel x 4.15mg/g

PROTEIN-FREE

HAEMODIALYSATE OF

BLOOD OF VEAL CALVES,

CHEMICALLY AND

BIOLOGICALLY

STANDARDIZED

(EXPRESSED AS DRY

MATTER)

Box x 1 tube x

20g

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; VALEANT

PHARMACEUTICALS

SWITZERLAND GMBH (APL:

ALKALOID AD-SKOPJE -

MAQEDONI)

RIREGJ

471/11.11.2011 4.7

461

TRAMADOL

ALKALOID

Hard capsules x

50mg

TRAMADOL

HYDROCHLORIDE

Box x 20 hard

capsules

(2Blisters x 10)

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

645/10.12.2010 2

462

TRAMADOL

ALKALOID

Solution for

injection x 100

mg/2 ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 2 ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APLIKANT:

ALKALOID AD-SKOPJE -

MAQEDONI)

REGJ.

619/05.11.2008 2.5

463

TRAMADOL

ALKALOID

Solution for

injection x 50

mg/ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 1 ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APLIKANT:

ALKALOID AD-SKOPJE -

MAQEDONI)

REGJ.

619/05.11.2008 1.8

464 ULCODIN

Solution for

injection x

50mg/2ml

RANITIDINE (as

RANITIDINE

HYDROCHLORIDE x

56mg/2ml)

Box x 5

ampoules x 2ml

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI (APL: ALKALOID

AD-SKOPJE - MAQEDONI)

RIREGJ.

207/20.05.2011 1.4

465

VERAPAMIL

ALKALOID

Retard, prolonged-

release film-coated

tablets x 240mg

VERAPAMIL

HYDROCHLORIDE Box x 20

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

269/28.04.2010 2.5

Page 72

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73

466 BISOL

Film-coated tablets

x 2.5mg BISOPROLOL FUMARATE Box x 30

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

577/28.10.2010 1

467 CALIPRA

Film-coated tablets

x 40mg

ATORVASTATIN (as

ATORVASTATIN CALCIUM

x 41.44mg) Box x 30

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

577/28.10.2010 5.8

468 CALIPRA

Film-coated tablets

x 80mg

ATORVASTATIN (as

ATORVASTATIN CALCIUM

x 82.88mg) Box x 30

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

577/28.10.2010 6

469 ZANFEXA XR

Extended-release

capsules x 150mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE x

178.5mg) Box x 30

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE; CIPLA LTD -

INDI

REGJ.

577/28.10.2010 10

470 ZANFEXA XR

Extended-release

capsules x 75mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE x

89.25mg) Box x 30

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID AD-SKOPJE -

REPUBLIKA E

MAQEDONISE; CIPLA LTD -

INDI

REGJ.

577/28.10.2010 7

471

BUPRENORFIN

ALKALOID

Sublingual tablets x

0.4mg

BUPRENORPHINE (as

BUPRENORPHINE

HYDROCHLORIDE x

0.432mg) Box x 28

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE; ETHYPHARM

- FRANCE (APL:ALKALOID

A.D.-SKOPJE - REPUBLIKA E

MAQEDONISE)

REGJ

186/26.04.2012 13.65

472

BUPRENORFIN

ALKALOID

Sublingual tablets x

2mg

BUPRENORPHINE (as

BUPRENORPHINE

HYDROCHLORIDE x

2.16mg) Box x 28

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE; ETHYPHARM

- FRANCE (APL:ALKALOID

A.D.-SKOPJE - REPUBLIKA E

MAQEDONISE)

REGJ

186/26.04.2012 20

Page 73

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74

473

BUPRENORFIN

ALKALOID

Sublingual tablets x

8mg

BUPRENORPHINE (as

BUPRENORPHINE

HYDROCHLORIDE x

8.64mg) Box x 28

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE; ETHYPHARM

- FRANCE (APL:ALKALOID

A.D.-SKOPJE - REPUBLIKA E

MAQEDONISE)

REGJ

186/26.04.2012 78

474

AMINOFILIN

ALKALOID

Prolonged-release

tablets x 350mg

THEOPHYLLINE

ETHYLENEDIAMINE

ANHYDROUS (eq. to

THEOPHYLLINE

ANHYDROUS x 299.95mg)

Box x 20 (2

blisters x 10

tablets)

ALKALOID A.D.-SKOPJE -

REPUBLIKA E

MAQEDONISE

ALKALOID A.D.-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ

433/17.09.2012 1.8

475 PODAL

Film - coated

tablets x 200mg

CEFPODOXIME (as

CEFPODOXIME PROXETIL

x 260.90mg) Box x 10

ALKALOID AD - SKOPJE -

MAQEDONI

ALKALOID AD - SKOPJE -

MAQEDONI; LUPIN LIMITED -

INDI; (APL: ALKALOID AD -

SKOPJE - MAQEDONI)

REGJ

140/19.03.2013 15

476 PODAL

Powder for oral

suspension x

40mg/5ml

CEFPODOXIME (as

CEFPODOXIME PROXETIL

x 52.18mg/5ml)

Box x 1 bottle x

100ml

ALKALOID AD - SKOPJE -

MAQEDONI

ALKALOID AD - SKOPJE -

MAQEDONI; LUPIN LIMITED -

INDI; (APL: ALKALOID AD -

SKOPJE - MAQEDONI)

REGJ

140/19.03.2013 11

477 RONAL

Film-coated tablets

x 0.25mg

ROPINIROLE (as

HYDROCHLORIDE) Box x 21

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; INDOCO

REMEDIES LIMITED-GOA -

INDI

REGJ

422/11.07.2013 3.6

478 RONAL

Film-coated tablets

x 1mg

ROPINIROLE (as

HYDROCHLORIDE) Box x 21

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; INDOCO

REMEDIES LIMITED-GOA -

INDI REGJ 3/07.01.2013 7.47

479 RONAL

Film-coated tablets

x 2mg

ROPINIROLE (as

HYDROCHLORIDE) Box x 21

ALKALOID AD-SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; INDOCO

REMEDIES LIMITED-GOA -

INDI

REGJ

422/11.07.2013 10.12

480 ACLOCEN

Film-coated tablets

x 100mg ACECLOFENAC Box x 40

ESPECIALIDADES

FARMACEUTICAS

CENTRUM SA - SPANJE

RIVOPHARM

PHARMACEUTICALS

LABORATORIES - ZVICER

REGJ

359/28.05.2013 4.76

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75

481 DIMEGAN Capsules x 12mg

BROMPHENIRAMINE

MALEATE Box x 10

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE

LAPHAL INDUSTRIE -

FRANCE

REGJ

451/13.08.2013 3.4

482 MAGNESPASMYL

Coated tablets x

47.4mg

MAGNESIUM (as

MAGNESIUM LACTATE

DIHYDRATE x 465.4mg) Box x 50

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE

LAPHAL INDUSTRIE -

FRANCE

REGJ

451/13.08.2013 8.5

483 PHYSIOMYCINE Capsules x 300mg

METHYLENECYCLINE

CHLORHYDRATE Box x 16

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE

LAPHAL INDUSTRIE -

FRANCE

REGJ

451/13.08.2013 7.5

484 CORTISAL

Cream x (10g +

0.5g)/100g

DIPROPYLENE GLYCOL

SALICYLATE +

PREDNISOLONE

Box x 1 tube x

30g

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE

THEPENIER PHARMA

INDUSTRIE - FRANCE

REGJ

451/13.08.2013 3.7

485

COLLUNOVAR

0.11%

Solution for oral

spray pulverization

x 0.11%

CHLORHEXIDIN

GLUCONATE

Box x 1 flacon x

40ml

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE

THEPENIER PHARMA

INDUSTRIE - FRANCE

REGJ

451/13.08.2013 6.8

486 LODINE

Coated tablets x

200mg ETODOLAC (MICRONISED) Box x 30

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE DELPHARM - FRANCE

REGJ

451/13.08.2013 6.4

487

LODINECoated tablets x

300mgETODOLAC (micronised) Box x 20

"LABORATOIRES

PHARMACEUTIQUES

DEXO" FRANCE

"THEPENIER PHARMA

INDUSTRIE" FRANCE

Regj.451/13.08.2013;

Nd.U.477/09.09.2013

6.9

488 HEXATRIONE 2%

Suspension for

injection (intra-

articular) x

20mg/ml

TRIAMCINOLONE

HEXACETONIDE

Box x 1vial x

2ml

LABORATOIRES

PHARMACEUTIQUES

DEXO - FRANCE VALDEPHARM - FRANCE

REGJ

451/13.08.2013 12

489

RHINAMIDE

Solution for nasal

spray x 91G +

0.2G)/100ml

EPHEDRINE

HYDROCHLORIDE +

BENZOIC ACID

Box x 1

nebulizer flacon

x 20ml

"LABORATOIRE BAILLY

CREAT" FRANCE

"LABORATOIRE

SOPHARTEX" FRANCERegj.475/09.09.2013

2.3

490

PULMOSERUMOral solution x

(0.8g + 0.5g)/100mlCODEINE + GUAIACOL

Box x 1 bottle x

200ml

"LABORATOIRE BAILLY

CREAT" FRANCE"H2 PHARMA" FRANCE Regj.475/09.09.2013

2.6

491

PULMODEXANE

300MG/100ML

SANS SUCRE

Sugar free,

sweetened oral

solution x

300mg/100ml

DEXTROMETHORPHAN

HYDROBROMIDE

Box x 1 bottle x

150ml

"LABORATOIRE BAILLY

CREAT" FRANCE"H2 PHARMA" FRANCE Regj.475/09.09.2013

3.7

Page 75

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76

492

COVATINE 50 MGCoated tablets x

50mg

CAPTODIAMINE

HYDROCHLORIDEBox x 45

"LABORATOIRE BAILLY

CREAT" FRANCE

"LABORATOIRE BAILLY

CREAT" FRANCERegj.475/09.09.2013

5.8

493

PULMODEXANE

30 MG

Film coated tablets

s 30mg

DEXTROMETHORPHAN

HYDROBROMIDEBox x 12

"LABORATOIRE BAILLY

CREAT" FRANCE

"LABORATOIRE BAILLY

CREAT" FRANCERegj.475/09.09.2013

3

494

PYOREX

Toothpaste x

(0.0067g +

0.76g)/100g

ETHACIDRINE LACTATE +

RICINOLEATE SODIUM

Box x 1

aluminium tube

x 90g

"LABORATOIRE BAILLY

CREAT" FRANCE

"THEPENIER PHARMA

INDUSTRIE" FRANCERegj.475/09.09.2013

3.5

495

BRULEX

Ointment x (5g +

0.5g + 0.03g +

0.0036g +

1g)/100g

ZINC OXIDE + PHENAZONE

+ PHENOL + SODIUM

SALYCILATE + BALSAM OF

PERU

Box x 1

aluminium tube

x 30g

"LABORATOIRE BAILLY

CREAT" FRANCE

"THEPENIER PHARMA

INDUSTRIE" FRANCERegj.475/09.09.2013

3.8

496

ACIDE FOLIQUE

CCD 0.4 MGTablets x 0.4mg FOLIC ACID Box x 30

"LABORATOIRE CCD"

FRANCE

"LABORATOIRE BAILLY

CREAT" FRANCERegj.475/09.09.2013

3.86

497

QUININE

VITAMINE C

GRAND

Coated tablets x

(50mg + 50mg)

QUININE BISULPHATE (eq.

to. ANHYDROUS QUININE

SULPHATE X 40MG) +

ASCORBIC ACID

Box x 24"LABORATOIRES DU

GOMENOL" FRANCE

"LABORATOIRE BAILLY

CREAT" FRANCERegj.475/09.09.2013

2.8

498

HEXAQUINECoated tablets x

120mg

QUININE BENZOATE (eq. to

QUININE BASE X 87.2mg) Box x 18

"LABORATOIRES DU

GOMENOL" FRANCE

"LABORATOIRE BAILLY

CREAT" FRANCERegj.475/09.09.2013

4

499 INOFER

Coated tablets x

(100mg + 100mg)

FERROUS SUCCINATE

(corresp. to 32.5mg IRON) +

SUCCINIC ACID Box x 100

LISAPHARM

LABORATOIRES -

FRANCE AJC PHARMA - FRANCE

REGJ

604/27.11.2012 8

500 AROLAC

Divisible tablets x

0.2mg

LISURIDE HYDROGEN

MALEATE Box x 20

LISAPHARM

LABORATOIRES -

FRANCE

DELPHARM-LILLE SAS -

FRANCE

REGJ

604/27.11.2012 7

501 TRONOTHANE

Gel for topical

application x 1

g/100 g

PROMOCAINE

HYDROCHLORIDE

Box x 1 tube x

30g

LISAPHARM

LABORATOIRES -

FRANCE FAMAR L'AIGLE - FRANCE

REGJ

604/27.11.2012 4.6

502 SOLUBACTER

Soap solution for

topical application

x 1g/100ml TRICLOCARBAN

Box x 1 flacon x

150ml

LISAPHARM

LABORATOIRES -

FRANCE

LABORATOIRE CHEMINEAU -

FRANCE; FARMACLAIR -

FRANCE

REGJ

604/27.11.2012 4.7

Page 76

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77

503 SOLUBACTER

Soap solution for

topical application

x 1g/100ml TRICLOCARBAN

Box x 1 flacon x

400ml

LISAPHARM

LABORATOIRES -

FRANCE

LABORATOIRE CHEMINEAU -

FRANCE; FARMACLAIR -

FRANCE

REGJ

604/27.11.2012 8.5

504

CUTISAN

Powder for topical

application x

1g/100 g

TRICLOCARBAN Flacon x 80g

LISAPHARM

LABORATOIRES -

FRANCE

THEPENIER PHARMA

INDUSTRIE - FRANCE

REGJ.

604/27.11.2012

5

505 TENSIONORME

Divisible tablets x

(2.50mg + 0.10mg)

BENDROFLUMETHIAZIDE +

RESERPINE Box x 24

LISAPHARM

LABORATOIRES -

FRANCE

DELPHARM BRETIGNY -

FRANCE

REGJ

604/27.11.2012 6

506 ACERBINE

Solution x (1.3779g

+0.041g +

0.154g)/100g

MALIC ACID + SALICYLIC

ACID + BENZOIC ACID

Box x 1 plastic

bottle x 80ml

PHARMAZEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

266/12.06.2012 3.3

507 ACERBINE

Ointment x

(0.0133g + 0.05g +

0.45g)/100g

SALICYLIC ACID +

BENZOIC ACID + MALIC

ACID

Box x 1 tube x

30g

PHARMACEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMACEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

409/07.10.2011 2.4

508 CYNARIX

Sugar-coated

tablets x 55mg

CYNARAE FOLIUM

(EXTRACT) Box x 24

PHARMAZEUTISCHE

FABRIK MONTAVIT

GMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GMBH -

AUSTRI

RIREGJ.

435/29.07.2010 2

509 CYNARIX

Oral solution x

4g/100ml

CYNARAE FOLIUM

(EXTRACT)

Box x 1 glass

bottle x 100ml

PHARMAZEUTISCHE

FABRIK MONTAVIT

GMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GMBH -

AUSTRI

RIREGJ.

446/03.08.2010 2.75

510 DERMODRIN

Ointment x

2g/100g

DIPHENHYDRAMINE

HYDROCHLORIDE

Box x 1 tube x

20g

PHARMAZEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

167/19.04.2012 1.8

511 CALMABEN

Sugar coated

tablets x 50mg

DIPHENHYDRAMINE

HYDROCHLORIDE Box x 30

PHARMAZEUTISCHE

FABRIK MONTAVIT

GmbH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GmbH -

AUSTRI

RIREGJ.

251/23.04.2009 2.4

512 TAVIPEC Capsules x 150mg

LAVANDULAE LATIFOLIAE

AETHEROLEUM Box x 30

PHARMAZEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

266/12.06.2012 2.25

513

CATHEJELL MIT

LIDOCAIN

Anaesthetic gel x

(2g + 0.05g)/100g

LIDOCAINE

HYDROCHLORIDE (H2O) +

CHLORHEXIDINE

DIHYDROCHLORIDE

Box x 1

accordion

syringes x 12.5g

gel

PHARMAZEUTISCHE

FABRIK MONTAVIT

GmbH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GmbH -

AUSTRI

REGJ.

286/11.05.2009 1.2

Page 77

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78

514

CATHEJELL MIT

LIDOCAIN

Anaesthetic gel x

(2g + 0.05g)/100g

LIDOCAINE

HYDROCHLORIDE (H2O) +

CHLORHEXIDINE

DIHYDROCHLORIDE

Box x 5

accordion

syringes x 12.5g

gel

PHARMAZEUTISCHE

FABRIK MONTAVIT

GmbH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GmbH -

AUSTRI

REGJ.

286/11.05.2009 5.5

515

CATHEJELL MIT

LIDOCAIN

Anaesthetic gel x

(2g + 0.05g)/100g

LIDOCAINE

HYDROCHLORIDE (H2O) +

CHLORHEXIDINE

DIHYDROCHLORIDE

Box x 25

accordion

syringes x 12.5g

gel

PHARMAZEUTISCHE

FABRIK MONTAVIT

GmbH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GmbH -

AUSTRI

REGJ.

286/11.05.2009 25

516

CATHEJELL MIT

LIDOCAIN

Anaesthetic gel x

(2g + 0.05g)/100g

LIDOCAINE

HYDROCHLORIDE (H2O) +

CHLORHEXIDINE

DIHYDROCHLORIDE

Box x 5

accordion

syringes x 8.5g

gel

PHARMAZEUTISCHE

FABRIK MONTAVIT

GmbH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GmbH -

AUSTRI

REGJ.

286/11.05.2009 5

517

CATHEJELL MIT

LIDOCAIN

Anaesthetic gel x

(2g + 0.05g)/100g

LIDOCAINE

HYDROCHLORIDE (H2O) +

CHLORHEXIDINE

DIHYDROCHLORIDE

Box x 25

accordion

syringes x 8.5g

gel

PHARMAZEUTISCHE

FABRIK MONTAVIT

GmbH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GmbH -

AUSTRI

REGJ.

286/11.05.2009 22.5

518 TUSSAVIT

Cough syrup x

(7.53g +

7.53g)/100g

LIQUID EXTRACT OF

THYME HERB + LIQUID

EXTRACT OF RIBWORT

PLANTAIN LEAVES

Box x 1 glass

bottle x 125g

PHARMAZEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

380/13.08.2012 1.76

519 TUSSAVIT

Cough syrup x

(7.53g +

7.53g)/100g

LIQUID EXTRACT OF

THYME HERB + LIQUID

EXTRACT OF RIBWORT

PLANTAIN LEAVES

Box x 1 glass

bottle x 250g

PHARMAZEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

380/13.08.2012 2.5

520 INKONTAN

Film - coated

tablets x 15mg TROSPIUM CHLORIDE Box x 20

PHARMACEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMACEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI; DR. R. PFLEGER,

CHEMISCHE FABRIK GMBH -

GJERMANI

RIREGJ

409/07.10.2011 4.5

521 INKONTAN

Film - coated

tablets x 30mg TROSPIUM CHLORIDE Box x 20

PHARMACEUTISCHE

FABRIK MONTAVIT

GESMBH - AUSTRI

PHARMACEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI; DR. R. PFLEGER,

CHEMISCHE FABRIK GMBH -

GJERMANI

RIREGJ

409/07.10.2011 6.4

Page 78

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79

522 BENKETOL

Oral drops, solution

x 20mg/ml

KETOROLAC

TROMETHAMINE

Box x 1 glass

bottle x 10ml

PHARMABER S.R.L. -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

188/12.05.2011 5.8

523 BENKETOL

Solution for

injection x 30mg/ml

KETOROLAC

TROMETHAMINE

Box x 3

ampoules x 1ml

PHARMABER S.R.L. -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

188/12.05.2011 3.8

524 SILMAR

Hard capsules x

200 mg

EXTRACT OF SILYBUM

MARIANUM CONTAINING

FLAVONOIDS EXPRESSED

AS SILYMARIN Box x 30

PHARMABER S.R.L. -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

181/18.03.2009 9

525 TURM

Nebulising Solution

x 0.1% FLUNISOLIDE

Box x flacon x

30ml

BIORES ITALIA SRL -

ITALI

CONSORZIO

FARMACEUTICO E

BIOTECNOLOGICO

BIOPROGRESS

SOC,CONSOR. ARL - ITALI;

FARMILA THEA

FARMACEUTICI SPA - ITALI

REGJ.

448/26.08.2009 10

526 TANTUM VERDE

Oromucosal

solution, spray x

0.15% (w/v)

BENZYDAMINE

HYDROCHLORIDE

Box x 1

nebulising

flacon x 30ml

AZ.CHIM.RIUN. ANGELINI

FRANCESCO ACRAF

SPA - ITALI

AZ.CHIM.RIUN. ANGELINI

FRANCESCO ACRAF SPA -

ITALI

REGJ

61/06.02.2013 4.5

527 TANTUM VERDE

Oromucosal

solution, spray x

0.30% (w/v)

BENZYDAMINE

HYDROCHLORIDE

Box x 1

nebulising

flacon x 15ml

AZ.CHIM.RIUN. ANGELINI

FRANCESCO ACRAF

SPA - ITALI

AZ.CHIM.RIUN. ANGELINI

FRANCESCO ACRAF SPA -

ITALI

REGJ

61/06.02.2013 4.5

528 TANTUM VERDE

Mouthwash

solution x 0.15%

(w/v)

BENZYDAMINE

HYDROCHLORIDE

Box x 1 flacon x

120ml

AZ.CHIM.RIUN. ANGELINI

FRANCESCO ACRAF

SPA - ITALI

AZ.CHIM.RIUN. ANGELINI

FRANCESCO ACRAF SPA -

ITALI

REGJ

140/19.03.2013 4

529

CONNETTIVINA

PLUS

Cream x (0.2% +

1%) w/w

HYALURONIC ACID

SODIUM SALT + SILVER

SULPHADIAZINE

Box x 1 tube x

25g

FIDIA FARMACEUTICI

SPA - ITALI

FIDIA FARMACEUTICI SPA -

ITALI; ZETA FARMACEUTICI

SPA - ITALI

RIREGJ.

450/31.10.2011

5.4

530

CONNETTIVINA

PLUS

Impregnated gauze

pads x (2mg +

40mg)/ 10cm x

10cm

HYALURONIC ACID

SODIUM SALT + SILVER

SULPHADIAZINE

Box x 10 gauze

pad - 10 x 10cm

FIDIA FARMACEUTICI

SPA - ITALI

FIDIA FARMACEUTICI SPA -

ITALI

RIREGJ

450/31.10.2011 5.8

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80

531

CONNETTIVINA

PLUS

Impregnated gauze

pads x (4mg +

80mg)/ 10cm x

20cm

HYALURONIC ACID

SODIUM SALT + SILVER

SULPHADIAZINE

Box x 10 gauze

pad - 10 x 20cm

FIDIA FARMACEUTICI

SPA - ITALI

FIDIA FARMACEUTICI SPA -

ITALI

RIREGJ

450/31.10.2011 8

532

CONNETTIVINA

PLUS

Impregnated gauze

pads x (12mg +

240mg)/ 20cm x

30cm

HYALURONIC ACID

SODIUM SALT + SILVER

SULPHADIAZINE

Box x 5 gauze

pad - 20 x 30cm

FIDIA FARMACEUTICI

SPA - ITALI

FIDIA FARMACEUTICI SPA -

ITALI

RIREGJ

450/31.10.2011 11

533 HYALGAN

Solution for

injection for

intraarticular use x

20mg/2ml

HYALURONIC ACID

SODIUM SALT

Box x 1 pre-

filled syringe x

2ml

FIDIA FARMACEUTICI

SPA - ITALI

FIDIA FARMACEUTICI SPA -

ITALI

RIREGJ

450/31.10.2011 16.3

534 CALCIFOLIN

Hard capsules x

15mg

FOLICIN ACID (AS

CALCIUM FOLINATE X

19.1MG) Box x 10

IBIRN-ISTITUTO

BIOTERAPICO

NAZIONALE SRL - ITALI

IBIRN-ISTITUTO

BIOTERAPICO NAZIONALE

SRL - ITALI

RIREGJ

423/11.07.2013 9

535 ARTROSILENE

Cutaneous foam x

15%

KETOPROFEN LYSINE

SALT

Box x 1

Container under

pressure x 50ml

DOMPE FARMACEUTICI

SPA - ITALI

DOMPE PHA.R.MA. SPA -

ITALI, AEROSOL SERVICE

ITALIANA SRL - ITALI,

BIOLAB SPA - ITALI,

ZELLAEROSOL GMBH -

GJERMANI,

UNTERSUCHUNGSINSTITUT

HEPPELER GMBH -

GJERMANI

RIREGJ.

392/01.07.2009 6.6

536 ARTROSILENE

Prolonged release

hard capsules x

320 mg

KETOPROFEN LYSINE

SALT

Box x 20

capsules

DOMPE FARMACEUTICI

SPA - ITALI

ISTITUTO DE ANGELI S.R.L -

ITALI, VALPHARMA S.P.A. -

ITALI

RIREGJ.

392/01.07.2009 7.21

537 ARTROSILENE Gel x 5%

KETOPROFEN LYSINE

SALT

Box x tube x

50g

DOMPE FARMACEUTICI

SPA - ITALI

DOMPE PHA.R.MA S.P.A. -

ITALI

RIREGJ.

392/01.07.2009 5.1

538 ARTROSILENE

Solution for

injection x

160mg/2ml KETOPROFENE LYSINE

Box x 6

ampoules x 2ml

DOMPE FARMACEUTICI

SPA - ITALI

ALFA WASSERMAN SPA -

ITALI; ABIOGEN PHARMA

SPA - ITALI; EUROFINS

BIOLAB SRL - ITALI

RIREGJ.

168/04.05.2011 3.78

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81

539 ARTROSILENE

Suppositories x

160mg

KETOPROFEN LYSINE

SALT Box x 10

DOMPE FARMACEUTICI

SPA - ITALI

ISTITUTO DE ANGELI SRL -

ITALI; MONTEFARMACO

SPA - ITALI

RIREGJ

598/26.11.2012 4.47

540 OKI

Suppositories x

160mg KETOPROFEN LYSINE Box x 10 DOMPE SPA - ITALI

ISTITUTO DE ANGELI SRL -

ITALI, MONTEFARMACO

SPA - ITALI

RIREGJ.

392/01.07.2009 4.47

541 LEVOTUSS Syrup x 30mg/5ml LEVODROPROPIZINE

Box x flacon x

200ml

DOMPE FARMACEUTICI

SPA - ITALI

DOMPE SPA - ITALI; ALFA

WASSERMANN SPA - ITALI

RIREGJ

166/19.04.2012 4.8

542 LEVOTUSS

Oral drops, solution

x 60mg/ml LEVODROPROPIZINE

Box x flacon x

30ml

DOMPE FARMACEUTICI

SPA - ITALI DOMPE SPA - ITALI

RIREGJ

166/19.04.2012 5.22

543 MIOTENS

Solution for I.M

injection x 4mg/2ml THIOCOLCHICOSIDE

Box x 6 vials x

2ml DOMPE SPA - ITALI

ABIOGEN PHARMA S.P.A. -

ITALI; EUROFINS BIOLAB -

ITALI

RIREGJ.

581/29.10.2010 5.9

544

MIOTENS

CONTRATTURE E

DOLORE

Cutaneous foam x

0.25g/100ml THIOCOLCHICOSIDE

Box x 1

container under

pressure x 30ml DOMPE SPA - ITALI

DOMPE SPA - ITALI;

ZELLAEROSOL GMBH -

GJERMANI; AEROSOL

SERVICE ITALIANA - ITALI;

EUROFINS BIOLAB S.R.L -

ITALI

RIREGJ.

581/29.10.2010 5.8

545 OKI

Suppositories x

30mg KETOPROFEN LYSINE Box x 10 DOMPE SPA - ITALI

ISTITUTO DE ANGELI SRL -

ITALI, MONTEFARMACO

SPA - ITALI

RIREGJ.

392/01.07.2009 4.4

546 OKI

Suppositories x

60mg

KETOPROFEN LYSINE

SALT Box x 10 DOMPE SPA - ITALI

ISTITUTO DE ANGELI SRL -

ITALI; MONTEFARMACO

SPA - ITALI

RIREGJ

598/26.11.2012 4.4

547

OKI

INFIAMMAZIONE

E DOLORE

Mouthwash

solution x 1.6% KETOPROFEN LYSINE

Box x 1 flacon x

150ml DOMPE SPA - ITALI

DOMPE PHA.R.MA S.P.A. -

ITALI, ALFA WASSERMAN

S.P.A. - ITALI,

MONTEFARMACO S.P.A. -

ITALI

RIREGJ.

392/01.07.2009 5.6

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82

548 OKI

Granules for oral

solution x 80mg

KETOPROFEN LYSINE

(CORRESPONDING TO

KETOPROFEN x 50MG) Box x 30 bags DOMPE SPA - ITALI

LAMP SAN PROSPERO

S.P.A. - ITALI, DOMPE

PHA.R.MA S.P.A. - ITALI

RIREGJ.

392/01.07.2009 4

549 OKI

Oral drops solution

x 80mg/ml

KETOPROFENE LYSINE

SALT x 8mg/100ml

Box x 1 flacon x

30ml DOMPE SPA - ITALI

DOMPE PHA.R.MA SPA -

ITALI; MONTEFARMACO

SPA - ITALI

RIREGJ.

268/28.04.2010 5.8

550 FLUIFORT

Granules for oral

solution x 2.7g

CARBOCYSTEINE LYSINE

(as CARBOCYSTEINE

LYSINE MONOHYDRATE) Box x 30 bags

DOMPE FARMACEUTICI

SPA - ITALI

DOMPE PHA.R.MA S.P.A. -

ITALI, FINE FOODS N.T.M.

SPA - ITALI

RIREGJ.

392/01.07.2009 13

551 FLUIFORT Syrup x 9g/100ml

CARBOCYSTEINE LYSINE

(as CARBOCYSTEINE

LYSINE MONOHYDRATE)

Box x flacon x

200ml

DOMPE FARMACEUTICI

SPA - ITALI

DOMPE PHA.R.MA. SPA -

ITALI, ALFA WASSERMANN

S.P.A - ITALI

RIREGJ.

392/01.07.2009 5

552 NEKACIN

Solution for

injection x

500mg/2ml

AMIKACIN (as AMIKACIN

SULPHATE x 667.5mg/2ml)

Box x 5

ampoules x 2ml

NEW RESEARCH SRL -

ITALI FISIOPHARMA SRL - ITALI

REGJ

186/26.04.2012 7

553 NEKACIN

Solution for

injection x

1000mg/4ml

AMIKACIN (as AMIKACIN

SULPHATE x 1335mg/4ml)

Box x 1

ampoules x 4ml

NEW RESEARCH SRL -

ITALI FISIOPHARMA SRL - ITALI

REGJ

186/26.04.2012 2.5

554 DAVIXON

Powder and

solvent for solution

for injection x

1g/vial

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM

3.5 H2O x 1.193g/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent

NEW RESEARCH SRL -

ITALI

LA.FA.RE SRL - ITALI;

SPECIAL PRODUCTS LINE

SRL - ITALI; LABORATORIO

ITALIANO BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

RIREGJ

450/31.10.2011 3.6

555 CADTRE

Effervescent

granules x

(1000mg + 880 IU)

/ sachet

CALCIUM (AS CALCIUM

CARBONATE x 2500mg) +

CHOLECALCIFEROL (Vit.

D3)

Box x 30

sachets

NEW RESEARCH SRL -

ITALI LA.FA.RE. SRL - ITALI

RIREGJ

333/29.08.2011 4.2

556 NERELID

Granules for oral

solution x

100mg/sachet NIMESULIDE

Box x 30

sachets

NEW RESEARCH SRL -

ITALI LA.FA.RE. SRL - ITALI

RIREGJ

409/07.10.2011 2.5

Page 82

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83

557 SALOCEF

Powder and

solvent for solution

for I.M injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM

x1.048g/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent

(Lidocaine

hydrochloride) x

4ml

NEW RESEARCH SRL -

ITALI

LA.FA.RE. SRL - ITALI;

SPECIAL PRODUCTS LINE

S.R.L. - ITALI

RIREGJ

409/07.10.2011 3.05

558 NEFAZOL

Powder and

solvent for solution

for I.M injection x

1g/vial

CEFAZOLINE (as

CEFAZOLINE SODIUM x

1.048/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent

(Lidocaine

hydrochloride) x

4ml

NEW RESEARCH SRL -

ITALI

LA.FA.RE. SRL - ITALI;

SPECIAL PRODUCTS LINE

S.R.L. - ITALI

RIREGJ

409/07.10.2011 1.2

559 NECID

Powder and

solvent for solution

for IM injection x

1g/2.5ml

CEFONICID DISODIUM X

1.081G (EQUIVALENT TO

1G CEFONICID)

Box x 1 flacon

powder + 1

flacon solvent

NEW RESEARCH SRL -

ITALI

LA.FA.RE. SRL - ITALI;

SPECIAL PRODUCTS LINE

S.R.L. - ITALI

RIREGJ

409/07.10.2011 3.6

560 LAUROMICINA Tablets x 500mg

ERYTHROMYCIN (as

ERYTHROMYCIN

STEARATE x 833mg) Box x 12

NEW RESEARCH S.R.L.

ITALY LA.FA.RE. SRL - ITALI

REGJ.

188/12.05.2011 5

561 NAFORDYL Tablets x 20mg

LISINOPRIL (as LISINOPRIL

DIHYDRATE x 21.78mg) Box x 28 KLEVA SA - GREQI KLEVA SA - GREQI

RIREGJ

380/13.08.2012 7

562 TYPOFEN

Film-coated tablets

x (100mg + 25mg)

ATENOLOL +

CHLORTALIDONE Box x 28

CLD PHARMACEUTICAL

PRODUCTS LTD - QIPRO

KLEVA SA - GREQI (APL:

KLEVA SA - GREQI)

RIREGJ

380/13.08.2012 6

563 VILONIT

Gel for external

use x 10mg/g

DICLOFENAC SODIUM ( as

DICLOFENAC

DIETHYLAMMONIUM x

11.60mg/g)

Box x 1 tube x

100g KLEVA SA - GREQI KLEVA SA - GREQI

RIREGJ

380/13.08.2012 2.7

564 ALCITON

Nasal spray

solution x 100 IU /

dose

CALCITONIN (as

CALCITONIN SALMON x

1111.11 IU/ml

Box x 1 glass

vial with

metered pump

and sprayer x

5ml x 28 doses KLEVA SA - GREQI KLEVA SA - GREQI

REGJ

297/25.06.2012 15

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84

565 ODNATRON

Film-coated tablets

x 8mg

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE x 10mg) Box x 15 KLEVA SA - GREQI KLEVA SA - GREQI

REGJ

297/25.06.2012 60

566 ODNATRON

Solution for

injection x 8mg/4ml

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE x 2.5mg/ml)

Box x 5

ampoules x 4ml KLEVA SA - GREQI KLEVA SA - GREQI

REGJ

297/25.06.2012 15

567 SOLUDAMIN

Oral solution x

100mg/ml LEVOCARNITINE

Box x 10 flacons

x 10ml KLEVA S.A. - GREQI KLEVA S.A. - GREQI

REGJ.

192/19.03.2009 7

568

THIOPENTAL

VUAB

Powder for solution

for injection x

1g/vial

THIOPENTAL SODIUM AND

SODIUM CARBONATE Box x 1 vial

VUAB PHARMA AS -

REPUBLIKA CEKE

VUAB PHARMA AS -

REPUBLIKA CEKE

REGJ

527/23.12.2011 1.2

569

SUXAMETHONIU

M CHLORID VUAB

Powder for solution

for injection x 100

mg/vial

SUXAMETHONIUM

CHLORIDE (as

SUXAMETHONIUM

CHLORIDE DIHYDRATE x

110mg) Box x 1 vial

VUAB PHARMA AS -

REPUBLIKA CEKE

VUAB PHARMA AS -

REPUBLIKA CEKE

REGJ

307/07.05.2013 1.4

570

RISPERIDON-1A

PHARMA

Film-coated tablets

x 3mgRISPERIDONE Box x 20

1A PHARMA GMBH -

GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI

REGJ.

418/12.10.2011 4

571

COTRIM 960-1A

PHARMA

Tablets x (800mg +

160mg)

SULFAMETHOXAZOLE +

TRIMETHOPRIMBox x 20

1A PHARMA GMBH -

GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI

REGJ.

418/12.10.20112.2

572

DORZOSTILLEye drops, solution

x 2%

DORZOLAMIDE (as

DORZOLAMIDE

HYDROCHLORIDE x

22.3mg/ml)

Box x 1 bottle x

5ml

BRUSCHETTINI SRL -

ITALIBRUSCHETTINI SRL - ITALI

REGJ.

208/07.05.2012

3.97

573 LACTEOL

Hard capsules x 5

000 000 000

LACTOBACILLUS LB (L.

FERMENTUM + L.

DELBRUECKII) Box x 20

BRUSCHETTINI SRL -

ITALI

BRUSCHETTINI SRL - ITALI,

AXCAN PHARMA SA -

FRANCE

REGJ.

656/20.11.2008 6.41

574 LACTEOL

Oral powder x 10

000 000

000/sachet

LACTOBACILLUS LB (L.

FERMENTUM + L.

DELBRUECKII)

Box x 10

sachets

BRUSCHETTINI SRL -

ITALI

BRUSCHETTINI SRL - ITALI,

AXCAN PHARMA SA -

FRANCE

REGJ.

656/20.11.2008 6.98

Page 84

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85

575 LANTIGEN B

Oral drops

suspension x (63.2

+ 126.2 + 39.9 +

79.6 + 50.2 + 39.8)

UA/ml

STREPTOCOCCUS

PNEUMONIAE TYPE 3 +

STREPTOCOCCUS

PYOGENES GROUP A +

BRANHAMELLA

CATARRHALIS +

STAPHYLOCOCCUS

AUREUS + HAEMOPHYLUS

INFLUENZAE TYPE B +

KLEBSIELLA PNEUMONIAE

Box x 1 flacon x

18ml

BRUSCHETTINI SRL -

ITALI BRUSCHETTINI SRL - ITALI

RIREGJ.

632/19.11.2009 5.91

576 OTOPROFEN

Ear drops solution

x (1% + 5%)

PROCAINE

HYDROCHLORIDE +

PHENAZONE

Box x 1 glass

bottle with a

dropper x 10ml

BRUSCHETTINI SRL -

ITALI

LABORATORIO CHIMICO

FARMACEUTICO A, SELLA

SRL - ITALI

REGJ.

647/25.11.2009 3.46

577 BIOARGININA

Oral solution x

1.66g/20ml L-ARGININE

Box x 20 vials x

20ml

FARMACEUTICI DAMOR

SPA - ITALI

FARMACEUTICI DAMOR SPA

- ITALI; MIPHARM SPA -

ITALI

RIREGJ.

291/06.05.2010 13.7

578 FITOSTIMOLINE Cream x 15%

AQUEOUS EXTRACT OF

TRITICUM VULGARE

Box x 1 tube x

32g

FARMACEUTICI DAMOR

SPA - ITALI

FARMACEUTICI DAMOR SPA

- ITALI

REGJ

307/07.05.2013 8.36

579 FITOSTIMOLINE

Gauzes

impregnated x

15%

AQUEOUS EXTRACT OF

TRITICUM VULGARE

Box x 10

gauzes x 10cm

x 10cm

FARMACEUTICI DAMOR

SPA - ITALI

FARMACEUTICI DAMOR SPA

- ITALI

REGJ

307/07.05.2013 8.8

580 FITOSTIMOLINE Ovules x 600mg

AQUEOUS EXTRACT OF

TRITICUM VULGARE Box x 6 ovules

FARMACEUTICI DAMOR

SPA - ITALI

FARMACEUTICI DAMOR SPA

- ITALI; GRUNENTHAL

PHARMA AG - ZVICER

REGJ

307/07.05.2013 9.74

581 SULIDAMOR

Powder for oral

suspension x

100mg NIMESULIDE Box x 30 bags

FARMACEUTICI DAMOR

SPA - ITALI

FARMACEUTICI DAMOR SPA

- ITALI; LAMP S. PROSPERO

SPA - ITALI

REGJ

331/29.08.2011 3.14

582 ACY

Ophtalmic ointment

x 30mg/g ACYCLOVIR

Box x tube x

4.5g FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ

167/19.04.2012 4.4

Page 85

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86

583 KETOFTIL

Eye drops solution

x 0.05%

KETOTIFEN FUMARATE X

0.069G/100G (EQ. TO

KETOTIFEN X 0.05G/100G)

Box x 1 flacon x

10ml FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ

351/31.07.2012 3.46

584 KETOFTIL

Ophthalmic gel x

0.05%

KETOTIFEN FUMARATE X

0.069G/100G (EQ. TO

KETOTIFEN X 0.05G/100G)

Box x 1 tube x

10g FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ

351/31.07.2012 3.46

585 LACRINORM

Ophtalmic gel x

(0.01% + 0.2%)

BENZALKONIUM

CHLORIDE + CARBOPOL

980 (POLIACRILIC ACID)

Box x 1 tube x

10g FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ.

455/06.08.2010 2.83

586

NAFLOXEye drops solution

x 0.3 %NORFLOXACIN

Box x 1 flacon x

10 mlFARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

REGJ.

581/27.10.20083.08

587 PIRFALIN

Powder and

solvent for eye

drops solution x

0.005%

SODIUM PIRENOXINE x

0.376mg/7ml

Box x (1 vial of

powder + 1 vial

of 7ml solvent) FARMIGEA SPA - ITALI

FARMIGEA SPA - ITALI;

ALFA WASSERMANN SPA -

ITALI

RIREGJ.

713/21.12.2009 5.59

588 SOLPRENE

Eye drops solution

x 0.55% + 0.35%

PREDNISOLONE SODIUM

PHOSPHATE + NEOMYCIN

SULFATE EQ. TO

NEOMYCIN

Box x 1

polyethylene

measured

dropper bottle x

5ml FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ.

71/09.02.2010 2.83

589 TROPIMIL

Eye drops solution

x 0.5% TROPICAMIDE

Box x 1

polyethylene

measured

dropper bottle x

5ml FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ.

71/09.02.2010 2.89

590 VIT A N

Ophthalmic

ointment x

25000U.I./100g RETINOL ACETATE

Box x 1 tube x

5g FARMIGEA SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ.

78/11.02.2010 3.33

591 MECLON

Ovules x (100mg +

500mg)

CLOTRIMAZOLE +

METRONIDAZOLE Box x 10

ALFA WASSERMANN

SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

RIREGJ

334/20.05.2013 5.66

592 MECLON

Vaginal cream x

(20g + 4g)/100g

METRONIDAZOLE +

CLOTRIMAZOLE

Box x tube x

30g + 6

applicators

ALFA WASSERMANN

SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ

334/20.05.2013 5.66

Page 86

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87

593 MECLON

Vaginal solution x

(200mg/10ml +

1g/130ml)

CLOTRIMAZOLE +

METRONIDAZOLE

Box x 5 flacons

x 10ml + 5

flacons x 130ml

+ 5 canules

ALFA WASSERMANN

SPA - ITALI

ALFA WASSERMANN SPA -

ITALI

RIREGJ

334/20.05.2013 10.31

594 TETRAMIL

Eye drops solution

x (0.3% + 0.05%)

w/v

PHENIRAMINE MALEATE +

TETRYZOLINE

HYDROCHLORIDE

Box x 1 flacon x

10ml

ALFA WASSERMANN

SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ

336/20.07.2012 3.08

595 TROFOGIN

Vaginal cream x

0.5mg

(12.5mg/100g) ESTRIOL

Box x (1 tube x

30g + 6

applicators)

ALFA WASSERMANN

SPA - ITALI FARMIGEA SPA - ITALI

RIREGJ.

71/09.02.2010 5.03

596 AMIKAN

Solution for I.M

injection x

500mg/2ml

AMIKACIN (as AMIKACIN

SULFATE x 667.5mg/2ml)

Box x 1 flacon x

2ml

SO.SE. PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

RIREGJ.

71/09.02.2010 1.89

597 AMIKAN

Solution for I.M

injection x

1000mg/4ml

AMIKACIN (as AMIKACIN

SULPHATE x 1335mg/4ml)

Box x 1 flacon x

4ml

SO.SE. PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

RIREGJ.

291/06.05.2010 2.33

598 AMOSOL

Dispersible tablets

x 1g

AMOXICILLIN ( AS

AMOXICILLIN TRIHYDRATE

x 1148 mg) Box x 12

SO.SE PHARM SRL -

ITALI

LA.FA.RE SRL - ITALI,

FRANCIA FARMACEUTICI

INDUSTRIA FARMACO

BIOLOGICA SRL - ITALI

REGJ.

192/19.03.2009 3.46

599 BATIXIM

Powder and

solvent for solution

for injection I.M. x

1g/4ml

CEFOTAXIME (as

CEFOTAXIME SODIUM X

1.048G/4ML)

Box x (1flacon

of powder + 1

ampoule of

solvent x 4ml)

SO.SE.PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCT'S LINE

S.P.A. - ITALI,

LABORATORIO

FARMACEUTICO CT SRL -

ITALI

RIREGJ.

636/13.11.2008 3.39

600 BATIXIM

Powder and

solvent for solution

for I.V. injection x

1g/4ml

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1.048g)

Box x (1 flacon

of powder + 1

ampoule of

water for

injection x 4ml)

SO.SE. PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI; LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI

RIREGJ.

672/08.12.2009 3.39

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88

601 BART

Coated tablets x

20mg TENOXICAM Box x 30

SO.SE.PHARM S.R.L.

SOCIETA DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

EDMOND PHARMA SRL -

ITALI; SPECIAL PRODUCT'S

LINE SPA - ITALI; BIOLAB

SPA - ITALI

REGJ

331/29.08.2011 4.9

602 BERNY

Granules for oral

solution x

3g/sachet

FOSFOMYCIN (as

FOSFOMYCIN

TROMETAMOL x

5.631g/sachet ) Box x 2 sachets

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI; LA.FA.RE SRL -

ITALI REGJ. 74/01.03.2011 5.97

603 CETERIS

Oral drops, solution

x 10mg/ml

CETIRIZINE

DIHYDROCHLORIDE

Box x 1 glass

bottle x 20ml

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI REGJ. 74/01.03.2011 3.14

604 FRIMAIND

Film coated tablets

x 20mg CITALOPRAM Box x 28 tabs

"SO.SE.PHARM S.R.L." -

ITALI

"SPECIAL PRODUCT'S LINE

S.P.A." - ITALI

RIREGJ

372/27.09.2011 6.41

605 HOMER

Powder for oral

suspension x

(875mg +

125mg)/bag

AMOXICILLIN (as

AMOXICILLIN

TRIHYDRATE) +

CLAVULANIC ACID (as

POTASSIUM

CLAVULANATE) Box x 12 bags

SO.SE.PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

LABORATORIO REIG JOFRE

SA - SPANJE REGJ. 74/01.03.2011 5.97

606 INASAL

Oral and nebulizer

drops solution x

(0.375% +

0.075%)

SALBUTAMOL (SULPHATE)

+ IPRATROPIUM

(BROMIDE)

Box x plastic

flacon x 15ml

SO.SE. PHARM SRL -

ITALI

SPECIAL PRODUCT´S LINE

SPA - ITALI

REGJ

359/28.05.2013 4.43

607 METILBETASONE

Powder and

solvent for solution

for I.M. injection x

80mg/1.5ml

METHYLPREDNISOLONE

SODIUM SUCCINATE

Box x 3

ampoules with

powder + 3

ampoules with

solvent x 1.5ml

SO.SE.PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI; BIOLOGICI

ITALIA LABORATORIES SRL -

ITALI

REGJ

208/07.05.2012 5.59

608 MUCOCIS

Syrup for children x

2g/100ml CARBOCISTEINE

Box x 1 glass

bottle x 200ml

SO.SE. PHARM SRL -

ITALI

SPECIAL PRODUCTS LINE

SPA - ITALI

RIREGJ

506/6.12.2011 3.65

609 MUCOCIS Syrup x 5g/100ml CARBOCYSTEIN

Box x glass

bottle x 200ml

SO.SE. PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

RIREGJ.

446/03.08.2010 3.65

Page 88

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89

610 TOTTIZIM

Powder and

solvent for solution

for IV injection x

1g/vial

CEFTAZIDIME

PENTAHYDRATE X

1164.8mg EQUIVALENT TO

1000mg CEFTAZIDIME AND

WATER FOR INJECTABLE

PREPARATIONS AS

SOLVENT x 10ml

Box x 1 vial of

powder + 1

ampoule x 10ml

of water for

injection

"SO.SE.PHARM S.R.L." -

ITALI

"SPECIAL PRODUCT'S LINE

S.P.A."- ITALI

RIREGJ

372/27.09.2011 5.22

611 TOTTIZIM

Powder and

solvent for solution

for IM injection x

1g/vial

CEFTAZIDIME

PENTAHYDRATE X

1164.8mg EQUIVALENT TO

1000mg CEFTAZIDIME AND

WATER FOR INJECTABLE

PREPARATIONS AS

SOLVENT x 3ml

Box x 1 vial of

powder + 1

ampoule x 3ml

of water for

injection

"SO.SE.PHARM S.R.L." -

ITALI

"SPECIAL PRODUCT'S LINE

S.P.A." - ITALI

RIREGJ

372/27.09.2011 5.22

612 KEVINDOL

Solution for IM, IV

injection x 30mg/ml

KETOROLAC

TROMETAMOL

Box x 3

ampoules x 1ml

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI REGJ. 74/01.03.2011 2.83

613 KEVINDOL

Oral drops, solution

x 20mg/ml

KETOROLAC

TROMETAMOL

Box x 1 glass

bottle x 10ml

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI REGJ. 74/01.03.2011 5.34

614 LOSS

Film-coated tablets

x 70mg

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE x 91.35mg) Box x 4

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI; WEST PHARMA

SA - PORTUGALI

REGJ.

140/15.04.2011 9.11

615 WINCH

Hard capsules x

200mg FLUCONAZOLE Box x 7

SO.SE.PHARM SRL -

ITALI

LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI; GET SRL - ITALI REGJ. 74/01.03.2011 9.55

616 SOSEFEN

Oral drops, solution

x 2mg/ml

KETOTIFEN (as

KETOTIFEN FUMARATE)

Box x 1 glass

bottle x 20ml

SO.SE. PHARM SRL

SOCIETA DI SERVIZIO

PER L"INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCTS LINE

SPA - ITALI

RIREGJ

506/6.12.2011 3.9

617 UTICINA

Coated tablets x

400mg NORFLOXACIN Box x 14

SO.SE. PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

RIREGJ

50/04.02.2013 3.46

Page 89

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90

618 SIRTAP

Powder for solution

for injection (I.M.) x

1g/3.5ml

CEFTRIAXONE (as

CEFTRIAXONE DISODICO

3.5H2O x 1.193MG)

Box x 1 vial with

powder + 1

ampoule with

solvent x 3.5ml

SO.SE.PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCT`S LINE

S.P.A - ITALI

RIREGJ

468/03.09.2013 5.08

619 SIRTAP

Powder for solution

for injection (I.M.) x

500mg/2ml

CEFTRIAXONE (as

CEFTRIAXONE DISODICO

3.5H2O x 569.5MG)

Box x 1 vial with

powder + 1

ampoule with

solvent x 2ml

SO.SE.PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCT`S LINE

S.P.A - ITALI

RIREGJ

468/03.09.2013 3.91

620 SANECOL

Film-coated tablets

x 200mg RIFAXIMIN Box x 12

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ

208/07.05.2012 4.52

621 TROZAMIL

Film-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.1mg) Box x 3

SO.SE.PHARM SRL -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ

208/07.05.2012 4.78

622 DOMES

Orodispersible

tablets x 100mg NIMESULIDE Box x 30

SO.SE. PHARM SRL

SOCIETA' DI SERVIZIO

PER L'INDUSTRIA

FARMACEUTICA ED

AFFINI - ITALI

SPECIAL PRODUCT'S LINE

S.P.A. - ITALI

REGJ.

647/25.11.2009 2.77

623 FERRO COMPLEX

Effervescent

granules x

80mg/sachet

Fe++ (as FERROUS

GLUCONATE X

695mg/sachet)

Box x 30

sachets PHARMAFAR SRL - ITALI LA.FA.RE. SRL - ITALI

REGJ

208/07.05.2012 8.04

624 PIGENIL

Soft capsules x

50mg

EXTRACT OF PYGEUM

AFRICANUM Box x 30 PHARMAFAR SRL - ITALI

CATALENT ITALY SPA -

ITALI

REGJ

45/30.01.2012 13.2

625 TRINITRINA

Concentrate for

solution for infusion

x 5mg/1.5ml GLYCERYL TRINITRATE

Box x 10

ampoules x

1.5ml

ACARPIA-SERVICOS

FARMACEUTICOS LDA -

PORTUGALI FISIOPHARMA SRL - ITALI

REGJ

45/30.01.2012 12.57

626 TRINITRINA

Concentrate for

solution for infusion

x 50mg/50ml GLYCERYL TRINITRATE

Box x 5

ampoules x

50ml

ACARPIA-SERVICOS

FARMACEUTICOS LDA -

PORTUGALI FISIOPHARMA SRL - ITALI

REGJ

45/30.01.2012 35.82

627

COLCHICINA

LIRCA Tablets x 1mg CHOLCHICINE Box x 60

ACARPIA-SERVICOS

FARMACEUTICOS LDA -

PORTUGALI

GALENICA SA - GREQI;

KLEVA SA - GREQI

REGJ

45/30.01.2012 7.23

Page 90

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91

628 FLEBOSIDE

Coated tablets x

(3mg + 300mg)

CARBAZOCHROME +

TROXERUTIN Box x 30

ACARPIA-SERVICOS

FARMACEUTICOS LDA -

PORTUGALI

GALENICA S.A. - GREQI;

KLEVA S.A. - GREQI

RIREGJ.

96/16.03.2011 8.92

629 FLEBOSIDE

Solution for I.M.

injection x (1.5mg +

150mg)/3ml

CARBAZOCHROME +

TROXERUTIN

Box x 10

ampoules x 3ml

ACARPIA-SERVICOS

FARMACEUTICOS LDA -

PORTUGALI

GALENICA S.A. - GREQI;

KLEVA S.A. - GREQI

RIREGJ.

96/16.03.2011 9.8

630

LENIL

ANTIPRURITO Cream x 2%

PROMETHAZINE (as

PROMETHAZINE

HYDROCHLORIDE x

2.26g/100g)

Box x tube x

30g

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

RIREGJ

380/13.08.2012 1.63

631

LIDOCAINA

CLORIDRATO E

IDROCORTISONE

ACETATO ZETA

Cream x (1.5% +

1%) w/w

LIDOCAINE

HYDROCHLORIDE +

HYDROCORTISONE

ACETATE

Box x tube x

30g

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

RIREGJ

260/12.06.2012 2.89

632

ICTAMMOLO

ZETA 10% Ointment x 10% ICHTHAMMOL

Box x 1 tube x

30g

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

RIREGJ.

488/10.09.2010 1.01

633

MERBROMINA

ZETA 2%

Cutaneous solution

x 2% MERBROMIN

Box x flacon x

30ml

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

RIREGJ.

488/10.09.2010 1.51

634 MENTOLO ZETA

Cutaneous powder

x 1% (w/w) MENTHOL

Box x flacon x

100g

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

REGJ

422/11.07.2013 1.46

635

GLICEROLO ZETA

2.25 G

Rectal solution for

infants x 2.25g GLICEROL

Box x 6

monodose

containers

(microclismi) x

3g

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

RIREGJ

260/12.06.2012 1.51

636 ZETALAX

Suppositories x

2.25g GLYCERIN Box x 18

ZETA FARMACEUTICI

SPA - ITALI

ZETA FARMACEUTICI SPA -

ITALI

RIREGJ.

488/10.09.2010 1.23

637 IVOR

Solution for

injection x 2500 IU

Anti-Xa/0.2ml BEMIPARIN SODIUM

Box x 2 pre-

filled syringes x

0.2ml VIANEX SA - GREQI

LABORATORIOS

FARMACEUTICOS ROVI SA -

SPANJE

RIREGJ

297/18.07.2011 3.85

638 IVOR

Solution for

injection x 2500 IU

Anti-Xa/0.2ml BEMIPARIN SODIUM

Box x 10 pre-

filled syringes x

0.2ml VIANEX SA - GREQI

LABORATORIOS

FARMACEUTICOS ROVI SA -

SPANJE

RIREGJ

297/18.07.2011 14.5

Page 91

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92

639 IVOR

Solution for

injection x 3500 IU

Anti-Xa/0.2ml BEMIPARIN SODIUM

Box x 2 pre-

filled syringes x

0.2ml VIANEX SA - GREQI

LABORATORIOS

FARMACEUTICOS ROVI SA -

SPANJE

RIREGJ

297/18.07.2011 5.9

640 IVOR

Solution for

injection x 3500 IU

Anti-Xa/0.2ml BEMIPARIN SODIUM

Box x 10 pre-

filled syringes x

0.2ml VIANEX SA - GREQI

LABORATORIOS

FARMACEUTICOS ROVI SA -

SPANJE

RIREGJ

297/18.07.2011 19.8

641 IVOR

Solution for

injection x 3500 IU

Anti-Xa/0.2ml BEMIPARIN SODIUM

Box x 30

prefilled

syringes x 0.2ml

for hospital use

only VIANEX SA - GREQI

LABORATORIOS

FARMACEUTICOS ROVI SA -

SPANJE

RIREGJ

297/18.07.2011 71.9

642 IVORMAX

Solution for

injection x 25000IU

Anti-Xa/ml

BEMIPARIN SODIUM

(5000IU Anti-Xa/0.2ml)

Box x 2 pre-

filled syringes x

0.2ml VIANEX SA - GREQI

ROVI CONTRACT

MANUFACTURING SL -

SPANJE

RIREGJ

450/31.10.2011 8.6

643 CARBOPLAN

Solution for

infusion x

150mg/15ml vial CARBOPLATIN

Box x 1 vial x

15ml VIANEX SA - GREQI VIANEX SA - GREQI REGJ. 98/22.02.2010 27

644 CARBOPLAN

Solution for

infusion x

450mg/45ml vial CARBOPLATIN

Box x 1 vial x

45ml VIANEX SA - GREQI VIANEX SA - GREQI REGJ. 98/22.02.2010 77

645 SEPTAX

Powder for solution

for injection x

1g/vial

CEFTAZIDIME (as

CEFTAZIDIME

PENTAHYDRATE x 1.16g) Box x 1 vial VIANEX SA - GREQI VIANEX SA - GREQI

RIREGJ.

165/24.03.2010 3.7

646 SALONPAS

Plaster x (1.32 +

1.2 + 0.26 + 0.42)

mg/cm2

METHYL SALICYLATE + L-

MENTHOL + DL-CAMPHOR

+ TOCOPHEROL ACETATE

Box x 10

pachets x

(6.5cm x 4.2cm) VIANEX SA - GREQI

VIANEX SA - GREQI;

HISAMITSU

PHARMACEUTICAL CO.INC -

JAPONI

RIREGJ

471/11.11.2011 1.8

647 LORDIN

Powder and

solvent for solution

for injection x

40mg/vial

OMEPRAZOLE (as

OMEPRAZOLE SODIUM x

42.6mg)

Box x 1 vial with

powder + 1

ampoule with

solvent VIANEX SA - GREQI VIANEX SA - GREQI

RIREGJ.

165/24.03.2010 3.7

Page 92

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93

648 ONDA

Film-coated tablets

x 8mg

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE x 10mg) Box x 15 VIANEX SA - GREQI VIANEX SA - GREQI

RIREGJ.

235/07.06.2011 24

649 ONDA

Solution for

injection x 4mg/2ml

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE x 2.5mg/ml)

Box x 1

ampoule x 2ml VIANEX SA - GREQI VIANEX SA - GREQI

RIREGJ.

235/07.06.2011 4

650 ONDA

Solution for

injection x 8mg/4ml

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE x 2.5mg/ml)

Box x 1

ampoule x 4ml VIANEX SA - GREQI VIANEX SA - GREQI

RIREGJ.

235/07.06.2011 4.25

651 PATAXEL

Concentrate for

solution for infusion

x 6mg/1ml PACLITAXEL Box x 5ml vial VIANEX SA - GREQI VIANEX SA - GREQI

REGJ.

396/07.07.2009 40

652 PATAXEL

Concentrate for

solution for infusion

x 6mg/1ml PACLITAXEL Box x 50ml vial VIANEX SA - GREQI VIANEX SA - GREQI

REGJ.

396/07.07.2009 210

653 PATAXEL

Concentrate for

solution for infusion

x 6mg/1ml PACLITAXEL

Box x 16.7ml

vial VIANEX SA - GREQI VIANEX SA - GREQI

REGJ.

396/07.07.2009 95

654 RIBEX

Film-coated tablets

x 4mg RISPERIDONE Box x 20 VIANEX SA - GREQI VIANEX SA - GREQI

RIREGJ

167/19.04.2012 5.5

655 VOXIN

Powder for solution

for infusion x

1g/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE X

1.025g/vial) Box x 1 vial VIANEX SA - GREQI VIANEX SA - GREQI

REGJ

331/29.08.2011 7.3

656 PRICEFIL

Powder for oral

suspension x

250mg/5ml

CEFPROZIL (as

CEFPROZIL

MONOHYDRATE x

52.31mg/ml)

Box x 1 plastic

bottle x 100ml VIANEX SA - GREQI VIANEX SA - GREQI

REGJ

334/29.08.2011 5.65

657 PRICEFIL

Film coated tablets

x 500mg

CEFPROZIL (as

CEFPROZIL

MONOHYDRATE x

523.10mg) Box x 12 VIANEX SA - GREQI VIANEX SA - GREQI

REGJ

334/29.08.2011 6.15

Page 93

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94

658 GEMNIL

Powder for solution

for infusion x

200mg/vial

GEMCITABINE (as

GEMCITABINE

HYDROCHLORIDE X

228mg/vial) Box x 1 vial VIANEX SA - GREQI VIANEX SA - GREQI

REGJ

331/29.08.2011 9.6

659 GEMNIL

Powder for solution

for infusion x

1000mg/vial

GEMCITABINE (as

GEMCITABINE

HYDROCHLORIDE X

1140mg/vial) Box x 1 vial VIANEX SA - GREQI VIANEX SA - GREQI

REGJ

331/29.08.2011 45.7

660 PENNSAID

Cutaneous solution

x 1.5% (w/w)

DICLOFENAC SODIUM (eq.

to 16.05mg/1ml)

Box x 1 plastic

bottle x 30ml VIANEX SA - GREQI

NUVO

MANUFACTURING/FABRICA

TION NUVO - KANADA

REGJ

334/29.08.2011 7.3

661 BRUNAC

Eye drops, solution

x 5% ACETYLCISTEINE

Box x 1 plastic

measured

dropper bottle x

5ml

BRUSCHETTINI S.R.L. -

ITALI

BRUSCHETTINI S.R.L. -

ITALI; PHARMASTER, Z.I. -

FRANCE

RIREGJ.

647/10.12.2010 3.4

662 PIROFTAL

Eye drops solution

x 0.5% PIROXICAM

Box x 1 plastic

measured

dropper bottle x

10ml

BRUSCHETTINI S.R.L. -

ITALI BRUSCHETTINI S.R.L. - ITALI

RIREGJ.

602/05.11.2010 2.28

663 EQUITON

Eye drops solution

x (0.5% + 0.1%)

TIMOLOL MALEATE +

PILOCARPINE

HYDROCHLORIDE

Box x 1 plastic

measured

dropper bottle x

5ml

BRUSCHETTINI S.R.L. -

ITALI BRUSCHETTINI S.R.L. - ITALI

RIREGJ.

602/05.11.2010 3.04

664 LACRISOL

Eye drops solution

x (0.0045% +

0.5%) w/v

BENZALKONIUM

CHLORIDE +

HYDROXYPROPYLMETHYL

CELLULOSE

Box x 1 vial x

10ml

BRUSCHETTINI SRL -

ITALI BRUSCHETTINI SRL - ITALI

REGJ

61/06.02.2013 1.5

665 IPSOFLOG

Solution for

injection x

20mg/1ml PIROXICAM

Box x 6

ampoules

TECNOPHARMA S.R.L. -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

192/19.03.2009 6

666 IPSOFLOG Cream x 1% PIROXICAM

Box x 1 tube x

50g

TECNOPHARMA S.R.L. -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

192/19.03.2009 6

Page 94

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95

667 QARI

Film-coated tablets

x 200mg

RUFLOXACINE

HYDROCHLORIDE Box x 6

MEDIOLANUM

FARMACEUTICI SPA -

ITALI

MEDIOLANUM

FARMACEUTICI SPA - ITALI;

DOPPEL FARMACEUTICI

SRL - ITALI

RIREGJ

325/15.05.2013 12

668 KOCEFAN

Powder and

solvent for solution

for IM injection x

1g/3.5ml

CEFTRIAXONE (as

BISODIUM CEFTRIAXONE x

3.5H2O x 1.193g)

Box x 1 flacon

with powder + 1

flacon with

solvent x 3.5ml

MEDIOLANUM

FARMACEUTICI SPA -

ITALI

LABORATORIO

FARMACEUTICO CT SRL -

ITALI; MITIM SRL - ITALI

RIREGJ

325/15.05.2013 4.8

669 VELAMOX

Dispersible tablets

x 1g

AMOXICILLIN (as

AMOXICILLIN TRIHYDRATE

x 1148mg) Box x 12

MEDIOLANUM

FARMACEUTICI SPA -

ITALI MITIM SRL - ITALI

REGJ.

421/29.07.2009 4

670 VELAMOX

Powder for oral

suspension x

250mg/7ml

AMOXICILLIN TRIHYDRATE

x 8.75g/100g powder

Box x 1 flacon x

100ml + dosage

spoon

MEDIOLANUM

FARMACEUTICI SPA -

ITALI MITIM SRL - ITALI

REGJ.

421/29.07.2009 4

671 FERRO TRE

Oral solution x

2g/10ml

IRON ACETYL

TRANSFERINE

HYDROGLYCERIC

SOLUTION (corresp. To

40mg FE³

)

Box x 10 single

dose containers

x 10ml

MEDIOLANUM

FARMACEUTICI SPA -

ITALI

DOPPEL FARMACEUTICI

SRL - ITALI; MEDIOLANUM

FARMACEUTICI SPA - ITALI;

ABC FARMACEUTICI SPA -

ITALI

RIREGJ

334/20.05.2013 6

672 DIFRAREL E

Coated tablets x

(50 mg + 50 mg)

MYRTILLUS

ANTHOCYANOSIDES

EXTRACT + ALPHA-

TOCOPHEROL ACETATE

CONCENTRATE Box x 24

LABORATOIRES

LEURQUIN

MEDIOLANUM - FRANCE

LABORATOIRES LEURQUIN

MEDIOLANUM - FRANCE;

CENEXI - FRANCE

REGJ.

197/25.03.2009 4.5

673 DIFRAREL

Coated tablets x

(100 mg + 5 mg)

VACCINIUM MYRTILLUS

ANTHOCYANOSIDES

EXTRACT + BETA-

CAROTENE Box x 20

LABORATOIRES

LEURQUIN

MEDIOLANUM - FRANCE

LABORATOIRES LEURQUIN

MEDIOLANUM - FRANCE;

CENEXI - FRANCE

REGJ.

197/25.03.2009 4.5

Page 95

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96

674 VAGOSTABYL

Coated tablets x

(50 mg + 45 mg +

10 mg + 50 mg)

DRIED HYDROALCOHOLIC

EXTRACT OF CRATAEGUS

+ DRIED

HYDROALCOHOLIC

EXTRACT OF MELISSA +

MAGNESIUM

THIOSULPHATE +

CALCIUM LACTATE

PENTAHYDRATE Box x 40

LABORATOIRES

LEURQUIN

MEDIOLANUM - FRANCE CENEXI - FRANCE

REGJ.

197/25.03.2009 4

675 MUXOL

Oral solution x

0.3%

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 180ml BIOCODEX - FRANCE BIOCODEX - FRANCE

REGJ

422/11.07.2013 2.6

676 FLUCACID Tablets x 1g

FLUCLOXACILLINE

SODIUM MONOHYDRATE X

1088MG (EQUIVALENT TO

FLUCLOXACILLINE X 1G) Box x 12

EURO-PHARMA SRL -

ITALI

FRANCIA FARMACEUTICI

SRL - ITALI

RIREGJ.

446/26.08.2009 8

677

CEFAZOLINA

PHARMABER

Powder and

solvent for solution

for I.M injection x

1000mg/vial

CEFAZOLINE (as

CEFAZOLINE SODIUM x

1050mg/vial)

Box x 1 vial of

powder + 1 vial

of solvent

(Lidocaine

hydrochloride) x

4ml

PHARMABER S.R.L. -

ITALI

SPECIAL PRODUCTS LINE

SPA - ITALI

REGJ

527/23.12.2011 1.2

678 SILMAR

Hard capsules x

200 mg

EXTRACT OF SILYBUM

MARIANUM CONTAINING

FLAVONOIDS EXPRESSED

AS SILYMARIN Box x 30

PHARMABER S.R.L. -

ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

181/18.03.2009 9

679

AFACORTOintment x (0.5% +

0.1%)

NEOMYCIN (EQ. TO

NEOMYCIN SULPHATE x

8.3mg/g) +

DEXAMETHASONE

Box x 1 tube x

20g

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

489/10.09.2010

2.6

680 AMIKAN

Solution for

injection x

500mg/2ml

AMIKACIN (as AMIKACIN

SULPHATE)

Box x 1 vial x

2ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

109/01.03.2013 1.6

Page 96

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97

681 APRINOL Syrup x 15mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 125ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

713/21.12.2009 2.8

682 APRINOL Syrup x 30mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 125ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

260/12.06.2012 2.8

683

ARISTIN-C

Solution for

infusion x

100mg/10ml

CIPROFLOXACIN

Box x 5

ampoules x

10ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

109/01.03.20136.3

684 ARISTIN-C

Solution for

infusion x

200mg/100ml

CIPROFLOXACIN (as

CIPROFLOXACIN LACTATE

x 2.54mg/ml)

Box x 1 vial x

100ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

109/01.03.2013 7.5

685 ARISTIN-C

Solution for

infusion x

400mg/200ml

CIPROFLOXACIN (as

CIPROFLOXACIN LACTATE

x 2.54mg/ml)

Box x 1 glass

bottle x 200ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

207/07.05.2012 15

686 CARNIL

Oral solution x

1g/10ml vial LEVOCARNITINE

Box x 10 vials x

1g

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

489/10.09.2010 8.5

687 DIGOXIN/ANFARM

Solution for

injection x

0.5mg/2ml DIGOXIN

Box x 6

ampoules x 2ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

489/10.09.2010 6

688

DOPAMINE/ANFA

RM

Concenrtate for

solution for infusion

x 50mg/5ml

DOPAMINE

HYDROCHLORIDE

Box x 5

ampoules x 5ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

489/10.09.2010 8

689

ESELAN

Powder and

solvent for solution

for injection x

40mg/vial

OMEPRAZOLE (as

OMEPRAZOLE SODIUM x

42.6mg/10ml)

Box x 1 vial + 1

amp. solvent x

10ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

578/02.11.2009

5.5

690 FLUSEMINAL

Film-coated tablets

x 400mg NORFLOXACIN Box x 14

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

109/01.03.2013 5

691 FLUSENIL

Hard capsules x

50mg FLUCONAZOLE Box x 7

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

291/06.05.2010 6.2

692 ICONAL Tablets x 15mg MELOXICAM Box x 30

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

213/09.05.2012 5

693

MAXILIN

Powder for solution

for infusion x

500mg/vial

CLARITHROMYCIN Box x 1 vialANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

582/29.10.2010

15

Page 97

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98

694

MEROPENEM /

ANFARM

Powder for solution

for injection /

infusion x

500mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 570mg/vial)

Box x 10 vials

(for hospital

use)

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

528/23.12.2011 120

695

MEROPENEM /

ANFARM

Powder for solution

for injection /

infusion x

500mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 570mg/vial) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

528/23.12.2011 12

696

MEROPENEM /

ANFARM

Powder for solution

for injection /

infusion x

1000mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x

1140mg/vial)

Box x 10 vials

(for hospital

use)

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

528/23.12.2011 150

697

MEROPENEM /

ANFARM

Powder for solution

for injection /

infusion x

1000mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x

1140mg/vial) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

528/23.12.2011 15

698 NEO-ENDUSIX

Lyophilised powder

and solvent for

solution for

injection x

20mg/2ml TENOXICAM

Box x 1 glass

vial of powder +

1 ampoule of

solvent (water

for injection) x

2ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

260/12.06.2012 1.8

699 NEO-ENDUSIX

Film-coated tablets

x 20mg TENOXICAM Box x 10

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

260/12.06.2012 4

700 NIPOGALIN

Powder for solution

for injection x

750mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM x

909.1mg/vial) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

109/01.03.2013 2.7

701 NIPOGALIN

Powder for solution

for injection x

1.5g/vial

CEFUROXIME (as

CEFUROXIME SODIUM x

1818.2mg/vial) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

109/01.03.2013 4

Page 98

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99

702 NIPOGALIN

Film-coated tablets

x 250mg

CEFUROXIME (as

CEFUROXIME AXETIL x

300.72mg) Box x 14

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

379/10.08.2012 9

703 NIPOGALIN

Film-coated tablets

x 500mg

CEFUROXIME (as

CEFUROXIME AXETIL x

601.44mg) Box x 8

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

379/10.08.2012 9

704 NEO-SUXIGAL

Film-coated tablets

x 150mg ROXITHROMYCIN Box x 10

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

291/06.05.2010 8

705 NIMEDINE

Powder for solution

for infusion x

(500mg +

500mg)/vial

IMIPENEM (as IMIPENEM

MONOHYDRATE x

530mg/vial) + CILASTATIN

(as CILASTATIN SODIUM x

530mg/vial)

Box x 10 glass

vials (only for

hospital use)

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

207/07.05.2012 150

706 NIMEDINE

Powder for solution

for infusion x

(500mg +

500mg)/vial

IMIPENEM (as IMIPENEM

MONOHYDRATE x

530mg/vial) + CILASTATIN

(as CILASTATIN SODIUM x

530mg/vial) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

207/07.05.2012 15

707 RIDON Tablets x 70mg

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE x 91.37mg) Box x 4

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

213/09.05.2012 12

708 STOPAREN

Dry powder and

solvent for solution

for IV injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1040mg)

Box x 1 vial of

powder + 1

ampoule of

solvent x 4ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

325/15.05.2013 3.7

709 STOPAREN

Dry powder and

solvent for solution

for IM injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1040mg)

Box x 1 vial of

powder + 1

ampoule of

solvent x 4ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

325/15.05.2013 3.7

Page 99

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100

710 SUFIGAL

Powder for oral

solution x

1.5g/sachet

GLUCOSAMINE SULFATE

(as GLUCOSAMINE

SULFATE SODIUM SALT x

1.884mg/sachet)

Box x 30

sachets

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

186/26.04.2012 15

711 TRAVILAN

Dry powder for IV

injection x

1000mg/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM x

1250mg)

Box x 1 vial of

powder + 1

ampoule of

solvent x 10ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

325/15.05.2013 4.4

712 TRAVILAN

Dry powder for IM

injection x

1000mg/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM x

1250mg)

Box x 1 vial of

powder + 1

ampoule of

solvent x 3.5ml

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

325/15.05.2013 4.4

713 ULCERON

Powder for solution

for I.V. Injection x

40mg/vial

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM x

42.3 mg/vial)

Box x 5 vials (for

hospital use)

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

207/07.05.2012 35

714 ULCERON

Powder for solution

for I.V. Injection x

40mg/vial

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM x

42.3 mg/vial) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

207/07.05.2012 7

715 VEROXIL Tablets x 20mg

LISINOPRIL (as LISINOPRIL

DIHYDRATE) Box x 14

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ

109/01.03.2013 5.9

716 ZITHROTEL

Powder for solution

for infusion x

500mg/vial

AZITHROMYCIN (AS

AZITHROMYCIN

DIHYDRATE x 524.1mg) Box x 1 vial

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

RIREGJ.

582/29.10.2010 12

717 ZITHROTEL

Film-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524mg) Box x 3

ANFARM HELLAS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ

186/26.04.2012 5

718

CEFIXIMA

NEOCEF

Powder for oral

suspension x

100mg/5ml CEFIXIME

Box x 1 glass

bottle x 120ml

LABORATORIOS ATRAL

SA - PORTUGALI

LABORATORIOS ATRAL SA -

PORTUGALI (APL:

LABORATORIOS ATRAL SA -

PORTUGALI)

REGJ

452/31.10.2011 10

Page 100

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101

719

DEFLAZACORTE

GPTablets x 6mg DEFLAZACORT Box x 20

GP-GENERICOS

PORTUGUESES LDA -

PORTUGALI

FARMALABOR-PRODUTOS

FARMACEUTICOS SA -

PORTUGALI (APL:

LABORATORIO MEDINFAR-

PRODUTOS

FARMACEUTICOS SA -

PORTUGALI)

REGJ.

549/31.10.2012

6.1

720 TRIFENE

Oral suspension x

20mg/ml IBUPROFEN

Box x 1 glass

bottle x 100ml

LABORATORIO

MEDINFAR-PRODUTOS

FARMACEUTICOS SA -

PORTUGALI

FARMALABOR-PRODUTOS

FARMACEUTICOS SA -

PORTUGALI

REGJ

549/31.10.2012 2.7

721

REUMOXICAMSuppository x

20mgPIROXICAM Box x 12

"LABORATORIO

MEDINFAR-PRODUCTOS

FARMAVEUTICOS, S.A."

PORTUGALI

"FARMALABOR-

PRODUCTOS

FARMACEUTICOS S.A"

PORTUGALI

Regj.475/09.09.2013;

Revokuar

U.700/30.12.2013

5.3

722 ALBUTEINE 20%

Solution for

infusion x 0.2g/ml HUMAN ALBUMIN

Box x 1 vial

50ml

INSTITUTO GRIFOLS SA -

SPANJE

INSTITUTO GRIFOLS SA -

SPANJE

RIREGJ

598/26.11.2012 30.5

723 ALBUTEINE 20%

Solution for

infusion x 0.2g/ml HUMAN ALBUMIN

Box x 1 vial

100ml

INSTITUTO GRIFOLS SA -

SPANJE

INSTITUTO GRIFOLS SA -

SPANJE

RIREGJ

598/26.11.2012 61

724 ALBUTEINE 5%

Solution for

infusion x 0.05g/ml HUMAN ALBUMIN

Box x 1 vial

250ml

INSTITUTO GRIFOLS SA -

SPANJE

INSTITUTO GRIFOLS SA -

SPANJE

RIREGJ

598/26.11.2012 38.2

725 ALBUTEINE 5%

Solution for

infusion x 0.05g/ml HUMAN ALBUMIN

Box x 1 vial

500ml

INSTITUTO GRIFOLS SA -

SPANJE

INSTITUTO GRIFOLS SA -

SPANJE

RIREGJ

598/26.11.2012 76.4

726 FLEBOGAMMA

Solucion for

infusion x 5%

(5g/100ml)

HUMAN NORMAL

IMMUNOGLOBULIN

Box x 1 flacon x

100ml

INSTITUTO GRIFOLS S.A.

- SPANJE

INSTITUTO GRIFOLS S.A. -

SPANJE

Riregj.423/11.07.201

3270

727 IGAMPLIA

Solution for

injection x

160mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN

Box x 1

ampoule x 2ml

INSTITUTO GRIFOLS S.A.

- SPANJE

INSTITUTO GRIFOLS S.A. -

SPANJE

RIREGJ

423/11.07.2013 17.3

Page 101

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102

728 ALOPEXY

Cutaneous

Solution x

2g/100ml (2%) MINOXIDIL

Box x (3 flacons

x 60ml + 3

graduated

pipettes + 1

dosage pump)

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

192/19.03.2009 20.4

729 ALOPEXY

Cutaneous solution

x 5 % MINOXIDIL

Box x 3 Bottle x

60 ml

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

715/24.12.2008 28.2

730 CYTEAL

Foaming solution x

(0.1g/100ml +

0.5ml/100ml +

0.3g/100ml)

HEXAMIDINE

DIISETIONATE +

CHLORHEXIDINE

GLUCONATE (solution 20%

w/v) + CHLOROCRESOL Flacon x 250ml

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

RIREGJ

423/11.07.2013 2.43

731 DEXERYL

Cream x (15g + 8g

+ 2g)/100g

GLYCEROL + WHITE SOFT

PARAFFIN + LIQUID

PARAFFIN

Box x tube x

250g

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

309/17.05.2010 3.06

732 ERYFLUID

Solution (Lotion) x

4% ERYTHROMYCIN

Box x 1 flacon x

30ml

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

192/19.03.2009 2

733 MYCOSTER

Topical film -

forming solution x 8

% CICLOPIROX

Box x 1 Bottle x

3 ml

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

715/24.12.2008 8.4

734 MYCOSTER

Cutaneous solution

x 1 % CICLOPIROX OLAMINE

Box x 1 Bottle x

30 ml

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

715/24.12.2008 3.2

735 MYCOSTER Cream x 1 % CICLOPIROX OLAMINE

Box x 1 Tube x

30 g

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

715/24.12.2008 3.2

Page 102

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103

736 MYCOSTER

Cutaneous powder

x 1 % CICLOPIROX OLAMINE

Box x 1 Bottle x

30 g

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

715/24.12.2008 3.2

737 ANESDERM 5%

Cream x (2.5g +

2.5g)/100g LIDOCAINE + PRILOCAINE

Box x 5 tubes x

5g x 10

pansements

adhesifs

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

(establishment Progipharm) -

FRANCE

REGJ.

526/01.10.2010 10

738 LOCATOP Cream x 0.1% DESONIDE x 0.1g/100g

Box x 1 tube x

30g

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

(establishment Progipharm) -

FRANCE

REGJ.

526/01.10.2010 2.2

739 LOCAPRED Cream x 0.1% DESONIDE x 0.1g/100g

Box x 1 tube x

15g

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

(establishment Progipharm) -

FRANCE

REGJ.

526/01.10.2010 1.7

740

FUSIDATE DE

SODIUM PIERRE

FABRE 2% Ointment x 2% SODIUM FUSIDATE

Box x 1 tube x

15g

PIERRE FABRE

DERMATOLOGIE -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

156/20.04.2011 2.14

741 AIROL Cream x 0.05%

TRETINOIN (VITAMIN A -

ACID)

Box x 1 tube x

20g

PIERRE FABRE ITALIA

SPA - ITALI

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

156/20.04.2011 1.87

742

CLOBETASOLO

PIERRE FABRE

Ointment x

500mcg/g

CLOBETASOL

PROPIONATE (eq. to

CLOBETASOL x 440mcg/g)

Box x 1 tube x

30g

PIERRE FABRE ITALIA

SPA - ITALI

PIERRE FABRE

MEDICAMENT PRODUCTION

ETABLISSEMENT

PROGIPHARM - FRANCE

REGJ.

156/20.04.2011 2.17

743 ACIKLOVIR Cream x 5% ACICLOVIR

Box x 1 tube x

5g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

471/31.08.2010 150

744 ADRENALINE

Solution for

injection x 1 mg/ml

EPINEPHRINE

BITARTRATE

Box x 10

ampoules x 1ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

430/24.10.2011 400

Page 103

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104

745 OSTOMAX Tablets x 70mg

ALENDRONIC ACID (as

SODIUM ALENDRONATE

TRIHYDRATE x 91.36mg) Box x 4

PROFARMA SH.A -

SHQIPERI

MIBE GMBH ARZNEIMITTEL -

GJERMANI; PROFARMA

SH.A - SHQIPERI

REGJ.

362/15.06.2010 1200

746 ALGINE

Tablets x (20 mg +

150 mg + 50 mg +

300 mg)

CAFFEINE + PHENACETIN

+ BARBITAL +

AMINOPHENAZONE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 123.6

747 ALKOOL BORIK Solution x 25mg/ml BORIC ACID

Box x flacon x

10ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 96

748 ALUKOL Tablets x 500mg ALUMINIUM HYDROXIDE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

647/10.12.2010 105

749 ANABOFARMA Tablets x 5mg METHANDROSTENOLONE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 300

750 ANABOFARMA Tablets x 5mg METHANDROSTENOLONE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 78

751 ANALGINE

Solution for

injection x 1g/2ml METAMIZOLE SODIUM

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 3800

752

ANTIHEMORROID

ALE

Suppositories x

(0.03g + 0.08g +

0.10g + 0.10g +

0.10g + 0.04g)

EPHEDRINE

HYDROCHLORIDE +

LIDOCAINE

HYDROCHLORIDE +

BISMUTH SUBGALLATE +

ZINC OXIDE + PERU

BALSAM + CASTOR OIL

Box x 10

suppositories

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 200

753 ASPIRINE Tablets x 500mg ACETYLSALICYLIC ACID Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

645/10.12.2010 55.5

754 ATROPINE

Solution for

injection x 1mg/ml ATROPINE SULPHATE

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 4000

Page 104

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105

755 ZITARA

Film coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.04mg) Box x 3

PROFARMA SH.A -

SHQIPERI

MIBE GMBH ARZNEIMITTEL -

GJERMANI; PROFARMA

SH.A - SHQIPERI

REGJ.

362/15.06.2010 510

756 BIKALUTAMID

Film-coated tablets

x 50mg BICALUTAMIDE Box x 30

PROFARMA SH.A -

SHQIPERI

MIBE GMBH ARZNEIMITTEL -

GJERMANI; PROFARMA

SH.A - SHQIPERI

REGJ.

575/28.10.2010 6600

757

BIKARBONAT

NATRIUMI

Solution for

injection x

0.84g/10ml SODIUM BICARBONATE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 526

758

BIKARBONAT

NATRIUMI

Solution for

injection x

0.84g/10ml SODIUM BICARBONATE

, Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 5260

759 BROMHEKSINE Tablets x 8mg

BROMHEXINE

HYDROCHLORIDE Box x 20

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 80

760 BRONAX Syrup x 4mg/5ml

BROMHEXINE

HYDROCHLORIDE

Box x 1 glass

bottle x 100ml

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

351/31.07.2012 154.5

761 CINARIZINE Tablets x 25mg CINNARIZINE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

645/10.12.2010 60

762 CINARIZINE Tablets x 25mg CINNARIZINE Box x 50

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

645/10.12.2010 100

763 CINARIZINE Tablets x 75mg CINNARIZINE Box x 50

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 140

764

CIPROFLOKSACI

NE

Solution for

infusion

(concentrate) x

100mg/10ml

CIPROFLOXACINE (as

CIPROFLOXACINE

LACTATE)

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 8000

765

CIPROFLOKSACI

NE

Solution for

infusion

(concentrate) x

100mg/10ml

CIPROFLOXACINE (as

CIPROFLOXACINE

LACTATE)

Box x 5

ampoules x

10ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 400

Page 105

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106

766 DEXA-NEO

Eye drops x (0.1%

+ 0.5%) - 5ml

DEXAMETHASONE

PHOSPHATE X 0.005G/5ML

(as DEXAMETHASONE

SODIUM PHOSPHATE X

0.0055G/5ML) + NEOMYCIN

SULPHATE X 0.025G/5ML

Box x 1 bottle x

5ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

339/03.06.2009 133.7

767 DEXA-NEO

Cream x (0.15% +

0.5%)/15g

DEXAMETHASONE

SODIUM PHOSPHATE +

NEOMYCIN SULPHATE

Box x 1 tube x

15g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

447/26.08.2009 166

768 DIAZEPAM

Solution for

injection x

10mg/2ml DIAZEPAM

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 1900

769 DURILAC

Tretësirë për

injeksion I.M. x

75mg/3ml DIKLOFENAK NATRIUMI

Kuti x 10

ampula

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

78/11.02.2010 250

770 DURILAC

Tretësirë për

injeksion I.M. x

75mg/3ml DIKLOFENAK NATRIUMI

Kuti x 100

ampula për

përdorim

spitalor

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

78/11.02.2010 2500

771 DURILAC Suposte x 100mg DIKLOFENAK NATRIUMI

Kuti x 10

suposte

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

78/11.02.2010 90

772 DURILAC Xhel x 1% DIKLOFENAK NATRIUMI

Kuti x 1 tubet x

30g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

78/11.02.2010 150

773 ECONAZOL Cream x 1% ECONAZOLE NITRATE

Box x 1 tube x

30g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 150

774 ENTEROSEPT

Tablets x (250mg +

25mg) CLIOQUINOL + CETRIMIDE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

190/27.04.2012 180

775 EUFILINE

Solution for

injection x 2.5%

(0.202g +

0.0505g)/10ml

THEOPHYLLINE +

ETHYLENEDIAMINE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

286/11.05.2009 450

776 EUFILINE

Solution for

injection x 2.5%

(0.202g +

0.0505g)/10ml

THEOPHYLLINE +

ETHYLENEDIAMINE

Box

x 100 ampoules

x 10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

286/11.05.2009 4500

Page 106

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107

777 EUFILINE 12%

Solution for

injection x (192mg

+ 48mg)/2ml

THEOPHYLLINE (as

ANHYDROUS) +

ETILENDIAMINE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 4500

778 EUGENOL

Drops solution x

100% EUGENOL

Box x 1 flacon x

5ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 80

779 FUROSEMID

Solution for

injection x

20mg/2ml FUROSEMIDE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 4000

780 GENTA Cream x 0.1%

GENTAMICIN x 0.015g/15g

(as GENTAMICIN

SULPHATE x 0.017g/15g)

Box x 1 tube x

15g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

447/26.08.2009 132

781 GENTAKOL

Eye drops solution

x 0.5% GENTAMICINE SULPHATE

Box x 1 flacon x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

339/03.06.2009 100

782 GENTAMYCINE

Solution for

injection x

40mg/2ml GENTAMYCINE SULPHATE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

265/12.06.2012 2000

783 GENTAMYCINE

Solution for

injection x

80mg/2ml GENTAMYCINE SULPHATE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

265/12.06.2012 2000

784

GLUKONAT

KALCIUMI

Solution for

injection x 1g/10ml CALCIUM GLUCONATE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 526

785

GLUKONAT

KALCIUMI

Solution for

injection x 1g/10ml CALCIUM GLUCONATE

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 5260

786 GLUKOZE

Solution for

injection x 4g/10ml GLUCOSE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 526

Page 107

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108

787 GLUKOZE

Solution for

injection x 4g/10ml GLUCOSE

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 5260

788 GLUKOZE 5%

Solution for

infusion x

50g/1000ml

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Glass bottle x

250ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

446/03.08.2010 100

789 GLUKOZE 5%

Solution for

infusion x

50g/1000ml

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Glass bottle x

500ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

446/03.08.2010 115

790 GLUKOZE

Solution for

infusion x

50g/1000ml

GLUCOSE ANHYDROUS

(as GLUCOSE

MONOHYDRATE x 55mg/ml)

Plastic bag x

250ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 100

791 GLUKOZE

Solution for

infusion x

50g/1000ml

GLUCOSE ANHYDROUS

(as GLUCOSE

MONOHYDRATE x 55mg/ml)

Plastic bag x

500ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 115

792 HALOPERIDOL

Solution for

injection x 5mg/ml HALOPERIDOL

Box x 10

ampoules x 1ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 450

793 HALOPERIDOL

Solution for

injection x 5mg/ml HALOPERIDOL

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 4500

794

HIPOSULFIT

NATRIUMI

Solution for

injection x 1g/10ml SODIUM THIOSULPHATE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 526

795

HIPOSULFIT

NATRIUMI

Solution for

injection x 1g/10ml SODIUM THIOSULPHATE

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 5260

Page 108

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109

796 IKTIOL Ointment x 10%

ICHTHAMMOL (AMMONIUM

SULPHO-ICHTHYOLATE)

Box x 1 tube x

20g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

333/29.08.2011 132

797 JODEX

Spray, solution x

8.5% (w/v) POVIDONE IODINE

Box x 1 flacon x

30ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

62/06.02.2013 190

798

KAFEINE

NATRIUM

BENZOAT

Solution for

injection x (96mg +

104mg)/ml

CAFFEINE (as

ANHYDROUS) + SODIUM

BENZOATE

Box x 10

ampoules x 1ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 450

799

KAFEINE

NATRIUM

BENZOAT

Solution for

injection x (96mg +

104mg)/ml

CAFFEINE (as

ANHYDROUS) + SODIUM

BENZOATE

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 4500

800

KALCIUM

GLUKONAT Tablets x 500mg CALCIUM GLUCONATE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 75

801 KARDIOSPIR

Enteric coated

tablets x 100mg ACETYLSALICYLIC ACID Box x 20

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

62/06.02.2013 70.2

802 ROFEN Gel x 2.5% KETOPROFEN

Box x tube x

50g

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

266/19.04.2013 250

803 KLORAMFENIKOL Tablets x 250mg CHLORAMPHENICOL Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 165

804 KLORAMFENIKOL

Oral suspension x

125mg/5ml

CHLORAMPHENICOL

PALMITATE

Box x 1 flacon x

60ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

333/29.08.2011 110

805 KLORAMFENIKOL

Ear drops, solution

x 5%-10ml CHLORAMPHENICOL

Box x 1 flakon x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

333/29.08.2011 95

806 KLORAMFENIKOL

Eye drops solution

x 0.5% (5mg/ml) CHLORAMPHENICOL

Box x 1 flacon x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 95

807 KLORPROMAZINE

Solution for

injection x

50mg/2ml

CHLORPROMAZINE

HYDROCHLORIDE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

808

KLORUR

KALCIUMI

Solution for

injection x 1g/10ml CALCIUM CHLORIDE

Box x 10

ampoules x 10m

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 526

Page 109

Page 110: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

110

809

KLORUR

KALCIUMI

Solution for

injection x 1g/10ml CALCIUM CHLORIDE

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 5260

810 KLORUR KALIUMI

Solution for

injection x

0.75g/10ml POTASSIUM CHLORIDE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 526

811 KLORUR KALIUMI

Solution for

injection x

0.75g/10ml POTASSIUM CHLORIDE

Box x 100

ampoules x 5ml

(for hospital

use)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 5260

812

KLORUR

NATRIUMI

Solution for

injection x 10% SODIUM CHLORIDE

Box x 10

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

339/03.06.2009 526

813

KLORUR

NATRIUMI

Solution for

injection x 10% SODIUM CHLORIDE

Box x 100

ampoules x

10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

339/03.06.2009 5260

814

KLORUR

NATRIUMI

Solution for

injection x

85mg/10ml SODIUM CHLORIDE

Box x 10

ampoules x 10m

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 526

815

KLORUR

NATRIUMI

Solution for

injection x

85mg/10ml SODIUM CHLORIDE

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 5260

816

KLORUR

NATRIUMI 0.9%

Solution for

infusion x

9g/1000ml SODIUM CHLORIDE

Plastic bag x

250ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 100

817

KLORUR

NATRIUMI 0.9%

Solution for

infusion x

9g/1000ml SODIUM CHLORIDE

Plastic bag x

500ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 115

818

KLORUR

NATRIUMI 0.9%

Solution for

infusion x

9g/1000ml SODIUM CHLORIDE

Glass bottle x

250ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

446/03.08.2010 100

819

KLORUR

NATRIUMI 0.9%

Solution for

infusion x

9g/1000ml SODIUM CHLORIDE

Glass bottle x

500ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

446/03.08.2010 115

820 KORONARINE

Coated tablets x

25mg DIPYRIDAMOLE Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

76/01.03.2011 156

Page 110

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111

821 LANATOZID C

Solution for

injection x

0.4mg/2ml LANATOSIDE C

Box x 10

ampoules x 2ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 490

822 LANATOZID C

Solution for

injection x

0.4mg/2ml LANATOSIDE C

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4900

823 LIDOKAINE

Solution for

injection x 2%

(20mg/ml)

LIDOCAINE

HYDROCHLORIDE

Box x flacon x

50ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

598/26.11.2012 125

824

LIDOKAINE ME

ADRENALINE

Solution for

injection x (1g +

0.5mg)/vial - 50ml

LIDOCAINE

HYDROCHLORIDE +

EPINEPHRINE (as

EPINEPHRINE

BITARTRATE)

Box x 1 glass

vial x 50ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

235/07.06.2011 125

825

PRODLIDOKAINE/

ADRENALINE

Solution for

injection x (40mg +

0.02mg)/2ml

LIDOCAINE HCl +

EPINEPHRINE (AS

EPINEPHRINE

BITARTRATE 0.036MG)

Box x 10

ampoules x 2ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

109/01.03.2013 300

826 LOPERAMID Tablets x 2mg

LOPERAMIDE

HYDROCHLORIDE Box x 20

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 136

827 LUMINAL

Solution for

injection x 10% -

2ml

PHENOBARBITAL (as

PHENOBARBITAL SODIUM

x 0.22g/2ml)

Box x 10

ampoules x 2ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

289/06.05.2010 450

828 LUMINAL

Solution for

injection x 10% -

2ml

PHENOBARBITAL (as

PHENOBARBITAL SODIUM

x 0.22g/2ml)

Box x 100

ampoules x 2ml

(for hospital

use)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

289/06.05.2010 4500

829

LOCION

MALATION

Solution x

0.5g/100ml MALATHION Flacon x 100ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

348/05.06.2009 130

830 MANITOL

Solution for

infusion x

200mg/ml MANNITOL

Glass bottle x

250ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 220

831 MANITOL

Solution for

infusion x

200g/1000ml MANNITOL

Plastic bag x

250ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 220

832 MANITOL

Solution for

infusion x

200g/1000ml MANNITOL

Plastic bag x

500ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 380

Page 111

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112

833 MEBHIDROLINE

Coated tablets x

50mg

MEBHYDROLINE

NAPADISYLATE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

75/01.03.2011 264

834 METRONIDAZOL

Solution for

infusion x 0.5%

(0.5g/100ml) METRONIDAZOLE Flacon x 100ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 200

835

METRONIDAZOL

0.5%

Solution for

infusion x

5g/1000ml METRONIDAZOL

Plastic bag x

100ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ

186/26.04.2012 200

836 MIKONAL

Ovula vaginale x

100mg NITRAT MIKONAZOLI Kuti x 10

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

148/09.03.2010 200

837 MUKOLITINE A Syrup x 5%

CARBOCISTEINE X

250MG/5ML

Box x 1 glass

bottle x 150ml

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

351/31.07.2012 160

838 MUKOLITINE P Syrup x 2%

CARBOCISTEINE X

100MG/5ML

Box x 1 glass

bottle x 150ml

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

351/31.07.2012 150

839

NAFAZOLINE

0.1%

Nasal drops,

solution x 1mg/ml NAPHAZOLINE NITRATE

Box x 1 plastic

bottle x 10ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 120

840 NAFAZOLINE

Nasal spray,

solution x 1 mg / ml NAPHAZOLINE NITRATE

Box x 1 plastic

bottle x 10 ml

"PROFARMA SH.A" -

SHQIPERI

"PROFARMA SH.A"

SHQIPERI

RIREGJ

372/27.09.2011 120

841 NEOBAC

Ointment x (5mg +

500I.U.)/1g

NEOMYCIN SULPHATE +

BACITRACIN

Box x 1 tube x

30g

PROFARMA SH.A. -

SHQIPERI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

358/10.06.2009 280

842 NEURO B

Solution for

injection x (100mg

+ 50mg +

0.5mg)/2ml

VITAMIN B1 + VITAMIN B6 +

VITAMIN B12

Box x 10

ampoules x 2ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

71/09.02.2010 350

843 NISTATINE

Oral suspension x

100 000 IU/ml NYSTATIN

Box x 1 glass

bottle x 30ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

43/28.01.2009 150

844 OTOL

Ear drops, solution

x (30mg + 20mg +

50mg)/ml

PROCAINE

HYDROCHLORIDE +

PHENOL + PHENAZONE

Box x 1 plastic

bottle x 5ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 100

Page 112

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113

845 PAPAVERINE

Solution for

injection x 40mg/ml

PAPAVERINE

HYDROCHLORIDE

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

846 PARACETAMOL Tablets x 500mg PARACETAMOL Box x 20

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 38.2

847 PARACETAMOL Tablets x 500mg PARACETAMOL Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

433/2/ 28.09.2012 111.6

848 PARACETAMOL Syrup x 120mg/5ml PARACETAMOL

Box x 1 glass

bottle x 100ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

47/30.01.2012 250

849 PARACETAMOL

Suppositories x

100mg PARACETAMOL Box x 10

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

62/06.02.2013 70

850 PERTUSINE

Syrup x (120mg +

10mg)/g

THYMI EXTRACT +

POTASSIUM BROMIDE

Box x 1 glass

bottle x 100g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 119

851 PETIDINE

Solution for

injection x

100mg/2ml

PETHIDINE

HYDROCHLORIDE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

260/12.06.2012 13000

852 PIPERAZINE Tablets x 250mg PIPERAZINE ADIPATE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

647/10.12.2010 135

853 BETADYNE

Solution x

100mg/ml POVIDONE IODINE

Box x 1 plastic

bottle x 100ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 154.5

854 BETADYNE

Solution x

100mg/ml POVIDONE IODINE

Plastic bottle x

1000ml (for

hospital use

only)

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 750

855 POVIDON JOD Ovules x 200mg POVIDONE IODINE Box x 14 PROFARMA - SHQIPERI PROFARMA - SHQIPERI

RIREGJ.

43/28.01.2009 161

856

PREDNIZOLON

0.5%

Ointment x

0.005g/g PREDNISOLONE ACETATE

Box x 1 tube x

5g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 100

857 PRODBENZOATE

Emulsion x 25%

(w/v) BENZYL BENZOATE

Box x 1 plastic

bottle x 200ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

105/06.03.2012 130

Page 113

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114

858 PRODIVAKAINE 5

Solution for

injection x 5mg/1ml

BUPIVACAINE

HYDROCHLORIDE

Box x 1 glass

vial x 20ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

75/17.02.2012 300

859 PRODRENITIDI

Solution for

injection x

50mg/5ml

RANITIDINE

HYDROCHLORIDE

Box x 10

ampoules x 5ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

266/19.04.2013 450

860 PRODRENITIDI

Solution for

injection x

50mg/5ml

RANITIDINE

HYDROCHLORIDE

Box x 100

ampoules x 5ml

(for hospital

use)

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

266/19.04.2013 4500

861 PROGESTERON

Solution for

injection x 25mg/ml PROGESTERONE

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 4000

862 PROMETAZINE

Solution for

injection x

50mg/2ml

PROMETHAZINE

HYDROCHLORIDE

Box x 10

ampoules x 2ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 450

863 PROMETAZINE

Solution for

injection x

50mg/2ml

PROMETHAZINE

HYDROCHLORIDE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

864 PROSERINE

Solution for

injection x

0.5mg/ml NEOSTIGMINE BROMIDE

Box x 10

ampoules x 1ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 450

865 PROSERINE

Solution for

injection x

0.5mg/ml NEOSTIGMINE BROMIDE

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

207/20.05.2011 4500

866 PRO-SYNAL

Rectal cream x

(0.1mg + 20mg)/g

FLUOCINOLONE

ACETONIDE + LIDOCAINE

HYDROCHLORIDE

Box x 1 tube x

15g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

286/11.05.2009 130

867 RINGER LACTATE

Solution for

infusion x (0.135g

+ 0.2g + 3g +

1.56g)/500ml

CALCIUM CHLORIDE

DIHYDRATE + POTASSIUM

CHLORIDE + SODIUM

CHLORIDE + SODIUM

LACTATE Flacon x 500ml

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

351/31.07.2012 130

Page 114

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115

868 SILDENAFIL

Film-coated tablets

x 50mg

SILDENAFIL (as

SILDENAFIL CITRATE x

70.24mg) Box x 4

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

664/21.12.2010 800

869

SOLUCION

FIZIOLOGJIK

Nasal drops

solution x 0.9% SODIUM CHLORIDE

Box x 1 flacon x

10ml

PRODENTALFARMA -

SHQIPERI

PRODENTALFARMA -

SHQIPERI

RIREGJ.

392/01.07.2009 57

870 SPARTEINE

Solution for

injection x 50mg/ml

SPARTEINE (as

SULPHATE)

Box x 10

ampoules x 1ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 450

871 SPARTEINE

Solution for

injection x 50mg/ml

SPARTEINE (as

SULPHATE)

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 4500

872 SPAZMOFARMA Tablets x 5mg OXYPHENONIUM BROMIDE Box x 30

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 261

873 STOMAKURAN Suspension x 40% SULFANILAMIDE

Box x 1 glass

bottle x 15g

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ.

43/28.01.2009 300

874 SULFAT MAGNEZI

Solution for

injection x

2.5g/10ml

MAGNESIUM SULPHATE

HEPTAHYDRATE

Box x 100

ampoules x

10ml (for

hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 4900

875 TETRA Eye ointment x 1%

TETRACYCLINE

HYDROCHLORIDE

Box x 1 tube x

5g

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ

409/07.10.2011 136

876 TETRACIKLINE Ointment x 3 %

TETRACYCLINE

HYDROCHLORIDE

Box x 1 tube x

15g

PROFARMA SH.A. -

SHQIPERI

PROFARMA SH.A. -

SHQIPERI

RIREGJ

458/19.08.2013 136

877

UJE I

OKSIGJENUAR Solution x 30mg/ml HYDROGEN PEROXIDE Flacon x 100ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 65

878

UJE PER

INJEKSION

Water for injection

x 2ml, 5ml, 10ml WATER FOR INJECTION Box x 100 x 2ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 2000

879

UJE PER

INJEKSION

Water for injection

x 2ml, 5ml, 10ml WATER FOR INJECTION Box x 100 x 5ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 2500

880

UJE PER

INJEKSION

Water for injection

x 2ml, 5ml, 10ml WATER FOR INJECTION

Box x 100 x

10ml

PROFARMA SHA -

SHQIPERI PROFARMA SHA - SHQIPERI

RIREGJ

334/20.05.2013 2800

Page 115

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116

881 VITAMINE B12

Solution for

injection x

100µg/ml CYANOCOBALAMIN

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

882

VITAMINE B

KOMPLEKS

Coated tablets x

(5mg + 2mg + 2mg

+ 30mg)

THIAMINE

HYDROCHLORIDE +

PIRIDOXINE

HYDROCHLORIDE +

RIBOFLAVIN +

NICOTINAMIDE Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

75/01.03.2011 187.2

883 VITAMINE B1 Tablets x 10mg

THIAMINE

HYDROCHLORIDE Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 105

884 VITAMINE B1

Solution for

injection x 50mg/ml

THIAMINE

HYDROCHLORIDE

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

885 VITAMINE B6 Tablets x 25mg

PYRIDOXINE

HYDROCHLORIDE Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

676/31.12.2010 105

886 VITAMINE B6

Solution for

injection x

100mg/2ml

PYRIDOXINE

HYDROCHLORIDE

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

887 VITAMINE C Tablets x 100mg ASCORBIC ACID Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

645/10.12.2010 118.8

888 VITAMINE C

Solution for

injection x

100mg/2ml ASCORBIC ACID

Box x 100

ampoules x 2ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

190/12.05.2011 4500

889 VITAMINE D2

Solution for IM

injection x 300 000

UI/ml ERGOCALCIFEROL

Box x 10

ampoules x 1ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 400

890 VITAMINE D2

Solution for IM

injection x 300 000

UI/ml ERGOCALCIFEROL

Box x 100

ampoules x 1ml

(for hospital use

only)

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

168/04.05.2011 4000

Page 116

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117

891 VITAMINE E

Coated tablets x

10mg

ALFA-TOCOPHEROL

ACETATE Box x 60

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

RIREGJ.

75/01.03.2011 180

892 GONAL - F

Powder and

solvent for solution

for injection x 75

IU/vial (5.5µg/vial) FOLLITROPIN ALFA

Box x 1 glass

vial of powder +

1 pre-filled

syringe of

solvent x 1ml

MERCK SERONO

EUROPE LTD -

MBRETERI E BASHKUAR

MERCK SERONO S.A. -

ZVICER; MERCK SERONO

S.P.A. - ITALI

RIREGJ

46/30.01.2012 22

893

GLUCOVANCE

500MG/2.5MG

Film coated tablets

x (500mg + 2.5mg)

METFORMIN x 390mg (in

the form of METFORMIN

HYDROCHLORIDE x

500mg) + GLIBENCLAMIDE Box x 30

MERCK SANTE SAS -

FRANCE

MERCK SANTE SAS (centre

de production SEMOY) -

FRANCE [APL: MERCK

SANTE SAS (centre de

production SEMOY) -

FRANCE]

RIREGJ.

71/09.02.2010 2.43

894

GLUCOVANCE

500MG/5MG

Film coated tablets

x (500mg + 5mg)

METFORMIN x 390mg (in

the form of METFORMIN

HYDROCHLORIDE x

500mg) + GLIBENCLAMIDE Box x 30

MERCK SANTE SAS -

FRANCE

MERCK SANTE SAS (centre

de production SEMOY) -

FRANCE [APL: MERCK

SANTE SAS (centre de

production SEMOY) -

FRANCE]

RIREGJ.

71/09.02.2010 2.67

895 PRAXILENE

Film coated tablets

x 200mg

NAFTIDROFURYL

HYDROGEN OXALATE Box x 20

MERCK LIPHA SANTE -

FRANCE

FAMAR LYON - FRANCE,

MERCK SL - SPANJE

RIREGJ.

447/26.08.2009 3.95

896 NALOREX

Film coated tablets

x 50mg

NALTREXONE

HYDROCHLORIDE Box x 14

L. MOLTENI & C. DEI

F.LLI ALITTI SOCIETA DI

ESERCIZIO SPA - ITALI

ISTITUTO DE ANGELI S.R.L. -

ITALI

REGJ.

284/11.05.2009 28

897 ABDUCE Cream x 5% w/w ACYCLOVIR

Box x tube x

10g IASIS PHARMA - GREQI IASIS PHARMA - GREQI

REGJ.

369/17.06.2009 3.38

898 ABDUCE Cream x 5% w/w ACYCLOVIR Box x tube x 5g IASIS PHARMA - GREQI IASIS PHARMA - GREQI

REGJ.

369/17.06.2009 2.84

899 ARFAREL

Solution for

external use x 1%

w/v

CLINDAMYCIN (as

CLINDAMYCIN

PHOSPHATE)

Box x flacon x

30ml IASIS PHARMA - GREQI IASIS PHARMA - GREQI

REGJ.

369/17.06.2009 2.18

900 FLUSTERIX

Cream x 2% w/w

(20mg/g) FUSIDIC ACID

Box x 1 tube x

15g IASIS PHARMA - GREQI IASIS PHARMA - GREQI

REGJ.

369/17.06.2009 1.7

901 MOVESAN Cream x 1mg/g MOMETASONE FUROATE

Box x 1 tube x

25g IASIS PHARMA - GREQI IASIS PHARMA - GREQI

RIREGJ

597/26.11.2012 4.8

Page 117

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118

902 ENIDAP Capsules x 50mg

SERTRALINE

HYDROCHLORIDE x

55.95MG

CORRESPONDING TO

SERTRALINE x 50MG Box x 30 IASIS PHARMA - GREQI

FAMAR SA, L'AIGLE -

FRANCE; IASIS PHARMA -

GREQI

REGJ.

396/07.07.2009 9.51

903 ENIDAP Capsules x 100mg

SERTRALINE

HYDROCHLORIDE x

111.9MG

CORRESPONDING TO

SERTRALINE x 100MG Box x 30 IASIS PHARMA - GREQI

FAMAR SA, L'AIGLE -

FRANCE; IASIS PHARMA -

GREQI

REGJ.

396/07.07.2009 12.13

904

ENIDAP Capsules x 50mg

SERTRALINE

HYDROCHLORIDE x

55.95MG

CORRESPONDING TO

SERTRALINE x 50MG

Box x 14

FARMANIC-

CHEMIPHARMA SA -

GREQI

FAMAR SA, L'AIGLE -

FRANCE; FAMAR SA (PLANT

B') - GREQI

REGJ.

396/07.07.2009

6.28

905

ENIDAP Capsules x 100mg

SERTRALINE

HYDROCHLORIDE x

111.9MG

CORRESPONDING TO

SERTRALINE x 100MG

Box x 14

FARMANIC-

CHEMIPHARMA SA -

GREQI

FAMAR SA, L'AIGLE -

FRANCE; FAMAR SA (PLANT

B') - GREQI

REGJ.

396/07.07.2009

9.3

906 ANESIA 10MG/ML

Emulsion for

injection/infusion x

200mg/20ml PROPOFOL

Box x 5 vials x

20ml

UAB NORAMEDA -

LITUANI

SVIZERA EUROPE BV -

HOLLANDE (APL: ALLEMAN

PHARMA GMBH - GJERMANI

REGJ

307/07.05.2013 17.5

907

PANCURONIUM

INRESA

Solution for

injection x 4mg/2mlPANCURONIUM BROMIDE

Box x 10

ampoules

"INRESA ARZNEIMITTEL

GMBH" GJERMANI

"ROTEXMEDICA GMBH"

GJERMANIRegj.475/09.09.2013

11.4

908 PINTAL Syrup x 7.5mg/5ml BUTAMIRATE CITRATE

Box x 1 glass

bottle x 200ml

ALET

PHARMACEUTICALS S.A.

- GREQI SPECIFAR SA - GREQI

RIREGJ.

602/05.11.2010 3.6

909 SPECILID Tablets x 100mg NIMESULIDE Box x 30

ALET

PHARMACEUTICALS S.A.

- GREQI SPECIFAR SA - GREQI

RIREGJ.

602/05.11.2010 3.5

910 ABROLEN Syrup x 30mg/5ml

ABROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 125ml

ALET

PHARMACEUTICALS SA -

GREQI SPECIFAR SA - GREQI

RIREGJ

471/11.11.2011 2.5

911 AZITHRIN

Film Coated

Tablets x 500 mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524 mg) Box x 3

ALET

PHARMACEUTICALS SA -

GREQI KERN PHARMA SA - SPANJE

REGJ.

191/19.03.2009 5.62

Page 118

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119

912 BICATIN

Film-coated tablets

x 50mg BICALUTAMIDE Box x 28

PHARMANEL

PHARMACEUTICALS SA -

GREQI

KOCAK FARMA ILAC VE

KIMYA SANAYI AS - TURQI

REGJ.

156/20.04.2011 50

913 OSTEOVILE

Soft capsules x

1mcg ALFACALCIDOL

Box x 100 (for

hospital use)

PHARMANEL

PHARMACEUTICALS SA -

GREQI

ONE PHARMA INDUSTRIAL

PHARMACEUTICAL

COMPANY S.A - GREQI;

SWISS CAPS AG - ZVICER

REGJ.

156/20.04.2011 15

914 DIFONATE Tablets x 70mg

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE x 91.37mg) Box x 4

PHARMANEL

PHARMACEUTICALS SA -

GREQI

ONE PHARMA INDUSTRIAL

PHARMACEUTICAL

COMPANY S.A - GREQI

REGJ

334/29.08.2011 15

915 RECOSINE

Powder for oral

solution x

1500mg/sachet

GLUCOSAMINE SULFATE

(as GLUCOSAMINE

SULFATE SODIUM SALT x

1884mg/sachet)

Box x 30

sachets

PHARMANEL

PHARMACEUTICALS SA -

GREQI

ONE PHARMA INDUSTRIAL

PHARMACEUTICAL

COMPANY S.A - GREQI

REGJ

334/29.08.2011 10.5

916 DOCETAX-20

Concentrate for

solution for infusion

x 20mg/0.5ml

DOCETAXEL ANHYDROUS

(as DOCETAXEL

TRIHYDRATE)

Box x 1 single-

dose glass vial -

0.5ml of

concentrate +

Box x 1 single-

dose glass vial -

1.5ml of solvent

M/S CIPLA LTD - INDI (e

regjistruar ne Bullgari) M/S CIPLA LTD - INDI

REGJ.

311/17.05.2010 60

917 DOCETAX-80

Concentrate for

solution for infusion

x 80mg/2ml

DOCETAXEL ANHYDROUS

(as DOCETAXEL

TRIHYDRATE)

Box x 1 single-

dose glass vial -

2ml of

concentrate +

Box x 1 single-

dose glass vial -

6ml of solvent

M/S CIPLA LTD - INDI (e

regjistruar ne Bullgari) M/S CIPLA LTD - INDI

REGJ.

311/17.05.2010 150

Page 119

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120

918 ETOSID

Solution for

injection x

100mg/5ml ETOPOSIDE

Box x 1 vial x

5ml

CIPLA LTD - INDI (e

regjistruar ne Bullgari) CIPLA LTD - INDI

RIREGJ.

532/14.10.2009 6

919

IRINOTECAN

HYDROCHLORIDE

Concentrate for

solution for infusion

x 40mg/2ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE

Box x 1 vial x

2ml

M/S CIPLA LTD - INDI (e

regjistruar ne Bullgari) M/S CIPLA LTD - INDI

REGJ.

311/17.05.2010 35

920

IRINOTECAN

HYDROCHLORIDE

Concentrate for

solution for infusion

x 100mg/5ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE

Box x 1 vial x

5ml

M/S CIPLA LTD - INDI (e

regjistruar ne Bullgari) M/S CIPLA LTD - INDI

REGJ.

311/17.05.2010 70

921

CYTOBLASTIN

AQUEOUS

Solution for

injection x 1mg/ml VINBLASTINE SULPHATE

Box x 1 vial x

10ml

CIPLA LTD - INDI (e

regjistruar ne Bullgari) CIPLA LTD - INDI

RIREGJ.

532/14.10.2009 10

922

CYTOCRISTIN

AQUEOUS

Solution for

injection x 1mg/ml VINCRISTINE SULPHATE

Box x 1 vial x

1ml

CIPLA LTD - INDI (e

regjistruar ne Bullgari) CIPLA LTD - INDI

RIREGJ.

532/14.10.2009 7

923 SEROR

Film Coated

Tablets x 20 mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x 24.980

mg) Box x 28 SPECIFAR SA - GREQI

ATLANTIC PHARMA -

PRODUCOES

FARMACEUTICAS S.A. -

PORTUGALI

REGJ.

191/19.03.2009 10

924 SEROR

Film Coated

Tablets x 40 mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x 49.960

mg) Box x 28 SPECIFAR SA - GREQI

ATLANTIC PHARMA -

PRODUCOES

FARMACEUTICAS S.A. -

PORTUGALI

REGJ.

191/19.03.2009 21

925 NEO-SEPTOL

Hard-capsules x

2mg

LOPERAMIDE

HYDROCHLORIDE Box x 18 SPECIFAR SA - GREQI SPECIFAR SA - GREQI

RIREGJ.

583/29.10.2010 2

926 LOSARB PLUS

Film-coated tablets

x (50 + 12.5)mg

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDE Box x 30 SPECIFAR SA - GREQI SPECIFAR SA - GREQI

REGJ.

156/20.04.2011 12

927 LOSARB PLUS

Film-coated tablets

x (100 + 25)mg

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDE Box x 30 SPECIFAR SA - GREQI SPECIFAR SA - GREQI

REGJ.

156/20.04.2011 16.76

928 PONSTAN

Film- coated

tablets x 500mg MEFENAMIC ACID Box x 15

"PFIZER HELLAS AE' -

GREQI

"FAMAR ABE, ANTHOUSA

PLANT" - GREQI

RIREGJ

366/23.09.2011 1.35

Page 120

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121

929 PONSTAN

Oral suspension x

50mg/5ml MEFENAMIC ACID

Box x 1 glass

bottle x 125ml

"PFIZER HELLAS AE' -

GREQI "FAMAR ABE" - GREQI

RIREGJ

366/23.09.2011 1.35

930 XANAX Tablets x 0.25mg ALPRAZOLAM Box x 30 PFIZER SA - BELGJIKE

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE;

SANICO NV - BELGJIKE;

PFIZER PHARMACEUTICALS

LLC - PORTO RIKO; PFIZER

ITALIA SRL - ITALI (APL:

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE)

RIREGJ.

78/11.02.2010 1.4

931 XANAX Tablets x 0.5mg ALPRAZOLAM Box x 30 PFIZER SA - BELGJIKE

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE;

SANICO NV - BELGJIKE;

PFIZER PHARMACEUTICALS

LLC - PORTO RIKO; PFIZER

ITALIA SRL - ITALI (APL:

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE)

RIREGJ.

78/11.02.2010 1.9

932 SORTIS

Film coated tablets

x 40mg

ATORVASTATIN ( AS

ATORVASTATIN-

HEMICALCIUM 1.5 H2O x

43.38mg) Box x 30

PARKE-DAVIS GMBH -

GJERMANI

PFIZER IRELAND

PHARMACEUTICALS -

IRLANDE, PFIZER

MANUFACTURING

DEUTSCHLAND GMBH -

GJERMANI

REGJ.

192/19.03.2009 12

933 SORTIS

Film coated tablets

x 80mg

ATORVASTATIN ( AS

ATORVASTATIN-

HEMICALCIUM 1.5 H2O x

86.76mg) Box x 30

PARKE-DAVIS GMBH -

GJERMANI

PFIZER IRELAND

PHARMACEUTICALS -

IRLANDE, PFIZER

MANUFACTURING

DEUTSCHLAND GMBH -

GJERMANI

REGJ.

192/19.03.2009 25.61

Page 121

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122

934 CELEBREX

Hard capsules x

200mg CELECOXIB Box x 10

PHARMACIA LIMITED -

MBRETERI E BASHKUAR

PHARMACIA LIMITED -

MBRETERI E BASHKUAR;

PFIZER PHARMACEUTICALS

LLC - PORTO RIKO; PFIZER

MANUFACTURING

DEUTSCHLAND GMBH -

GJERMANI; PFIZER

PHARMACEUTICALS LLC

(VEGA BAJA) - PORTO RIKO

REGJ.

534/15.10.2009 5.5

935 CELEBREX

Hard capsules x

200mg CELECOXIB Box x 30

PHARMACIA LIMITED -

MBRETERI E BASHKUAR

PHARMACIA LIMITED -

MBRETERI E BASHKUAR;

PFIZER PHARMACEUTICALS

LLC - PORTO RIKO; PFIZER

MANUFACTURING

DEUTSCHLAND GMBH -

GJERMANI; PFIZER

PHARMACEUTICALS LLC

(VEGA BAJA) - PORTO RIKO

REGJ.

534/15.10.2009 11

936 DALACIN C Capsules x 150mg

CLINDAMYCIN (as

CLINDAMYCIN

HYDROCHLORIDE x

177.515mg) Box x 16

PFIZER HOLDING

FRANCE - FRANCE

PFIZER PGM - FRANCE

(APL: PFIZER PGM -

FRANCE)

RIREGJ.

344/03.06.2010 2

937 DALACIN C Capsules x 300mg

CLINDAMYCIN (as

CLINDAMYCIN

HYDROCHLORIDE x

355.03mg) Box x 16

PFIZER HOLDING

FRANCE - FRANCE

PFIZER PGM - FRANCE

(APL: PFIZER PGM -

FRANCE)

RIREGJ.

344/03.06.2010 3.8

938 DALACIN C

Solution for

injection x

150mg/ml

CLINDAMYCIN (as

CLINDAMYCIN-2-

PHOSPHATE )

Box x 1

ampoule x 2ml PFIZER SA - BELGJIKE

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKË

(APLIKANT: PFIZER

MANUFACTURING BELGIUM

NV - BELGJIKË)

RIREGJ.

531/14.10.2009 1.2

Page 122

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123

939 DALACIN C Topical lotion x 1%

CLINDAMYCIN

PHOSPHATE

Box x bottle x

60ml

PHARMACIA & UPJOHN

COMPANY - SHBA

PHARMACIA & UPJOHN

COMPANY - SHBA (APL:

PFIZER INC - SHBA)

RIREGJ.

632/19.11.2009 6.64

940 DALACIN C

Topical solution x

1%

CLINDAMYCIN

PHOSPHATE

Box x bottle x

30ml

PHARMACIA & UPJOHN

COMPANY - SHBA

PHARMACIA & UPJOHN

COMPANY - SHBA (APL:

PFIZER INC - SHBA)

RIREGJ.

632/19.11.2009 2.8

941

FRAGMIN

Solution for

injection x 10000IU

(anti-Xa)/ml

DALTEPARIN NATRICUM

Box x 10 pre-

filled syringes x

1ml

PFIZER SA - BELGJIKE

VETTER PHARMA-

FERTIGUNG GMBH&CO.KG

(SCHUTZENSTRASSE 87) -

GJERMANI; VETTER

PHARMA-FERTIGUNG

GMBH&CO.KG -

(MOSWIESEN 2) GJERMANI;

PFIZER MANUFACTURING

BELGIUM N.V. - BELGJIKE

(APLIKANT PER

CERTIFIKATE: PFIZER

MANUFACTURING BELGIUM

N.V. - BELGJIKE

RIREGJ.

633/20.11.2013

52.57

Page 123

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124

942

FRAGMIN

Solution for

injection x 2500IU

(anti-Xa)/0.2ml

DALTEPARIN NATRICUM

Box x 10 pre-

filled syringes x

0.2ml

PFIZER SA - BELGJIKE

CATALENT FRANCE

LIMOGES SAS - FRANCE;

VETTER PHARMA-

FERTIGUNG GMBH&CO.KG

(SCHUTZENSTRASSE 87) -

GJERMANI; VETTER

PHARMA-FERTIGUNG

GMBH&CO.KG -

(MOSWIESEN 2) GJERMANI;

PFIZER MANUFACTURING

BELGIUM N.V. - BELGJIKE

(APLIKANT PER

CERTIFIKATE: PFIZER

MANUFACTURING BELGIUM

N.V. - BELGJIKE

RIREGJ.

633/20.11.2013

16.14

943

FRAGMIN

Solution for

injection x 5000IU

(ANTI - Xa)/0.2ml

DALTEPARIN NATRICUM

Box x 10 pre-

filled syringes x

0.2ml

PFIZER SA - BELGJIKE

CATALENT FRANCE LIMGES

SAS - FRANCE; VETTER

PHARMA - FERTIGUNG

GMBH & CO.KG -

(SCHUTZENSTRASSE 87)

GJERMANI; VETTER

PHARMA - FERTIGUNG

GMBH & CO.KG -

(MOSWEISEN 2) GJERMANI;

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE

(APLIKANT PER

CERTIFIKATE: PFIZER

MANUFACTURING BELGIUM

NV - BELGJIKE)

RIREGJ.

50/04.02.2013

29.8

Page 124

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125

944

DIFLUCANSolucion for

infusion x 2mg/mlFLUCONAZOLE

Box x 1 glass

bottle x 100ml

PFIZER HOLDING

FRANCE - FRANCE

PFIZER PGM - FRANCE dhe

me aplikant per çertifikate

PFIZER PGM - FRANCE

RIREGJ.

633/20.11.2013

8.12

945

DIFLUCAN Capsules x 50mg FLUCONAZOLE Box x 7PFIZER HOLDING

FRANCE - FRANCE

PFIZER PGM - FRANCE dhe

me aplikant per çertifikate

PFIZER PGM - FRANCE

RIREGJ.

633/20.11.2013

5.96

946 CAMPTO CS

Concentrate for

solution for infusion

x 20mg/ml

IRINOTECAN

HYDROCHLORIDE

Box x 1 vial x

5ml

PFIZER AUSTRALIA PTY

LTD - AUSTRALI

PFIZER (PERTH) PTY

LIMITED - AUSTRALI

REGJ.

567/27.10.2009 70

947

MEDROL Tablets x 4mg METHYLPREDNISOLONE Box x 30"PFIZER ITALIA S.R.L."

ITALI

PFIZER ITALIA SRL - ITALI,

PHARMACIA LIMITED -

MBRETERI E BASHKUAR

RIREGJ.

531/14.10.2009 ;

VARIACION 426/1

dt.01.11.2012 2

948

MEDROL Tablets x 16mg METHYLPREDNISOLONE Box x 20"PFIZER ITALIA S.R.L."

ITALI

PFIZER ITALIA SRL - ITALI,

PHARMACIA LIMITED -

MBRETERI E BASHKUAR

RIREGJ.

531/14.10.2009 ;

VARIACION 426/1

dt.01.11.2012 3.8

949 ZOLOFT

Film-coated tablets

x 50mg

SERTALINE (as SERTALINE

HYDROCHLORIDE x

55.95mg) Box x 30

PFIZER ITALIA SRL -

ITALI

HAUPT PHARMA LATINA

SRL - ITALI

RIREGJ

47/30.01.2012 4.5

950 VIAGRA

Film coated tablets

x 50mg

SILDENAFIL AS

SILDENAFIL CITRATE Box x 4

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER PMG - FRANCE

RIREGJ

333/29.08.2011 22.2

951 VIAGRA

Film coated tablets

x 50mg

SILDENAFIL AS

SILDENAFIL CITRATE Box x 2

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER PMG - FRANCE

RIREGJ

333/29.08.2011 11.1

952 VIAGRA

Film coated tablets

x 100mg

SILDENAFIL AS

SILDENAFIL CITRATE Box x 4

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER PMG - FRANCE

RIREGJ

333/29.08.2011 25.04

953 VIAGRA

Film coated tablets

x 100mg

SILDENAFIL AS

SILDENAFIL CITRATE Box x 2

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER PMG - FRANCE

RIREGJ

333/29.08.2011 12.52

954 SUTENT

Hard capsules x

12.5mg

SUNITINIB (as SUNITINIB

MALATE) Box x 1 vial x 30

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER ITALIA SRL - ITALI

REGJ.

571/27.10.2009 1316.9

Page 125

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126

955 SUTENT

Hard capsules x

12.5mg

SUNITINIB (as SUNITINIB

MALATE)

Box x 28 [4x

(blister x 7)]

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER ITALIA SRL - ITALI

REGJ.

571/27.10.2009 1229.2

956 SUTENT

Hard capsules x

25mg

SUNITINIB (as SUNITINIB

MALATE) Box x 1 vial x 30

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER ITALIA SRL - ITALI

REGJ.

571/27.10.2009 2377.3

957 SUTENT

Hard capsules x

25mg

SUNITINIB (as SUNITINIB

MALATE)

Box x 28 [4x

(blister x 7)]

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER ITALIA SRL - ITALI

REGJ.

571/27.10.2009 2218.7

958 SUTENT

Hard capsules x

50mg

SUNITINIB (as SUNITINIB

MALATE) Box x 1 vial x 30

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER ITALIA SRL - ITALI

REGJ.

571/27.10.2009 4754.5

959 SUTENT

Hard capsules x

50mg

SUNITINIB (as SUNITINIB

MALATE)

Box x 28 [4x

(blister x 7)]

PFIZER LTD - MBRETERI

E BASHKUAR PFIZER ITALIA SRL - ITALI

REGJ.

571/27.10.2009 4437.4

960 AROMASIN

Coated tablets x

25mg EXEMESTANE Box x 30

PHARMACIA LIMITED -

MBRETERI E BASHKUAR

PHARMACIA LIMITED -

MBRETERI E BASHKUAR;

PFIZER ITALIA SRL - ITALI

REGJ.

588/29.10.2010 30

961 ZITROMAX

Film-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.11mg) Box x 3

PFIZER ITALIA SRL -

ITALI

HAUPT PHARMA LATINA

SRL - ITALI

REGJ

297/25.06.2012 5.31

962 CADUET

Film-coated tablets

x (5mg + 10mg)

AMLODIPINE (as

AMLODIPINE BESILATE) +

ATORVASTATIN (as

ATORVASTATIN CALCIUM

TRIHYDRATE) Box x 30

PFIZER HOLDING

FRANCE - FRANCE

PFIZER GMBH

ARZNEIMITTELWERK

GODECKE - GJERMANI

REGJ

297/25.06.2012 10

963 CADUET

Film-coated tablets

x (10mg + 10mg)

AMLODIPINE (as

AMLODIPINE BESILATE) +

ATORVASTATIN (as

ATORVASTATIN CALCIUM

TRIHYDRATE) Box x 30

PFIZER HOLDING

FRANCE - FRANCE

PFIZER GMBH

ARZNEIMITTELWERK

GODECKE - GJERMANI

REGJ

297/25.06.2012 11.33

Page 126

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127

964 ENBREL

Solution for

injection x

25mg/pre-filled

syringe ETANERCEPT

Box x (4 pre-

filled syringes

and 8 alcohol

swabs)

WYETH EUROPA LTD -

MBRETERI E BASHKUAR

WYETH MEDICA IRELAND -

IRLANDE; BOEHRINGER

INGELHEIM PHARMA KG -

GJERMANI; JOHN WYETH &

BROTHER LTD (TRADING AS

WYETH

PHARMACEUTICALS) -

MBRETERI E BASHKUAR

(APL: WYETH

PHARMACEUTICALS -

SHBA)

REGJ.

311/17.05.2010 449.86

965 ENBREL

Solution for

injection x

50mg/pre-filled

syringe ETANERCEPT

Box x (4 pre-

filled syringes

and 8 alcohol

swabs)

WYETH EUROPA LTD -

MBRETERI E BASHKUAR

WYETH MEDICA IRELAND -

IRLANDE; VETTER PHARMA-

FERTIGUNG GMBH & CO.

KG - GJERMANI; JOHN

WYETH & BROTHER LTD

(TRADING AS WYETH

PHARMACEUTICALS) -

MBRETERI E BASHKUAR

(APL: WYETH

PHARMACEUTICALS -

SHBA)

REGJ.

311/17.05.2010 927.33

966 ENBREL

Solution for

injection x

50mg/pre-filled pen ETANERCEPT

Box x [4 pre-

filled pens

(MYCLIC) and 8

alcohol swabs]

WYETH EUROPA LTD -

MBRETERI E BASHKUAR

WYETH MEDICA IRELAND -

IRLANDE; JOHN WYETH &

BROTHER LTD (TRADING AS

WYETH

PHARMACEUTICALS) -

MBRETERI E BASHKUAR

(APL: WYETH

PHARMACEUTICALS -

SHBA)REGJ.

311/17.05.2010 927.33

Page 127

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128

967 TYGACIL

Powder for solution

for infusion x

50mg/5ml vial TIGECYCLINE Box x 10 vials

PFIZER LIMITED -

MBRETERI E BASHKUAR

WYETH PARENTERALS

DIVISION OF WYETH

HOLDINGS CORPORATION -

PORTO RIKO; JOHN WYETH

& BROTHER LTD (TRADING

AS WYETH

PHARMACEUTICALS) -

MBRETERI E BASHKUAR

(APLIKANT PER

CERTIFIKATE: WYETH

PHARMACEUTICALS INC.-

SHBA); PATHEON ITALIA

S.P.A - ITALI; WYETH

LEDERLE S.P.A - ITALI

REGJ.

311/17.05.2010 450.72

968 PREVENAR

Suspension for

injection x (2µg +

4µg + 2µg + 2µg +

2µg + 2µg + 2µg) /

0.5ml

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 4 +

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 6B +

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 9V +

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 14 +

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 19F +

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 23F +

PNEUMOCOCCAL

OLIGOSACCHARIDE

SEROTYPE 18C

Box x 1 pre-

filled syringe + 1

needle

WYETH LEDERLE

VACCINES SA -

BELGJIKE

WYETH PHARMACEUTICAL

DIVISION OF WYETH

HOLDINGS CORPORATION -

SHBA; JOHN WYETH &

BROTHER LTD - MBRETERI

E BASHKUAR

REGJ.

428/04.08.2009 50.32

Page 128

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129

969 PREVENAR 13

Suspension for

injection x (2.2μg +

2.2μg + 2.2μg +

2.2μg + 2.2μg +

4.4μg + 2.2μg +

2.2μg + 2.2μg +

2.2μg + 2.2μg +

2.2μg + 2.2μg) /

0.5ml

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE: 1¹ + 3¹ + 4¹ + 5¹

+ 6A¹ + 6B¹ + 7F¹ + 9V¹ + 14¹

+ 18C¹ +19A¹ + 19F¹ + 23F¹

[¹Conjugated to CRM

₁₉₇

carrier protein and adsorbed

on aluminium phosphate

(0.125mg aluminium)]

Box x 1 single

dose pre-filled

syringe with

separate needle

PFIZER LIMITED -

MBRETERI E BASHKUAR

WYETH PHARMACEUTICAL,

DIVISION OF WYETH

HOLDINGS CORPORATION -

SHBA; BAXTER

PHARMACEUTICAL

SOLUTIONS LLC - SHBA;

JOHN WYETH & BROTHER

LTD. (TRADING AS WYETH

PHARMACEUTICALS) -

MBRETERI E BASHKUAR

REGJ

298/25.06.2012 50.32

970

GENOTROPIN

GoQuick

Powder and

solvent for solution

for injection x

5.3mg/1ml SOMATROPIN

Box x 1 pre-

filled pen (1ml) PFIZER SA - BELGJIKE

VETTER PHARMA-

FERTIGUNG GMBH & CO KG

(LANGENARGEN SITE) -

GJERMANI; VETTER

PHARMA-FERTIGUNG GMBH

& CO KG (RAVENSBURG

SITE) - GJERMANI; PFIZER

MANUFACTURING BELGIUM

NV - BELGJIKE; (APL:

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE)

REGJ

422/11.07.2013 98

Page 129

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130

971

GENOTROPIN

GoQuick

Powder and

solvent for solution

for injection x

12mg/1ml SOMATROPIN

Box x 1 pre-

filled pen (1ml) PFIZER SA - BELGJIKE

VETTER PHARMA-

FERTIGUNG GMBH & CO KG

(LANGENARGEN SITE) -

GJERMANI; VETTER

PHARMA-FERTIGUNG GMBH

& CO KG (RAVENSBURG

SITE) - GJERMANI; PFIZER

MANUFACTURING BELGIUM

NV - BELGJIKE; (APL:

PFIZER MANUFACTURING

BELGIUM NV - BELGJIKE)

REGJ

422/11.07.2013 225.33

972 BENEFIX

Powder and

solvent for solution

for injection x 250

IU/vial NONACOG ALFA

Box x 1vial with

powder + 1

prefilled syringe

x 5 ml solvent +

1 sterile vial

adapter

reconstitution

device + 1

sterile infusion

set + two

alcohol swabs +

1 plaster + 1

gauze pad

PFIZER LIMITED -

MBRETERI E BASHKUAR WYETH FARMA SA - SPANJE

REGJ

140/19.03.2013 178

Page 130

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131

973 BENEFIX

Powder and

solvent for solution

for injection x 500

IU NONACOG ALFA

Box x (1vial

powder + 1

prefilled syringe

solvent + 1

sterile vial

adapter

reconstitution

device + 1

sterile infusion

set)

PFIZER LIMITED -

MBRETERI E BASHKUAR WYETH FARMA SA - SPANJE

REGJ

451/13.08.2013 356

974 BENEFIX

Powder and

solvent for solution

for injection x 1000

IU/vial NONACOG ALFA

Box x 1vial with

powder + 1

prefilled syringe

x 5 ml solvent +

1 sterile vial

adapter

reconstitution

device + 1

sterile infusion

set + two

alcohol swabs +

1 plaster + 1

gauze pad

PFIZER LIMITED -

MBRETERI E BASHKUAR WYETH FARMA SA - SPANJE

REGJ

140/19.03.2013 712

975 BENEFIX

Powder and

solvent for solution

for injection x 2000

IU NONACOG ALFA

Box x (1vial

powder + 1

prefilled syringe

solvent + 1

sterile vial

adapter

reconstitution

device + 1

sterile infusion

set)

PFIZER LIMITED -

MBRETERI E BASHKUAR WYETH FARMA SA - SPANJE

REGJ

451/13.08.2013 1424

Page 131

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132

976 REFACTO AF

Powder and

solvent for solution

for injection x 250

IU MOROCTOCOG ALFA

Box x (1vial

powder + 1

prefilled syringe

solvent + 1

sterile vial

adapter

reconstitution

device + 1

sterile infusion

set)

PFIZER LIMITED -

MBRETERI E BASHKUAR

WYETH FARMA SA -

SPANJE; VETTER PHARMA -

FERTIGUNG GMBH & CO.KG

- GJERMANI

REGJ

451/13.08.2013 168

977 REFACTO AF

Powder and

solvent for solution

for injection x 500

IU MOROCTOCOG ALFA

Box x (1vial

powder + 1

prefilled syringe

solvent + 1

sterile vial

adapter

reconstitution

device + 1

sterile infusion

set)

PFIZER LIMITED -

MBRETERI E BASHKUAR

WYETH FARMA SA -

SPANJE; VETTER PHARMA -

FERTIGUNG GMBH & CO.KG

- GJERMANI

REGJ

451/13.08.2013 336

978 REFACTO AF

Powder and

solvent for solution

for injection x 1000

IU MOROCTOCOG ALFA

Box x (1vial

powder + 1

prefilled syringe

solvent + 1

sterile vial

adapter

reconstitution

device + 1

sterile infusion

set)

PFIZER LIMITED -

MBRETERI E BASHKUAR

WYETH FARMA SA -

SPANJE; VETTER PHARMA -

FERTIGUNG GMBH & CO.KG

- GJERMANI

REGJ

451/13.08.2013 672

Page 132

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133

979 REFACTO AF

Powder and

solvent for solution

for injection x 2000

IU MOROCTOCOG ALFA

Box x (1vial

powder + 1

prefilled syringe

solvent + 1

sterile vial

adapter

reconstitution

device + 1

sterile infusion

set)

PFIZER LIMITED -

MBRETERI E BASHKUAR

WYETH FARMA SA -

SPANJE; VETTER PHARMA -

FERTIGUNG GMBH & CO.KG

- GJERMANI

REGJ

451/13.08.2013 1344

980 BICAMIDE

Film coated tablets

x 50mg BICALUTAMIDE Box x 28 GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

396/07.07.2009 35

981 MEGAPLATIN

Solution for

infusion x

150mg/15ml CARBOPLATIN

Box x 1 vial x

15ml GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

180/18.03.2009 32

982 SELON

Film coated tablets

x 20mg

CITALOPRAM

HYDROBROMIDE x 25MG

EQUIVALENT TO

CITALOPRAM x 20MG Box x 28 GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

396/07.07.2009 4.35

983 DOXOTIL

Solution for

injection x

10mg/5ml

DOXORUBICIN

HYDROCHLORIDE

Box x 1 vial x

5ml GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

180/18.03.2009 4.98

984 DOXOTIL

Solution for

injection x

10mg/5ml

DOXORUBICIN

HYDROCHLORIDE

Box x 1 vial x

25ml GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

180/18.03.2009 15.06

985 CIAZIL

Solution for

injection x

50mg/25ml

EPIRUBICIN

HYDROCHLORIDE

Box x 1 vial x

25ml GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

180/18.03.2009 35

986 CIAZIL

Solution for

injection x

50mg/25ml

EPIRUBICIN

HYDROCHLORIDE

Box x 1 vial x

5ml GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

180/18.03.2009 6.73

987 MEVASTIN Tablets x 40mg LOVASTATIN Box x 30 GENEPHARM SA - GREQI GENEPHARM SA - GREQI

REGJ.

588/29.10.2010 11

988 BACTALIN

Powder for solution

for injection x (4 +

0.5)g/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

4.17g/vial) + TAZOBACTAM

(as TAZOBACTAM SODIUM

x 0.54g/vial)

Box x 1 glass

vial GENEPHARM SA - GREQI FAMAR S.A. - GREQI

REGJ

526/23.12.2011 8.74

Page 133

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134

989 MYCO-SYNALAR

Ointment for

external use x (3%

+ 0.025%)

CLIOQUINOL +

FLUOCINOLONE

ACETONIDE

Box x 1 tube x

10g

MINERVA

PHARMACEUTICAL SA -

GREQI FAMAR A.V.E. - GREQI

REGJ

596/26.11.2012 1.35

990 SYNALAR SIMPLE Cream x 0.01%

FLUOCINOLONE

ACETONIDE

Box x 1 tube x

15g

MINERVA

PHARMACEUTICAL SA -

GREQI FAMAR A.V.E. - GREQI

REGJ

596/26.11.2012 0.99

991

PROCTO

SYNALAR-N

Rectal cream x

(0.01% + 2%)

FLUOCINOLONE

ACETONIDE + LIDOCAINE

HYDROCHLORIDE

Box x 1 tube x

15g

MINERVA

PHARMACEUTICAL SA -

GREQI FAMAR A.V.E. - GREQI

REGJ

596/26.11.2012 1.4

992 NEO-PRIPHEN

Nasal spray

solution x (1mg/ml

+ 0.5mg/ml +

2.5mg/ml +

0.05mg/ml)

NEOMYCIN SULFATE (eq.

to NEOMYCIN base x

0.75mg/ml) +

NAPHAZOLINE NITRATE +

PHENYLEPHRINE

CHLORHYDRATE +

GRAMICIDIN

Box x 1 bottle x

15ml

MINERVA

PHARMACEUTICAL SA -

GREQI FAMAR A.V.E. - GREQI

REGJ

596/26.11.2012 1.45

993 VOMEX-A

Solution for

injection x

100mg/2ml DIMENHYDRINATE

Box x 5

ampoules x 2ml

OLVOS SCIENCE SA -

GREQI

OLVOS SCIENCE SA -

GREQI; GALENICA SA -

GREQI

REGJ.

156/20.04.2011 2.8

994 AFLEN

Hard capsules x

300mg TRIFLUSAL Box x 50 GALENICA SA - GREQI

J.URIACH & CIA SA -

SPANJE

REGJ.

156/20.04.2011 9.74

995 YUTOPAR Tablets x 10mg

RITODRINE

HYDROCHLORIDE Box x 40 GALENICA SA - GREQI

GALENICA SA - GREQI;

SOLVAY

PHARMACEUTICALS BV

OLST - HOLLANDE

REGJ.

156/20.04.2011 7.36

996 YUTOPAR

Solution for

injection x

50mg/5ml

RITODRINE

HYDROCHLORIDE

Box x 5

ampoules x 5ml GALENICA SA - GREQI

GALENICA SA - GREQI;

FAMAR SA - GREQI

REGJ.

156/20.04.2011 13.25

997 ADAPTOL

Hard capsules x

300mg MEBICARUM Box x 20

JSC OLAINFARM -

LETONI JSC OLAINFARM - LETONI

REGJ

213/09.05.2012 4.5

998 FENKAROL Tablets x 10mg

QUIFENADINE

HYDROCHLORIDE Box x 20

JSC OLAINFARM -

LETONI JSC OLAINFARM - LETONI

REGJ

307/07.05.2013 2.48

999 FURAGIN Tablets x 50mg FURAGIN Box x 30 AS OLAINFARM - LETONI AS OLAINFARM - LETONI

REGJ.

534/15.10.2009 4

1000 FURAMAG

Hard capsules x

50mg FURAGIN Box x 30 AS OLAINFARM - LETONI AS OLAINFARM - LETONI

REGJ.

534/15.10.2009 5.8

Page 134

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135

1001 GRIPOFLEX 500

Powder for oral

solution x (500mg

+ 200mg +

25mg)/sachet

PARACETAMOL +

ASCORBIC ACID +

PHENIRAMINE MALEATE Box x 5 sachets

JSC OLAINFARM -

LETONI JSC OLAINFARM - LETONI

REGJ

307/07.05.2013 2.1

1002 ITRANOL

Hard capsules x

100mg ITRACONAZOLE Box x 10 AS OLAINFARM - LETONI AS OLAINFARM - LETONI

REGJ.

534/15.10.2009 11

1003 NEIROMIDIN Tablets x 20mg IPIDACRINE Box x 50 AS OLAINFARM - LETONI AS OLAINFARM - LETONI

REGJ.

534/15.10.2009 7.8

1004 NEIROMIDIN

Solution for

injection x 5mg/ml IPIDACRINE

Box x 10

ampoules x 1ml AS OLAINFARM - LETONI SOPHARMA JSC - BULLGARI

REGJ

419/12.10.2011 9.99

1005 NEIROMIDIN

Solution for

injection x 15mg/ml IPIDACRINE

Box x 10

ampoules x 1ml AS OLAINFARM - LETONI SOPHARMA JSC - BULLGARI

REGJ

419/12.10.2011 17.2

1006 NOOFEN Tablets x 250mg PHENIBUTUM Box x 20

JSC OLAINFARM -

LETONI JSC OLAINFARM - LETONI

REGJ

140/19.03.2013 8.82

1007 REMAVIR 50MG Tablets x 50mg

RIMANTADINE

HYDROCHLORIDE Box x 20 AS OLAINFARM - LETONI AS OLAINFARM - LETONI

REGJ.

534/15.10.2009 4.6

1008 VAZONAT

Solution for I.V

injection x

100mg/ml MELDONIUM DIHYDRATE

Box x 10

ampoules x 5ml

JSC OLAINFARM -

LETONI SOPHARMA JSC - BULLGARI

REGJ

213/09.05.2012 6

1009 VAZONAT Capsules x 250mg MELDONIUM DIHYDRATE Box x 40

JSC OLAINFARM -

LETONI JSC OLAINFARM - LETONI

REGJ

140/19.03.2013 4.7

1010 BERODUALIN

Solution for

inhalation x

(0.05g/100ml +

0.025g/100ml)

FENOTEROL

HYDROBROMIDE +

IPRATROPIUM

BROMIDE(as

IPRATROPIUM BROMIDE

[H2O] x 0.026g/100ml)

Box x 1 flacon x

20ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

ISTITUTO DE ANGELI SRL -

ITALI

REGJ

70/13.02.2013 4

1011 BISOLVON

Oral solution x

0.2g/100ml

BROMHEXIN

HYDROCHLORIDE

Box x glass

bottle x 100ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

ISTITUTO DE ANGELI SRL -

ITALI

RIREGJ.

458/16.08.2010 3.6

1012 BISOLVON

Oral solution x

0.2g/100ml

BROMHEXIN

HYDROCHLORIDE

Box x 1 glass

bottle x 40ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

ISTITUTO DE ANGELI SRL -

ITALI

RIREGJ.

458/16.08.2010 2.5

Page 135

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136

1013 BISOLVON Tablets x 8mg

BROMHEXINE

HYDROCHLORIDE Box x 20

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

DELPHARM REIMS -

FRANCE

RIREGJ

450/31.10.2011 2.2

1014 BUSCAPINA

Solution for

injection x 20mg/ml

HYOSCINE-N-

BUTYLBROMIDE (in isotonic

aqueous solution containing

sodium chloride)

Box x 5

ampoules x 1ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

BOEHRINGER INGELHEIM

ESPANA SA - SPANJE

RIREGJ

282/07.07.2011 3.72

1015 DULCOLAX

Suppositories x

10mg BISACODYL Box x 6

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

ISTITUTO DE ANGELI SRL -

ITALI

RIREGJ.

458/16.08.2010 2

1016 DULCOLAX

Sugar coated

tablets x 5mg BISACODYL Box x 40

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

DELPHARM REIMS -

FRANCE

RIREGJ

50/04.02.2013 2.5

1017 FINALGON

Ointment x (0.4g +

2.5g) / 100g NONIVAMIDE + NICOBOXIL

Box x 1 tube x

20g

"BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG" - AUSTRI

"HAUPT PHARMA

WOLFRATSHAUSEN GMBH" -

GJERMANI, "GLOBOPHARM

PHARMAZEUTISCHE

PRODUKTIONS- UND

HANDELSGESELLSCHAFT

MBH" - AUSTRI,

"BOEHRINGER INGELHEIM

PHARMA GMBH &CO.KG" -

GJERMANI

RIREGJ

366/23.09.2011 2.5

1018 GLURENORM Tablets x 30mg GLIQUIDONE

Box x 30

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

BOEHRINGER INGELHEIM

ELLAS AE - GREQI;

BOEHRINGER INGELHEIM

PHARMA GMBH & CO. KG. -

GJERMANI

RIREGJ.

713/21.12.2009 4.61

1019

MOVALIS

15MG/1.5ML

Solution for

injection x

15mg/1.5ml MELOXICAM

Box x 3

ampoules x

1.5ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO KG - AUSTRI

BOEHRINGER INGELHEIM

ESPANA SA - SPANJE

RIREGJ.

71/09.02.2010 2.42

Page 136

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137

1020 MOVALIS Tablets x 7.5mg MELOXICAM Box x 30

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI; BOEHRINGER

INGELHEIM ELLAS SA -

GREQI (APL: BOEHRINGER

INGELHEIM PHARMA GMBH

& CO.KG on behalf of

BOEHRINGER INGELHEIM

INTERNATIONAL GMBH -

GJERMANI)

REGJ.

249/21.04.2010 7.2

1021 MOVALIS Tablets x 15mg MELOXICAM Box x 30

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI; BOEHRINGER

INGELHEIM ELLAS SA -

GREQI (APL: BOEHRINGER

INGELHEIM PHARMA GMBH

& CO.KG on behalf of

BOEHRINGER INGELHEIM

INTERNATIONAL GMBH -

GJERMANI)

REGJ.

249/21.04.2010 9.9

1022 MUCOSAN

Solution for

injection x 15mg/

2ml

AMBROXOL

HYDROCHLORIDE

Box x 5

ampoules x 2ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO. KG - AUSTRI

BOEHRINGER INGELHEIM

ESPANA SA - SPANJE

RIREGJ.

71/09.02.2010 5.06

1023 MUCOSOLVAN Syrup x 15mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 100ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

DELTAPHARM REIMS -

FRANCE

RIREGJ

282/07.07.2011 2.8

1024 MUCOSOLVAN Syrup x 15mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 200ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

DELTAPHARM REIMS -

FRANCE

RIREGJ

282/07.07.2011 5

Page 137

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138

1025 MUCOSOLVAN Syrup x 30mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 100ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

DELTAPHARM REIMS -

FRANCE

RIREGJ

282/07.07.2011 3

1026 MUCOSOLVAN Syrup x 30mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 200ml

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

DELTAPHARM REIMS -

FRANCE

RIREGJ

282/07.07.2011 5.2

1027 PRADAXA

Hard capsules x 75

mg

DABIGATRAN ETEXILATE

(as DABIGATRAN

ETEXILATE MESILATE X

86.48 mg) Box x 10

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI)

REGJ.

181/18.03.2009 13.2

1028 PRADAXA

Hard capsules x 75

mg

DABIGATRAN ETEXILATE

(as DABIGATRAN

ETEXILATE MESILATE X

86.48 mg) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI)

REGJ.

181/18.03.2009 36

1029 PRADAXA

Hard capsules x

110 mg

DABIGATRAN ETEXILATE

(as DABIGATRAN

ETEXILATE MESILATE X

126.83 mg) Box x 10

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI)

REGJ.

181/18.03.2009 13.2

1030 PRADAXA

Hard capsules x

110 mg

DABIGATRAN ETEXILATE

(as DABIGATRAN

ETEXILATE MESILATE X

126.83 mg) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI)

REGJ.

181/18.03.2009 36

Page 138

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139

1031 SIFROL Tablets x 0.125mg

PRAMIPEXOLE X 0.088MG

(EQUIVALENT TO

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE X

0.125MG) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG ON

BEHALF OF BOEHRINGER

INGELHEIM INTERNATIONAL

GMBH - GJERMANI)

RIREGJ.

446/26.08.2009 2.67

1032 SIFROL Tablets x 1mg

PRAMIPEXOLE X 0.7MG

(EQUIVALENT TO

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE X 1MG) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG ON

BEHALF OF BOEHRINGER

INGELHEIM INTERNATIONAL

GMBH - GJERMANI)

RIREGJ.

446/26.08.2009 14.9

1033 SIFROL Tablets x 0.25mg

PRAMIPEXOLE X 0.18MG

(EQUIVALENT TO

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE X 0.25MG) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG ON

BEHALF OF BOEHRINGER

INGELHEIM INTERNATIONAL

GMBH - GJERMANI)

RIREGJ.

446/26.08.2009 5.45

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140

1034 SIFROL

Prolonged-release

tablets x 0.26mg

PRAMIPEXOLE (as

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE x

0.375mg) Box x 10

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI

REGJ.

575/28.10.2010 9.49

1035 SIFROL

Prolonged-release

tablets x 0.52mg

PRAMIPEXOLE (as

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE x 0.75mg) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI

REGJ.

575/28.10.2010 49.79

1036 SIFROL

Prolonged-release

tablets x 2.1mg

PRAMIPEXOLE (as

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE x 3mg) Box x 30

BOEHRINGER

INGELHEIM

INTERNATIONAL GMBH -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI

REGJ.

575/28.10.2010 138.86

1037 SPIRIVA

Inhalation powder,

hard capsules x

0.018mg

TIOTROPIUM (eq. to 22.5μg

TIOTROPIUM BROMIDE

MONOHYDRATE)

Box x 30

capsules (3

blister strips)

BOEHRINGER

INGELHEIM PHARMA

GMBH & CO. KG -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI; (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH&CO.KG on

behalf of BOEHRINGER

INGELHEIM INTERNATIONAL

GMBH - GJERMANI)

REGJ

70/13.02.2013 34.5

1038 SPIRIVA

Inhalation powder,

hard capsules x

0.018mg

TIOTROPIUM (eq. to 22.5μg

TIOTROPIUM BROMIDE

MONOHYDRATE)

Box x 30

capsules (3

blister strips)

and HandiHaler

device

BOEHRINGER

INGELHEIM PHARMA

GMBH & CO. KG -

GJERMANI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI; (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH&CO.KG on

behalf of BOEHRINGER

INGELHEIM INTERNATIONAL

GMBH - GJERMANI)

REGJ

70/13.02.2013 34.5

Page 140

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141

1039

METRONIDAZOL

500 MG

INFUSIONSLOSU

NG ALLEMAN

Solution for

infusion x 5.00

g/1000 ml

METRONIDAZOLEBox x 10 glass

bottles x 100 ml

ALLEMAN PHARMA

GmbH - GJERMANI

DIACO SPA - ITALI,

THERASELECT GMBH -

GJERMANI

Riregj.

476/09.09.2013

13

1040

METRONIDAZOL

500 MG

INFUSIONSLOSU

NG ALLEMAN

Solution for

infusion x 5.00

g/1000 ml

METRONIDAZOLEBox x 20 glass

bottle x 100ml

ALLEMAN PHARMA

GmbH - GJERMANI

DIACO SPA - ITALI,

THERASELECT GMBH -

GJERMANI

Riregj.

476/09.09.2013

26

1041 BRON-HAL Syrup x 4mg/5ml

BROMHEXINE

HYDROCHLORIDE X

0.8MG/ML

Box x flacon x

100ml HELP SA - GREQI HELP SA - GREQI

RIREGJ.

668/2.12.2008 0.96

1042 ABROBION Syrup x 30mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 125ml HELP SA - GREQI HELP SA - GREQI

REGJ

422/11.07.2013 2.2

1043 BETRIMINE

Syrup x (10mg +

10mg + 0.1mg)/5ml

THIAMINE

HYDROCHLORIDE +

PYRIDOXINE +

HYDROCHLORIDE +

CYANOCOBALAMIN

Box x 1 bottle x

150ml HELP SA - GREQI HELP SA - GREQI

RIREGJ.

182/18.03.2009 1.3

1044 BETRIMINE

Solution for

injection x (250mg

+ 250mg +

2mg)/5ml

THIAMINE

HYDROCHLORIDE +

PYRIDOXINE

HYDROCHLORIDE +

CYANOCOBALAMINE

Box x 6

ampoules HELP SA - GREQI HELP SA - GREQI

REGJ

422/11.07.2013 3.2

1045 BIOSETRON

Film-coated tablets

x 8mg

ONDANSETRON (AS

ONDANSETRON

HYDROCHLORIDE

DEHYDRATE x 10mg) Box x 15 MEDICUS SA - GREQI HELP SA - GREQI

RIREGJ.

645/10.12.2010 9

1046 BIOSETRON

Solution for

injection x 4mg/2ml

ONDANSETRON x 2mg/ml

(AS ONDANSETRON

HYDROCHLORIDE x

2.5mg/ml) Box x 1 vial MEDICUS SA - GREQI HELP SA - GREQI

RIREGJ.

645/10.12.2010 3.5

1047 BIOSETRON

Solution for

injection x 8mg/4ml

ONDANSETRON x 2mg/ml

(AS ONDANSETRON

HYDROCHLORIDE x

2.5mg/ml) Box x 1 vial MEDICUS SA - GREQI HELP SA - GREQI

RIREGJ.

645/10.12.2010 4

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142

1048 BIOSONIDE

Inhalation

suspension x

0.5mg/2ml BUDESONIDE

Box x 20 plastic

vials x 2ml HELP SA - GREQI

GENETICS SPA - ITALI;

HELP SA - GREQI

REGJ

422/11.07.2013 9

1049 BIOSONIDE

Inhalation

suspension x

1mg/2ml BUDESONIDE

Box x 20 plastic

vials x 2ml HELP SA - GREQI

GENETICS SPA - ITALI;

HELP SA - GREQI

REGJ

422/11.07.2013 11.3

1050 DUOBETIC

Eye drops, solution

x 2% (w/v) CROMOGLYCATE SODIUM

Box x flacon x

5ml HELP SA - GREQI HELP SA - GREQI

RIREGJ

190/27.04.2012 1.1

1051 INESTOM

Solution for

injection x 1g/5ml LEVOCARNITINE

Box x 5

ampoules x 5ml HELP SA - GREQI HELP SA - GREQI

REGJ.

181/18.03.2009 2.59

1052 PTINOLIN

Solution for

injection x

50mg/2ml

RANITIDINE (as

RANITIDINE

HYDROCHLORIDE x

27.90mg/1ml)

Box x 5

ampoules x 2ml HELP SA - GREQI HELP SA - GREQI

RIREGJ.

182/18.03.2009 1.5

1053 VURDON

Slow release film

coated tablets x

100mg DICLOFENAC SODIUM Box x 10 HELP SA - GREQI HELP SA - GREQI

RIREGJ.

668/2.12.2008 0.78

1054 VURDON

Gel for external

use x 1% (w/w)

DICLOFENAC SODIUM (as

DICLOFENAC

DIETHYLAMMONIUM x 11.6

mg/g)

Box x tube x

25g HELP SA - GREQI HELP SA - GREQI

RIREGJ

430/24.10.2011 0.9

1055 VURDON

Gel for external

use x 1% (w/w)

DICLOFENAC SODIUM (as

DICLOFENAC

DIETHYLAMMONIUM x 11.6

mg/g)

Box x tube x

100g HELP SA - GREQI HELP SA - GREQI

RIREGJ

430/24.10.2011 3

1056 VURDON

Cutaneous solution

x 1.5% (w/w)

DICLOFENAC SODIUM (15

mg/g)

Box x 1 plastic

vial x 30ml HELP SA - GREQI HELP SA - GREQI

REGJ

422/11.07.2013 5

1057 VURDON

Solution for

injection x

75mg/3ml DICLOFENAC SODIUM

Box x 5

ampoules HELP SA - GREQI HELP SA - GREQI

REGJ

422/11.07.2013 3

1058 ZITHROXYN

Film coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524mg) Box x 3 HELP SA - GREQI

RAFARM A.E.B.E - GREQI;

HELP SA - GREQI

REGJ

422/11.07.2013 4

1059 IPERTROFAN

Gastroresistant

tablets x 40mg MEPARTRICINE Box x 20

SPA - SOCIETA'

PRODOTTI ANTIBIOTICI

S.P.A. - ITALI

DOPPEL FARMACEUTICI

S.P.A. - ITALI

REGJ.

396/07.07.2009 18

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143

1060

BRONCHOTUSSIN

ESyrup x 4mg/5ml

BROMHEXINE

HYDROCHLORIDE

Box x 1 plastic

bottle x 100ml

ADELCO-

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO-CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS SA -

GREQI

REGJ.

156/20.04.2011

1.3

1061 DISTEDON

Coated tablets x (2

+ 2.5)mg

DIAZEPAM + CLIDINIUM

BROMIDE Box x 30

ADELCO-

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO-CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS SA -

GREQI

REGJ

527/23.12.2011 2.5

1062 ISTAMEX Syrup x 2mg/5ml

CHLORPHENIRAMINE

MALEATE

Box x 1 bottle x

100ml

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

S.A. - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

S.A. - GREQI

REGJ.

181/18.03.2009 1.5

1063 ISTAMEX Tablets x 4mg

CHLORPHENIRAMINE

MALEATE Box x 20

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

SA - GREQI

REGJ.

565/27.10.2009 0.75

1064

NEO-

MYCODERMOL

Cream x 1%

(10mg/g) CICLOPIROX OLAMINE

Box x 1 tube x

20g

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

SA - GREQI

REGJ.

369/17.06.2009 1.8

1065

NEO-

MYCODERMOL

Solution for

external use x 1%

(10mg/ml) CICLOPIROX OLAMINE

Box x 1 bottle x

20ml

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

SA - GREQI

REGJ.

369/17.06.2009 1.8

1066

ANABOLINE

DEPOT

Oily solution for

injection x

50mg/1ml AMP

NANDROLONE

DECANOATE

Box x 1

ampoule x 1ml

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

SA - GREQI

REGJ.

369/17.06.2009 1.99

1067 DERMOL

Ointment x (0.5% +

0.5%) (w/w)

PREDNISOLONE +

NEOMYCIN SULPHATE

Box x tube x

20g

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

SA - GREQI

REGJ.

286/11.05.2009 1.4

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144

1068 DERMOL

Cream x (0.5% +

0.5%) (w/w)

PREDNISOLONE +

NEOMYCIN SULPHATE

Box x tube x

20g

ADELCO -

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO -

CHROMATOURGIA ATHINON

E. COLOCOTRONIS BROS

SA - GREQI

REGJ.

286/11.05.2009 1.4

1069 PAROTICIN

Ear drops solution

x (1mg + 1.3mg +

50mg)/1ml

FLUDROCORTISONE

ACETATE + POLYMYXIN B

SULPHATE (eq. to

POLYMYXIN B x 10000 IU) +

LIDOCAINE

HYDROCHLORIDE

Box x 1 flacon x

10ml

ADELCO-

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO-CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS SA -

GREQI

RIREGJ

325/15.05.2013 1.7

1070 MINITRAN

Coated tablets x

(10 + 2)mg

AMITRIPTYLINE

HYDROCHLORIDE +

PERPHENAZINE Box x 50

ADELCO-

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO-CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS SA -

GREQI

REGJ

527/23.12.2011 4.7

1071 MINITRAN

Coated tablets x

(25 + 4)mg

AMITRIPTYLINE

HYDROCHLORIDE +

PERPHENAZINE Box x 50

ADELCO-

CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS

SA - GREQI

ADELCO-CHROMATOURGIA

ATHINON E.

COLOCOTRONIS BROS SA -

GREQI

REGJ

527/23.12.2011 7.7

1072

BROMEX Syrup x 5mg/5mlBROMHEXINE

HYDROCHLORIDE

Box x 1 flacon x

180ml

LABORATORIA

QUALIPHAR NV/SA -

BELGJIKE

LABORATORIA QUALIPHAR

NV/SA - BELGJIKE

REGJ.

308/07.05.2013;

Nd.U.477/09.09.20133.99

1073 PE-TAM ADULTS Tablets x 500mg PARACETAMOL Box x 20

LABORATORIA

QUALIPHAR NV/SA -

BELGJIKE

LABORATORIA QUALIPHAR

NV/SA - BELGJIKE

REGJ

308/07.05.2013 1.15

1074 PURGO-PIL

Gastro-resistant

tablets x 10mg BISACODYL Box x 30

LABORATORIA

QUALIPHAR NV/SA -

BELGJIKE

LABORATORIA QUALIPHAR

NV/SA - BELGJIKE

REGJ

308/07.05.2013 1.98

1075

VASOCEDINE

NAPHAZOLINE

Nasal spray

solution x

0.1%(w/w) NAPHAZOLINE NITRATE

Box x 1 vial x

15ml

LABORATORIA

QUALIPHAR NV/SA -

BELGJIKE

LABORATORIA QUALIPHAR

NV/SA - BELGJIKE

REGJ

308/07.05.2013 2.45

1076

VITAMINE C

QUALIPHAR

Compressed

lozenges x 500mg

ASCORBIC ACID 375.3MG -

CALCIUM ASCORBATE

152MG Box x 60

LABORATORIA

QUALIPHAR NV/SA -

BELGJIKE

LABORATORIA QUALIPHAR

NV/SA - BELGJIKE

REGJ

308/07.05.2013 4.12

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145

1077 BETABIOPTAL

Ophthalmic

ointment x 0.2% +

0.5%

BETAMETHASONE +

CHLORAMPHENICOL

Box x 1 tube x

5g

FARMILA - THEA

FARMACEUTICI SPA -

ITALI

FARMILA - THEA

FARMACEUTICI SPA - ITALI

RIREGJ

351/31.07.2012 3.6

1078 BETABIOPTAL

Ophthalmic

suspension x 0.2%

+ 0.5%

BETAMETHASONE +

CHLORAMPHENICOL

Box x 1 flacon x

5g

FARMILA - THEA

FARMACEUTICI SPA -

ITALI

FARMILA - THEA

FARMACEUTICI SPA - ITALI

RIREGJ

351/31.07.2012 3.6

1079 BIORINIL

Nasal spray,

suspension x

0.05% + 0.1%

BETAMETHASONE +

TETRAHYDROZOLINE

HYDROCLORIDE

Box x 1 flacon x

10ml

FARMILA - THEA

FARMACEUTICI SPA -

ITALI

FARMILA - THEA

FARMACEUTICI SPA - ITALI

RIREGJ

351/31.07.2012 4.2

1080 OTIPAX

Solution for

auricular instillation

x (4g + 1g)/100g

PHENAZONE + LIDOCAINE

HYDROCHLORIDE

Box x 1 glass

vial of 15ml

(contains 16g of

solution) BIOCODEX - FRANCE BIOCODEX - FRANCE

RIREGJ

598/26.11.2012 2.31

1081 BIOFLOR 250mg

Powder for oral

suspension x

282.5mg/sachet

LYOPHILIZED

SACCHAROMYCES

BOULARDII (MIXTURE OF

250MG OF LYOPHILIZED

YEAST CELLS WITH

32.5MG OF LACTOSE)

Box x 10

sachets BIOCODEX - FRANCE BIOCODEX - FRANCE

RIREGJ

50/04.02.2013 3.15

1082 BIOFLOR 250mg

Capsules x

282.5mg

LYOPHILIZED

SACCHAROMYCES

BOULARDII (MIXTURE OF

250MG OF LYOPHILIZED

YEAST CELLS WITH

32.5MG OF LACTOSE)

Box x 1 plastic

bottle x 10 BIOCODEX - FRANCE BIOCODEX - FRANCE

RIREGJ

50/04.02.2013 3.12

1083 STIMOL

Oral solution in

sachet x 1g/10ml CITRULLINE MALATE

Box x 18

sachets BIOCODEX - FRANCE BIOCODEX - FRANCE

RIREGJ

266/19.04.2013 4.51

1084 STRESAM Capsules x 50mg

ETIFOXINE

HYDROCHLORIDE Box x 24 BIOCODEX - FRANCE BIOCODEX - FRANCE

RIREGJ

297/18.07.2011 2.25

1085 ACUPAN

Solution for

injection x

20mg/2ml

NEFOPAM

HYDROCHLORIDE

Box x 5

ampoules x 2ml "BIOCODEX" - FRANCE "BIOCODEX" - FRANCE

RIREGJ

372/27.09.2011 3.31

1086 ANTARENE

Oral suspension x

20mg/ml IBUPROFENE

Box x 1 flacon x

150ml

LABORATOIRES ELERTE

- FRANCE

LABORATOIRES ELERTE -

FRANCE

REGJ

334/29.08.2011 1.384

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146

1087 ANTARENE Gel x 5% IBUPROFENE

Box x 1 tube x

50g

LABORATOIRES ELERTE

- FRANCE

LABORATOIRE

PHARMADEVELOPPEMENT -

FRANCE

REGJ

334/29.08.2011 1.61

1088 ACTICARBINE

Coated tablets x

(70mg + 14mg)

ACTIVATED CHARCOAL +

PAPAVERINE

HYDROCHLORIDE Box x 42

LABORATOIRES ELERTE

- FRANCE

LABORATOIRES ELERTE -

FRANCE

REGJ

334/29.08.2011 1.85

1089

ANTARENE

CODEINE

Coated tablets x

(200mg + 30mg)

IBUPROFEN + CODEINE (as

SEMUHYDRATED

CODEINE PHOSPHATE) Box x 20

LABORATORIES ELERTE

- FRANCE

LABORATORIES ELERTE -

FRANCE

REGJ

604/27.11.2012 3

1090

FOSTIMON

Powder and

solvent for solution

for injection x

150IU/vial

FSH (UROFOLLITROPIN)

Box x 1 vial

(powder) +

ampoule

(solvent)

IBSA INSTITUT

BIOCHIMIQUE SA -

ZVICER

INBSA INSTITUT

BIOCHIMIQUE SA - ZVICER;

IBSA FARMACEUTICI ITALIA

SRL - ITALI

REGJ.

307/07.05.2013

12.5

1091

AZITROMICINA

BLUEPHARMA

Coated tablets x

500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524mg)

Box x 3

BLUEPHARMA-

INDUSTRIA

FARMACEUTICA SA -

PORTUGALI

BLUEPHARMA-INDUSTRIA

FARMACEUTICA SA -

PORTUGALI (APL:

BLUEPHARMA-INDUSTRIA

FARMACEUTICA SA -

PORTUGALI)

REGJ.

646/10.12.2010

3.3

1092

BONDRONAT

Concentrate for

solution for infusion

x 6mg/6ml

IBANDRONIC ACID (as

IBANDRONIC ACID, MONO-

SODIUM SALT

MONOHYDRATE x

6.75mg/6ml)

Box x 1 vial x

6ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

ROCHE DIAGNOSTICS

GMBH - GJERMANI; APL: F.

HOFFMANN-LA ROCHE LTD -

ZVICER)

RIREGJ.

109/01.03.2013

135

1093

BONDRONAT

Concentrate for

solution for infusion

x 2mg/2ml

IBANDRONIC ACID Box x 1 vial x

2ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

ROCHE DIAGNOSTICS

GMBH - GJERMANI; dhe me

aplikant per çertifikate F.

HOFFMANN-LA ROCHE LTD -

ZVICER)

Regj. 654/03.12.2013

84.1

1094 CALSAL

Nasal spray

solution x

100IU/dose

CALCITONIN SALMON 1100

IU/ML

Box x 1 glass

bottle with a

pump x 4ml (28

doses) BALU LTD - GREQI

PHARMACEUTICAL

INDUSTRY PROEL S.A. -

GREQI; RAFARM A.E.B.E. -

GREQI

REGJ.

565/27.10.2009 8.2

Page 146

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147

1095VITAMIN B6 Tablets x 25mg

PYRIDOXINE

HYDROCHLORIDEBox x 60

NOVAL SH.P.K. -

SHQIPËRI NOVAL SH.P.K. - SHQIPËRI REGJ. 45/30.01.2012 132

1096VITAMIN B1 Tablets x 10mg

THIAMINE

HYDROCHLORIDEBox x 60

NOVAL SH.P.K. -

SHQIPËRI NOVAL SH.P.K. - SHQIPËRI REGJ. 45/30.01.2012 130

1097CALCIRAD Tablets x 500mg CALCIUM GLUCONATE Box x 20

NOVAL SH.P.K. -

SHQIPËRI NOVAL SH.P.K. - SHQIPËRI

REGJ.

206/20.05.2011 146

1098

RAD-ASPIRINA Tablets x 500mg ACETYLSALICYLIC ACID Box x 60

NOVAL SH.P.K. -

SHQIPËRI NOVAL SH.P.K. - SHQIPËRI

REGJ.

45/30.01.2012;

(variacion nr.425/1,

dt.13.06.2013

146

1099

ESOMEPRAZOLGastro-resistant

tablets x 20mgESOMEPRAZOLE Box x 30 "NOVAL SHPK" SHQIPERI

"NOVAL SHPK" SHQIPERI;

"VALPHARMA S.P.A" SAN

MARINO

Regj.451/13.08.2013

1700

1100

ESOMEPRAZOLGastro-resistant

tablets x 40mgESOMEPRAZOLE Box x 30 "NOVAL SHPK" SHQIPERI

"NOVAL SHPK" SHQIPERI;

"VALPHARMA S.P.A" SAN

MARINO

Regj.451/13.08.2013

2214

1101 LOMEXIN Cream x 2 % FENTICONAZOLE NITRATE

Box x 1 tube x

30g

RECORDATI INDUSTRIA

CHIMICA E

FARMACEUTICA SPA -

ITALI

RECORDATI INDUSTRIA

CHIMICA E FARMACEUTICA

SPA - ITALI

REGJ.

180/18.03.2009 1.6

1102 LOMEXIN

Vaginal cream x

2% FENTICONAZOLE NITRATE

Box x 1 tube x

78g with

applicator

RECORDATI INDUSTRIA

CHIMICA

FARMACEUTICA SPA -

ITALI

RECORDATI INDUSTRIA

CHIMICA FARMACEUTICA

SPA - ITALI

REGJ.

156/20.04.2011 3.19

1103 GENURIN

Film coated tablets

x 200mg

FLAVOXATE

HYDROCHLORIDE Box x 30

RECORDATI INDUSTRIA

CHIMICA E

FARMACEUTICA SPA -

ITALI

RECORDATI INDUSTRIA

CHIMICA E FARMACEUTICA

SPA - ITALI

REGJ.

180/18.03.2009 2.97

1104LOPERAMID Tablets x 2mg LOPERAMIDE Box x 30 "NOVAL SHPK" SHQIPERI "NOVAL SHPK" SHQIPERI

Regj.

384/ 17.06.2013 255

1105

LOPERAMID-1A

PHARMA

Hard capsules x

2mg

LOPERAMIDE

HYDROCHLORIDEBox x 20

1A PHARMA GMBH -

GJERMANI

SALUTAS PHARMA GMBH -

GJERMANI

REGJ.

664/21.12.2010 1.05

1106

NORADOXBreakable tablets x

2mg

DOXAZOSINE (as

DOXAZOSINE MESYLATE x

2.43mg)

Box x 30BENEDETTI & CO. SPA -

ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

690/16.12.20098

1107

NORADOXBreakable tablets x

4mg

DOXAZOSINE (as

DOXAZOSINE MESYLATE x

4.85mg)

Box x 20BENEDETTI & CO. SPA -

ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

690/16.12.20098

Page 147

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148

1108

AUGMENTIN

Powder for oral

suspension x

(200mg +

28.5mg)5ml

AMOXICILLIN +

CLAVULANIC ACID

Box x 1 flacon x

70ml

SMITHKLINE BEECHAM -

MBRETERI E BASHKUAR

SMITHKLINE BEECHAM -

MBRETERI E BASHKUAR

(APL. PER CERT.:

SMITHKLINE BEECHAM

PHARMACEUTICALS -

MBRETERI E BASHKUAR)

RIREGJ.

633/20.11.2013

3.68

1109

FRAXIPARINE

Solution for

injection x 5700 IU

Axa/0.6ml

NADROPARIN CALCIUM

Box x 10

prefilled

syringes

LABORATOIRE

GLAXOSMITHKLINE-

FRANCE

GLAXO WELLCOME

PRODUCTION - FRANCE

RIREGJ.

663/06.12.201356

1110

FRAXIPARINE

Solution for

injection x 3800 IU

Axa/0.4ml

NADROPARIN CALCIUM

Box x 10

prefilled

syringes

LABORATOIRE

GLAXOSMITHKLINE-

FRANCE

GLAXO WELLCOME

PRODUCTION - FRANCE

RIREGJ.

663/06.12.201335

1111

FRAXIPARINE

Solution for

injection x 2850 IU

Axa/0.3ml

NADROPARIN CALCIUM

Box x 10

prefilled

syringes

LABORATOIRE

GLAXOSMITHKLINE-

FRANCE

GLAXO WELLCOME

PRODUCTION - FRANCE

RIREGJ.

663/06.12.201328

1112 SEBIVO

Film-coated tablets

x 600 mg TELBIVUDINE Box x 28

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER dhe me aplikant

per certifikate NOVARTIS

PHARMA AG - ZVICER

RIREGJ.

633/20.11.2013

373.58

1113

AMINOPHYLLINE

DEMO

Solution for

injection x

250mg/10ml

AMINOPHYLLINE

DIHYDRATE

Box x 10 plastic

vials x 10mlDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

351/31.07.20122.43

1114SERACTIL FORTE

Film-coated tablets

x 400mgDEXIBUPROFEN Box x 30

GEBRO PHARMA GMBH -

AUSTRI

GEBRO PHARMA GMBH -

AUSTRI

RIREGJ.

584/29.10.2010 5.4

1115

PRIMAGAL

Powder for solution

for injection x (500

+ 500)mg/vial

IMIPENEM (as IMIPENEM

MONOHYDRATE x

530mg/vial) + CILASTATIN

(as CILASTATIN SODIUM x

530mg/vial)

Box x 1 vial

DEMO SA

PHARMACEUTICAL

INDUSTRY - GREQI

DEMO SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

188/12.05.2011

15

1116

TAZOREX

Powder for solution

for injection x (2 +

0.25)g/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

2.08g/vial) + TAZOBACTAM

(as TAZOBACTAM SODIUM

x 0.27g/vial)

Box x 1 vial

DEMO SA

PHARMACEUTICAL

INDUSTRY - GREQI

FAMAR SA - GREQI; DEMO

SA PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

189/12.05.2011

8

Page 148

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149

1117

TAZOREX

Powder for solution

for injection x (4 +

0.5)g/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

4.17g/vial) + TAZOBACTAM

(as TAZOBACTAM SODIUM

x 0.54g/vial)

Box x 1 vial

DEMO SA

PHARMACEUTICAL

INDUSTRY - GREQI

FAMAR SA - GREQI; DEMO

SA PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

189/12.05.2011

15

1118

VERALOX

Powder and

solvent for solution

for injection x

40mg/vial

OMEPRAZOLE (as

OMEPRAZOLE SODIUM x

42.6mg/vial)

Box x 1 vial of

powder + 1

glass ampoule x

10ml solvent

DEMO SA

PHARMACEUTICAL

INDUSTRY - GREQI

DEMO SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

189/12.05.2011

5

1119

ZILISTEN

Powder for solution

for injection x

750mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM x

877mg/vial)

Box x 1 vial DEMO SA - GREQI DEMO SA - GREQIREGJ.

331/29.08.2011

2.49

1120

LEMOXOL

Powder for solution

for injection x 1

g/vial

CEFTAZIDIME (as

CEFTAZIDIME

PENTAHYDRATE x 1160

mg)

Box x 1 Vial DEMO SA - GREQI DEMO SA - GREQIREGJ.

715/24.12.2008

8.8

1121

ZILISTEN

Powder for solution

for injection x 1500

mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM x

1755 mg)

Box x 1 Vial DEMO SA - GREQI DEMO SA - GREQIREGJ.

715/24.12.2008

2.8

1122

UFEXILSolution for I.V.

infusion x 2mg/ml

CIPROFLOXACIN

(equivalent to

CIPROFLOXACIN LACTATE

x 2.55mg/ml)

Box x 1 PP

Bottles x 100mlDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

447/26.08.2009

5

1123 UFEXIL

Solution for I.V.

infusion x 2mg/ml

CIPROFLOXACIN

(equivalent to

CIPROFLOXACIN LACTATE

x 2.55mg/ml)

Box x 10 PP

Bottles x 50ml DEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

447/26.08.2009 102.8

1124

DEXTROSE 5%Solution for IV

infusion x 5% (w/v)

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Bottles x 100ml DEMO SA - GREQI DEMO SA - GREQIRIREGJ. 433/2 Dt.

28.09.2012

0.65

1125

DEXTROSE 5%Solution for IV

infusion x 5% (w/v)

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Bottles x 250ml, DEMO SA - GREQI DEMO SA - GREQIRIREGJ. 433/2 Dt.

28.09.2012

0.65

Page 149

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150

1126

DEXTROSE 5%Solution for IV

infusion x 5% (w/v)

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Bottles x 500ml, DEMO SA - GREQI DEMO SA - GREQIRIREGJ. 433/2 Dt.

28.09.2012

0.71

1127

DEXTROSE 5%Solution for IV

infusion x 5% (w/v)

GLUCOSE (eq. to GLUCOSE

MONOHYDRATE x

55g/1000ml)

Bottles x

1000ml DEMO SA - GREQI DEMO SA - GREQI

RIREGJ. 433/2 Dt.

28.09.2012

1.1

1128

MANNITOL DEMO

Solution for

infusion x

200mg/ml

MANNITOLBox x bottle x

250mlDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

351/31.07.20122

1129

MANNITOL DEMO

Solution for

infusion x

200mg/ml

MANNITOLBox x bottle x

500ml DEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

351/31.07.20122.5

1130

DEMERGIN

Solution for

injection x

0.2mg/ml

METHYLERGOMETRINE

MALEATE

Box x 5

ampoulesDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

447/26.08.20091.315

1131

COLPOCIN-T

Solution for

intravenous

infusion x

500mg/100ml

METRONIDAZOLE Bottle x 100ml DEMO SA - GREQI DEMO SA - GREQIREGJ.

358/10.06.2009

1.5

1132

OXISEPT 7.5%Cutaneous solution

x 75mg/ml

POVIDONE IODINE

(equivalent to IODINE x

7.5mg/ml)

Box x plastic

flacon x 100mlDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

447/26.08.20094.5

1133

OXISEPT 10%Cutaneous solution

x 100mg/ml

POVIDONE IODINE

(equivalent to IODINE x

10mg/ml)

Box x plastic

flacon x 240mlDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

447/26.08.20091.45

1134

SODIUM

CHLORIDE

INJECTION/DEMO

Solution for IV

infusion x 0.9%

(w/v)

SODIUM CHLORIDE Bottles x 100ml DEMO SA - GREQI DEMO SA - GREQIRIREGJ. 433/2 Dt.

28.09.2012

0.6

1135

SODIUM

CHLORIDE

INJECTION/DEMO

Solution for IV

infusion x 0.9%

(w/v)

SODIUM CHLORIDE Bottles x 250ml DEMO SA - GREQI DEMO SA - GREQIRIREGJ. 433/2 Dt.

28.09.2012

0.58

1136

SODIUM

CHLORIDE

INJECTION/DEMO

Solution for IV

infusion x 0.9%

(w/v)

SODIUM CHLORIDE Bottles x 500ml DEMO SA - GREQI DEMO SA - GREQIRIREGJ. 433/2 Dt.

28.09.2012

0.7

Page 150

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151

1137

SODIUM

CHLORIDE

INJECTION/DEMO

Solution for IV

infusion x 0.9%

(w/v)

SODIUM CHLORIDEBottles x

1000ml DEMO SA - GREQI DEMO SA - GREQI

RIREGJ. 433/2 Dt.

28.09.2012

1.1

1138

LACTATED

RINGER'S

INJECTION/ DEMO

Solution for IV

infusion x (0.32 +

0.6 + 0.04 +

0.027)% (w/v)

SODIUM LACTATE +

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE

Plastic bottle x

500 ml;DEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

50/04.02.2013

0.77

1139

LACTATED

RINGER'S

INJECTION/ DEMO

Solution for IV

infusion x (0.32 +

0.6 + 0.04 +

0.027)% (w/v)

SODIUM LACTATE +

SODIUM CHLORIDE +

POTASSIUM CHLORIDE +

CALCIUM CHLORIDE

DIHYDRATE

Plastic bottle x

1000 mlDEMO SA - GREQI DEMO SA - GREQI

RIREGJ.

50/04.02.2013

1.14

1140

HERPESAN GELGel x (0.15g +

0.3g)/100g

ZINC SULPHATE

HEPTAHYDRATE +

ACHILLEA MILLEFOLIUM

AETHEROLEUM

Box x 1 tube x

7gFITOFARM - MAQEDONI FITOFARM - MAQEDONI

REGJ.

153/04.03.2009

2.75

1141

MEDOPRIM

Syrup x (2g + 3g +

0.005g +

10g)/100g

PRIMULAE LIQUID

EXTRACT + THYME

TINCTURA+ MENTHOL +

MELLA

Box x 1 bottle x

120gFITOFARM - MAQEDONI FITOFARM - MAQEDONI

REGJ.

153/04.03.2009

1.88

1142

IVILEN Syrup x (0.7g + 3g

+ 0.005g)/100ml

HEDERA HELIX SICC.100%

NATIVE (HERBAL EXTRACT

4-8:1) + THYME TINCTURA

+ MENTHOL

Box x 1 bottle x

100mlFITOFARM - MAQEDONI FITOFARM - MAQEDONI

REGJ.

153/04.03.2009

4.5

1143

ECHINAVIT CSyrup x (0.8g + 2g

+ 2g + 0.7g)/100g

ECHINACEA PURPUREA

(HERBAL EXTRACT 4:1) +

ALTHAEA EXTRACT +

THYME EXTRACT +

ASCORBIC ACID

Box x 1 bottle x

130gFITOFARM - MAQEDONI FITOFARM - MAQEDONI

REGJ.

153/04.03.2009

3.25

1144

BETOPTIC S

Eye drops,

suspension x

2.5mg/ml

BETAXOLOL (AS

BETAXOLOL

HYDROCHLORIDE x 2.8mg)

Box x 1 flacon x

5ml

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

RIREGJ.

455/06.08.2010

1.82

Page 151

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152

1145

AZARGA

Eye drops

suspension x

(10mg + 5mg) / ml

BRINZOLAMIDE + TIMOLOL

(as TIMOLOL MALEATE)

Box x 1 vial x

5ml

ALCON LABORATORIES

(UK) LTD - MBRETERI E

BASHKUAR

S.A. ALCON-COUVREUR NV -

BELGJIKE

REGJ.

448/26.08.2009

12.08

1146

MAXITROL

Eye drops,

suspension x (1mg

+ 3500I.U.+

6000I.U)/ml

DEXAMETHASONE +

NEOMYCIN SULFATE +

POLYMYXIN B SULFATE

Box x 1 flacon x

5ml

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

RIREGJ.

455/06.08.2010

1.34

1147

MAXITROL

Sterile ophtalmic

ointment x (1mg +

3500 IU + 6000

IU)/1g

DEXAMETHASONE +

NEOMYCIN SULPHATE +

POLYMYXIN B SULPHATE

Box x 1 tube x

3.5g

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

RIREGJ.

458/16.08.2010

1.34

1148

TEARS

NATURALE II

Eye drops, solution

x (1mg + 3mg)/ml

DEXTRAN 70 +

HYDROXYPROPYL

METHYLCELLULOSE

(4000mPa.s)

Box x 1 flacon x

15ml

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

RIREGJ.

455/06.08.2010

1.51

1149

PATANOLEye Drops Solution

x 1 mg/ml

OLOPATADINE (as

OLOPATADINE

HYDROCHLORIDE X

1.11MG/ML)

Box x 1 flacon x

5ml

ALCON LABORATORIES

(UK) LTD - MBRETERI E

BASHKUAR

S.A.. ALCON-COUVREUR

N.V. - BELGJIKE, ALCON

CUSI S.A. - SPANJE

RIREGJ.

223/08.04.2009

5.17

1150

ALCAINESterile ophtalmic

solution x 0.5%

PROPARACAINE

HYDROCHLORIDE

Box x 1 flacon x

15ml

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

RIREGJ.

458/16.08.20102.1

1151

CUSICROM 4%Eye drops, solution

x 40mg/ml SODIUM CROMOGLYCATE

Box x 1 flacon x

10ml

ALCON CUSI SA -

SPANJEALCON CUSI SA - SPANJE

RIREGJ.

447/03.08.20101.51

1152

CILOXANSterile ophtalmic

solution x 3mg/ml

CIPROFLOXACIN (as

CIPROFLOXACIN

HYDROCHLORIDE x

3.5mg/ml)

Box x 1 flacon x

5ml

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

S.A. ALCON-COUVREUR

N.V. - BELGJIKË

RIREGJ.

470/31.08.2010

2.1

1153

VIGAMOXEye drops, solution

x 5mg/ml

MOXIFLOXACIN (as

MOXIFLOXACIN

HYDROCHLORIDE)

Box x 1 flacon x

5ml

S.A. ALCON-COUVREUR

N.V - BELGJIKE

ALCON-COUVREUR

BELGJIKE; ALCON CUSI SA -

SPANJE

REGJ.

307/07.05.20135.2

1154

CERVUGID

Pessary x (200mg

+ 500mg + 660000

IU + 15mg)

CHLORAMPHENICOL +

METRONIDAZOLE +

NYSTATIN +

HYDROCORTIZONE

ACETATE

Box x 12 IRCON SRL - RUMANI IRCON SRL - ITALIREGJ.

307/07.05.2013

6.95

Page 152

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153

1155

KELIS

Granules for oral

solution x

80mg/sachet

KETOPROFEN LYSINE

SALT (eq. TO

KETOPROFEN x 50MG)

Box x 30

sachets"EPIFARMA SRL" ITALI

"DOPPEL FARMACEUTICI

SRL" ITALI; "LAMP SAN

PROSPERO SPA" ITALI

Regj.

359/28.05.2013

3.85

1156

FRINEG

Powder and

solvent for solution

for I.M injection x

1g/3.5ml

CEFTRIAXONE (as

CEFTRIAXONE BISODIUM x

1192.8mg)

Box x 1 flacon

with powder + 1

vial with solvent

(Lidocaine

hydrochloride) x

3.5ml

EPIFARMA SRL - ITALI

LABORATORIO

FARMACEUTICO CT SRL -

ITALI, GET SRL - ITALI

REGJ.

392/28.08.2012

4.17

1157

EUMATSolution for

injection x 30mg/ml

KETOROLAC

TROMETHAMINE

Box x 3

ampoules x 1mlEPIFARMA SRL - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

392/28.08.20123.78

1158

AMBROTUS Syrup x 30mg/10mlAMBROXOL

HYDROCHLORIDE

Box x glass

bottle x 200mlEPIFARMA SRL - ITALI

SPECIAL PRODUCT'S LINE

SPA - ITALI

REGJ.

392/28.08.20124.83

1159

ZITROBIOTICFilm coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.1mg)

Box x 3 EPIFARMA SRL - ITALIDOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

392/28.08.20124.95

1160

PROCIFLORFilm coated tablets

x 750mg

CIPROFLOXACIN (as

CIPROFLOXACIN

HYDROCHLORIDE

MONOHYDRATE x 873mg)

Box x 12 EPIFARMA SRL - ITALI

LABORATORIO

FARMACOLOGICO

MILANESE SRL - ITALI

REGJ.

392/28.08.2012

6.8

1161

ANTADYSCoated tablets x

100mgFLURBIPROFEN Box x 15

LABORATOIRE

THERAMEX - MONAKO (e

regjistruar ne France)

LABORATOIRE THERAMEX -

MONAKO, LABORATOIRES

MACORS - FRANCE

REGJ.

432/29.07.2010

2.42

1162

COLPOTROPHINEVaginal soft

capsules x 10mgPROMESTRIENE Box x 10;

LABORATOIRE

THERAMEX - MONAKO

LABORATOIRE THERAMEX -

MONAKO

REGJ.

294/14.05.20092.27

1163

COLPOTROPHINEGynaecological

cream x 1g/100gPROMESTRIENE

Box x 1 tube x

15g

LABORATOIRE

THERAMEX - MONAKO

LABORATOIRE THERAMEX -

MONAKO

REGJ.

294/14.05.20092.44

1164

COLPOSEPTINE

Gynaecological

tablets x (200mg +

10mg)

CHLORQUINALDOL +

PROMESTRIENEBox x 18

LABORATOIRE

THERAMEX - MONAKO (e

regjistruar ne Malte)

LABORATOIRE THERAMEX -

MONAKO

REGJ.

309/17.05.2010

3.89

Page 153

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154

1165

LUTENYLScored tablets x

5mgNOMEGESTROL ACETATE Box x 10

LABORATOIRE

THERAMEX - MONAKO (e

regjistruar ne Malte, Itali)

LABORATOIRE THERAMEX -

MONAKO

REGJ.

526/01.10.2010

3.37

1166

ESTREVA Gel x 0.1g/100g

ANHYDROUS ESTRADIOL

(as ESTRADIOL

HEMIHYDRATE x

0.10325g/100g. The pump

delivers unit doses of 0.5g of

gel, corresponding to 0.5mg

of ESTRADIOL.)

Box x pump

dosage bottle x

50g

LABORATOIRE

THERAMEX - MONAKO

(regjistruar ne Malte dhe

Irlande)

LABORATOIRE THERAMEX -

MONAKO

REGJ.

156/20.04.2011

3.79

1167

PAN -

CEFTRIAXONE

1G/3.5ML

Powder and

solvent for solution

for injection (I.M.) x

1g/3.5ml

CEFTRIAXONE (AS

CEFTRIAXONE SODIUM)

Box x (1 glass

vial + 1 ampoule

x 3.5ml solvent

(with 1%

Lidocaine

hydrochloride in

water for

injection)

PANPHARMA - FRANCE PANPHARMA - FRANCERIREGJ.

676/31.12.2010

3.8

1168

DEXAMETHASON-

ROTEXMEDICA

Solution for

injection x 5mg/ml

DEXAMETHASONE

SODIUM PHOSPHATE

Box x 10

ampoules x 1ml

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

RIREGJ.

417/10.09.2012

2

1169

DICLOFENAC

SODIUM

Solution for

injection x 25mg/mlDICLOFENAC SODIUM

Box x 10

ampoules x 3ml

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

RIREGJ.

602/05.11.2010

1.89

1170

HYOSCINE

BUTYLBROMIDE

INJECTION BP

20MG

Solution for I.M./I.V.

injection x

20mg/1ml

HYOSCINE

BUTYLBROMIDE

Box x 10

ampoules x 1ml

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

RIREGJ.

647/10.12.2010

3.05

1171

OXYTOCIN

INJECTION BP 10

UNITS

Solution for I.M./I.V.

injection x 10

I.U./1ml

OXYTOCINBox x 10

ampoules x 1ml

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

RIREGJ.

647/10.12.2010

1.95

Page 154

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155

1172

PAN -

CEFAZOLINE 1G

Powder for solution

for injection x

1g/vial

CEFAZOLIN SODIUM

EQUIVALENT TO

CEFAZOLIN BASE x 1g/vial

Box x 1 vial

powder + 1

ampoule solvent

PANPHARMA - FRANCEPANPHARMA - FRANCE;

BIOPHARMA S.R.L. - ITALI

RIREGJ.

583/29.10.2010

1.15

1173

PIPERACILLIN/TA

ZOBACTAM

PANPHARMA

Powder for solution

for infusion x (4g +

500mg)/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM) +

TAZOBACTAM (as

TAZOBACTAM SODIUM)

Box x 10 vials

(for hospital use

only)

PANPHARMA - FRANCE PANPHARMA - FRANCEREGJ.

239/20.04.2010

100

1174

PAN-PENICILLIN

G SODIUM

Powder for I.V.

injection x 1000000

IU/vial

BENZYLPENICILLIN

SODIUMBox x 25 vials PANPHARMA - FRANCE PANPHARMA - FRANCE

RIREGJ.

582/29.10.201012.5

1175

PAN -

CEFUROXIME

Powder for solution

for injection

(I.M/I.V.) x

750mg/vial

CEFUROXIME (AS

CEFUROXIME SODIUM x

789mg/vial)

Box x 10 glass

vials (for

hospital use)

PANPHARMA - FRANCE PANPHARMA - FRANCERIREGJ.

581/29.10.2010

11

1176

THIOPENTAL

INJECTION BP 1G

Powder for

injection x 1gTHIOPENTAL SODIUM

Box x 50 vials

(only for hospital

use)

ROTEXMEDICA GMBH

ARZNEIMITTELWERK -

GJERMANI

LABORATOIRES

PANPHARMA - FRANCE

RIREGJ.

516/24.09.2010

69

1177

CEFTRIAXONE-

AFT

Powder for solution

for injection x

1g/vial

CEFTRIAXONE (as

SODIUM)Box x 1 vial

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"QILU PHARMACEUTICAL

CO.LTD" KINE

Regj.

359/28.05.2013

2.9

1178

CEFEPIME-AFT

Powder and

solvent for solution

for injection x

1g/vial

CEFEPIME (as CEFEPIME

DIHYDROCHLORIDE

MONOHYDRATE )

Box x 1 vial

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"QILU ANTIBIOTICS

PHARMACEUTICAL CO.LTD"

KINE; "QILU

PHARMACEUTICAL CO.LTD"

KINE

Regj.422/11.07.2013

7.5

1179

COCO-SCALPOintment x (2% +

4% + 12%) w/e

SALICYLIC ACID + SULFUR

PRECIPITATED + COAL

TAR SOLUTION

Box x 1 tube x

40g

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"HOE PHARMACEUTICALS

SDN BHD" MALAJZIRegj.422/11.07.2013

3.25

1180

MAXICLEAR

COLD & FLU

RELIEF

Tablets x (5mg +

500mg)

PHENYLEPHRINE

HYDROCHLORIDE +

PARACETAMOL

Box x 30

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"SIGMA LABORATORIES

LTD" INDIRegj.422/11.07.2013

2.25

1181

MAXICLEAR

SINUS & PAIN

RELIEF

Tablets x (5mg +

500mg)

PHENYLEPHRINE

HYDROCHLORIDE +

PARACETAMOL

Box x 30

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"SIGMA LABORATORIES

LTD" INDIRegj.422/11.07.2013

2.25

Page 155

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156

1182

MAXICLEAR

SINUS RELIEFTablets x 10mg

PHENYLEPHRINE

HYDROCHLORIDEBox x 30

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"SIGMA LABORATORIES

LTD" INDIRegj.422/11.07.2013

2.25

1183

CEFAZOLIN-AFT

Powder for for

solution for

injection x 1g/vial

CEFAZOLINE (as

CEFAZOLINE SODIUM x

1.048g/vial)

Box x 5 vials

"AFT

PHARMACEUTICALS PTY

LTD" AUSTRALI

"QILU PHARMACEUTICALS

CO.LTD" KINE

Regj. 390/

17.06.2013

5

1184

OMEPRAZOL

G.E.S

Powder for solution

for infusion x

40mg/vial

OMEPRAZOLE

Box x 50 vials

(for hospital

use)

G.E.S. GENERICOS

ESPANOLES

LABORATORIOS SA -

SPANJE

ALFA WASSERMAN SPA -

ITALI; BIOMENDI SA -

SPANJE; SOFARINEX -

PORTUGALI

REGJ.

452/31.10.2011

1000

1185

PARACETAMOL

G.E.S.

Solution for

infusion x 10mg/mlPARACETAMOL

Box x 12

aluminum bags

(for hospital

use)

G.E.S GENERICOS

ESPANOLES

LABORATORIOS SA -

SPANJE

BIOMENDI SA - SPANJE, S.C

INFORMED FLUIDS SRL -

RUMANI (APL: BIOMENDI SA -

SPANJE)

REGJ.

422/12.09.2012

120

1186

LOBEN PLUS

Film-coated tablets

x (100mg +

12.5mg)

LOSARTAN POTASSIUM+

HYDROCHLOROTHIAZIDEBox x 28

"BENNETT

PHARMACEUTICALS

S.A." GREQI

"RAFARM S.A." GREQIRegj.

384/ 17.06.2013

5.2

1187

LOBEN PLUSFilm-coated tablets

x (100mg + 25mg)

LOSARTAN POTASSIUM+

HYDROCHLOROTHIAZIDEBox x 28

"BENNETT

PHARMACEUTICALS

S.A." GREQI

"RAFARM S.A." GREQIRegj.

384/ 17.06.2013

5.5

1188

CEFGRAM

Powder for oral

suspension x

250mg/5ml

CEFPROZIL (as

CEFPROZIL

MONOHYDRATE x

52.31mg/unite dose)

Box x 1 plastic

bottle x 100ml

"BENNETT

PHARMACEUTICALS

S.A." GREQI

"AUROBINDO PHARMA

LIMITED, UNIT-VI" INDIRegj.422/11.07.2013

7.8

1189

CEFGRAMFilm coated tablets

x 500mg

CEFPROZIL (as

CEFPROZIL

MONOHYDRATE x

523.1mg)

Box x 12

"BENNETT

PHARMACEUTICALS

S.A." GREQI

"HELP S.A." GREQIRegj.

384/ 17.06.2013

7.9

1190

ZULGAR Tablets x 70mg

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE X 91.37mg)

Box x 4

"MEDICAL

PHARMAQUALITY

PHARMACEUTICAL SA"

GREQI

"GENEPHARM SA" GREQIRegj.

384/ 17.06.2013

12.5

1191

GLEPARK Tablets x 0.18mg

PRAMIPEXOLE (as

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE x 0.25mg)

Box x 30

"BENNETT

PHARMACEUTICALS

S.A." GREQI

"GLENMARK GENERICS

LIMITED" INDI

Regj.

384/ 17.06.2013

10.5

Page 156

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157

1192

GLEPARK Tablets x 0.35mg

PRAMIPEXOLE (as

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE x 0.5mg)

Box x 30

"BENNETT

PHARMACEUTICALS

S.A." GREQI

"GLENMARK GENERICS

LIMITED" INDI

Regj.

384/ 17.06.2013

13.9

1193

ALESTOPORSoft capsules x

0.25mcgALFACALCIDOL Box x 30

BENNETT

PHARMACEUTICALS SA -

GREQI

ALCALA FARMA SL -

SPANJE

REGJ.

581/16.11.20124.3

1194

TALOSINFilm-coated tablets

x 20mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x

24.990mg)

Box x 28

BENNETT

PHARMACEUTICALS SA -

GREQI

ANFARM HELLAS SA -

GREQI, RAFARM SA - GREQI

REGJ.

581/16.11.2012

7.7

1195

GLIPERIN Tablets x 2mg GLIMEPIRIDE Box x 30

BENNETT

PHARMACEUTICALS SA -

GREQI

RAFARM SA - GREQIREGJ.

581/16.11.20125.4

1196

CARNIBENOral solution x

1g/10mlLEVOCARNITINE

Box x 10 vials x

10ml

BENNETT

PHARMACEUTICALS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ.

581/16.11.20125.4

1197

HEMOMYCINFilm-coated tablets

x 500mg

AZITHROMYCIN (AS

AZITHROMYCIN

DIHYDRATE)

Box x 3 HEMOFARM A.D. - SERBIHEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

584/29.10.20105

1198

ACICLOSTAD

GEGEN

LIPPENHERPES

Cream x 50mg/g ACICLOVIRBox x 1 tube x

2g

STADA GMBH -

GJERMANI

STADA GMBH - GJERMANI;

STADA ARZNEIMITTEL AG -

GJERMANI (APL: STADA

ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

269/28.04.2010

2.16

1199

CEFUROXIM

STADATablets x 500mg

CEFUROXIME (AS

CEFUROXIME AXETIL x

601.44 mg)

Box x 12STADAPHARM GMBH -

GJERMANI

RANBAXY LABORATORIES

LTD - INDI, STADA

ARZNEIMITTEL AG -

GJERMANI

RIREGJ. 433/2 Dt.

28.09.2012

8.585

1200

PAROXETIN

STADA

Film coated tablets

x 20 mg

PAROXETINE (as

PAROXETINE

HYDROCHLORIDE)

Box x 20;STADAPHARM GMBH -

GJERMANI

"HEMOFARM AD" SERBI;

dhe me APLIKANT per

çertifikate : "STADA

ARZNEIMITTEL AG"

GJERMANI

Riregj.

476/09.09.2013

5.5

Page 157

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158

1201

ACESTADEffervescent

tablets x 200mgACETYLCYSTEINE Box x 20

STADAPHARM GMBH -

GJERMANI

MERCKLE GMBH -

GJERMANI; STADA

ARZNEIMITTEL AG -

GJERMANI (APL: STADA

ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

409/07.10.2011

2

1202

ACESTADEffervescent

tablets x 600mgACETYLCYSTEINE Box x 10

STADAPHARM GMBH -

GJERMANI

MERCKLE GMBH -

GJERMANI; STADA

ARZNEIMITTEL AG -

GJERMANI (APL: STADA

ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

409/07.10.2011

2.5

1203

TRAMADOL

Solution for

injection x

100mg/2ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 2mlHEMOFARM AD - SERBI HEMOFARM AD - SERBI

RIREGJ.

380/13.08.20121.45

1204TRAMADOL

Hard capsules x

50 mg

TRAMADOL

HYDROCHLORIDEBox x 20 HEMOFARM AD - SERBI HEMOFARM AD - SERBI

RIREGJ. 433/2 Dt.

28.09.2012 1.4

1205

TRAMADOL

STADA

Suppositories x

100mg

TRAMADOL

HYDROCHLORIDEBox x 10

STADA PHARM GMBH -

GJERMANI

STADA PHARM GMBH -

GJERMANI; AMCAPHARM

GMBH - GJERMANI (APL:

STADA ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

300/12.05.2010

2.3

1206

TRAMADOL

STADA

Oral drops solution

x 100mg/ml

TRAMADOL

HYDROCHLORIDE

Box x 1 flacon x

10ml

STADAPHARM GMBH -

GJERMANI

STADAPHARM GMBH -

GJERMANI; STADA

ARZNEIMITTEL AG -

GJERMANI (APL: STADA

ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

455/06.08.2010

2.35

1207LEMOD Tablets x 4mg METHYLPREDNISOLONE Box x 20 HEMOFARM A.D. - SERBI HEMOFARM A.D. - SERBI

RIREGJ.

582/29.10.2010 1.05

1208

LEMOD-SOLU

Powder and

solvent for solution

for

injection/infusion x

40mg/vial

METHYLPREDNISOLONE

(IN THE FORM OF

METHYLPREDNISOLONE

SODIUM SUCCINATE,

CORRESP. TO 57.7mg/vial

METHYLPREDNISOLONE

HEMISUCCINATE)

Box x (15 vials

of powder + 15

ampoules of

solvent x 1ml)

(for hospital

use)

HEMOFARM A.D. - SERBI HEMOFARM A.D. - SERBIRIREGJ.

76/01.03.2011

14.5

Page 158

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159

1209

LEMOD SOLU

Powder and

solvent for solution

for

injection/infusion x

20 mg/ml

METHYLPREDNISOLONE

(AS

METHYLPREDNISOLONE

SODIUM SUCCINATE)

Box x 15 vials +

15 ampoules

(1ml)

HEMOFARM AD - SERBI HEMOFARM AD - SERBIRIREGJ. 433/2 Dt.

28.09.2012

12.5

1210

MAROCEN Eye drops solution

x 0.3%

CIPROFLOXACIN (as

CIPROFLOXACIN

HYDROCHLORIDE x

3.5mg/ml)

Box x 1 flacon x

5mlHEMOFARM AD - SERBI HEMOMONT DOO - MALI I ZI

REGJ.

297/25.06.2012

1.55

1211

NEODEKSACIN

Eye drops solution

x (3.5mg/ml +

1mg/ml)

NEOMYCIN (as NEOMYCIN

SULPHATE x 5mg/ml) +

DEXAMETHASONE

PHOSPHATE (as

DEXAMETHASONE

SODIUM PHOSPHATE x

1.1mg/ml)

Box x 1 flacon x

10mlHEMOFARM AD - SERBI HEMOMONT DOO - MALI I ZI

REGJ.

297/25.06.2012

1.05

1212

OTOL H

Ear drops, solution

x (0.1mg + 1mg +

10mg)/g

TYROTHRICIN +

PREDNISOLONE +

TETRACAINE

HYDROCHLORIDE

Box x 1 flacon x

10gHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

645/10.12.2010

1.655

1213

RINASEKSyrup x (1.25mg +

30mg)/5ml

TRIPROLIDINE

HYDROCHLORIDE +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 1 bottle x

100mlHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

582/29.10.2010

3.525

1214

RINASEKTablets x (2.5mg +

60mg)

TRIPROLIDINE

HYDROCHLORIDE +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 10 HEMOFARM A.D. - SERBIHEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

582/29.10.2010

3.05

1215

GRIPPOSTAD

HOT DRINK

Powder for oral

solution x

600mg/5g sachet

PARACETAMOLBox x 10

sachets

STADA GMBH -

GJERMANI

ALLPHAMED PHARBIL

ARZNEIMITTEL GMBH -

GJERMANI; STADA

ARZEIMITTEL AG -

GJERMANI (APL: STADA

ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

455/06.08.2010

2.58

Page 159

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160

1216

GRIPPOSTAD C

Capsules x (200mg

+ 150mg + 25mg +

2.5mg)

PARACETAMOL +

ASCORBIC ACID +

CAFFEINE +

CHLORPHENAMINE

HYDROGENMALEATE

Box x 20STADA GMBH -

GJERMANI

STADA GMBH - GJERMANI;

STADA ARZNEIMITTEL AG -

GJERMANI (APL: STADA

ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

455/06.08.2010

2.5

1217RAPTEN DUO Tablets x 75 mg DICLOFENAC SODIUM Box x 30 HEMOFARM AD - SERBI HEMOFARM AD - SERBI

REGJ.

684/15.12.2008 4.2

1218

PANLAX

Gastro-resistant

coated tablets x

5mg

BISACODYL Box x 30 HEMOFARM A.D. - SERBI HEMOFARM A.D. - SERBIRIREGJ.

645/10.12.20100.73

1219

PANLAXSuppositories x

10mgBISACODYL Box x 6 HEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

645/10.12.20101.05

1220

HEPATHROMBIN Gel x 300 I.U./g HEPARIN SODIUM Box x 1 tube x

40gHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

516/24.09.20102.2

1221

HEPATHROMBIN Gel x 500 I.U./g HEPARIN SODIUM Box x 1 tube x

40gHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

516/24.09.20102.9

1222

HEPATHROMBIN Cream x 300 I.U./g HEPARIN SODIUM Box x 1 tube x

40gHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

584/29.10.20102.2

1223

HEPATHROMBIN Cream x 500 I.U./g HEPARIN SODIUM Box x 1 tube x

40gHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

584/29.10.20102.9

1224

HEPATHROMBIN

H

Ointment x (65 I.U.

+ 2.233mg +

30mg)/g

HEPARIN SODIUM +

PREDNISOLONE ACETATE

+ POLIDOCANOL

(MACROGOL LAURYL

ETHER)

Box x 1 tube x

20gHEMOFARM A.D. - SERBI

HEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

516/24.09.2010

1.5

1225

HEPATHROMBIN

H

Suppositories x

(120 I.U. +

1.675mg + 30mg)

HEPARIN SODIUM +

PREDNISOLONE ACETATE

+ POLIDOCANOL

(MACROGOL LAURYL

ETHER)

Box x 10 HEMOFARM A.D. - SERBIHEMOFARM KONCERN

ZORKA PHARMA AD - SERBI

RIREGJ.

516/24.09.2010

1.785

Page 160

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161

1226

GLUCOSI

INFUNDIBILE

Solution for

infusion x 5%

(25g/500ml)

GLUCOSE ANHYDROUS

(AS GLUCOSE

MONOHYDRATE X

27.5g/500ml)

Plastic bottle x

500 mlHEMOFARM AD - SERBI HEMOFARM AD - SERBI

RIREGJ. 433/2 Dt.

28.09.2012

0.575

1227

NATRII CHLORIDI

INFUNDIBILE

Solution for

infusion x 0.9%

(4.5g/500ml)

SODIUM CHLORIDE Plastic bottle x

500 mlHEMOFARM AD - SERBI HEMOFARM AD - SERBI

RIREGJ. 433/2 Dt.

28.09.20120.535

1228

LEMOD-SOLU

Powder and

solvent for solution

for

injection/infusion x

500mg/vial

METHYLPREDNISOLONE

SODIUM SUCCINATE

CORRESPONDING TO

633.64mg/vial

METHYLPREDNISOLONE

HEMISUCCINATE

Box x (1 vial + 1

ampoule with

solvent x 7.8ml)

HEMOFARM A.D. - SERBI HEMOFARM A.D. - SERBIRIREGJ.

584/29.10.2010

7.525

1229

LEMOD-DEPOSuspension for

injection x 40mg/ml

METHYLPREDNISOLONE

ACETATE

Box x 10 vials x

1mlHEMOFARM A.D. - SERBI HEMOFARM A.D. - SERBI

RIREGJ.

584/29.10.201010.455

1230

PROSTATA

STADA

Film-coated tablets

x 125mg

DRY EXTRACT OF

STINGING NETTLE ROOT

(7-9:1) + [EXTRACTANT:

ETHANOL 60% (v/v)]

Box x 100 STADAPHARM GMBH -

GJERMANI

ROTTENDORF PHARMA

GMBH - GJERMANI (APL:

STADA ARZNEIMITTEL AG -

GJERMANI)

RIREGJ.

455/06.08.2010

5.525

1231

FEBRICET Syrup x 120mg/5ml PARACETAMOLBox x 1 glass

bottle x 100mlHEMOFARM AD - SERBI HEMOFARM AD - SERBI

REGJ.

140/19.03.20131.2

1232

ZENIXSolution for

infusion x 2mg/mlLINEZOLID

Box x 1 bottle x

300mlHEMOFARM AD - SERBI HEMODONT D.O.O - MAL I ZI

REGJ.

140/19.03.201327

1233ZENIX

Film-coated tablets

x 600mgLINEZOLID Box x 10 HEMOFARM AD - SERBI HEMOFARM AD - SERBI

REGJ.

596/26.11.2012 310

1234

PANCILLIN

Powder for

suspension for

injection x (200 000

IU + 600 000

IU)/vial

BENZYLPENICILLIN

SODIUM + PROCAINE

BENZYLPENICILLIN

Box x 50 (for

hospital use)"HEMOFARM AD" SERBI "HEMOFARM AD" SERBI

Regj.

359/28.05.2013

24

Page 161

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162

1235

PANKLAV 2X

Powder for oral

suspension x

(400+57)mg/5ml

AMOXICILLIN (as

AMOXICILLIN

TRIHYDRATE) +

CLAVULANIC ACID (as

POTASSIUM

CLAVULANATE, diluted with

silicon dioxide (1:1))

Box x 1 glass

bottle x 140mlHEMOFARM AD - SERBI HEMOFARM AD - SERBI

REGJ.

604/27.11.2012

6

1236

HEMOMYCIN

Powder for solution

for infusion x

500mg/vial

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE)

Box x 1 vial HEMOFARM AD - SERBI HEMOFARM AD - SERBIREGJ.

596/26.11.2012

6.5

1237

LEVOFLOXACIN

STADA

Film coated tablets

x 500mg

LEVOFLOXACIN (as

LEVOFLOXACIN 0.5 H2O x

512.46mg)

Box x 10"STADAPHARM GMBH"

GJERMANI

"LABORATORIOS

MEDICAMENTOS

INTERNACIONALES S.A."

SPANJE

Regj.475/09.09.2013

7.155

1238

ZOBOXFilm-coated tablets

x 2.5mg

CILAZAPRIL (as

CILAZAPRIL

MONOHYDRATE x 2.61mg)

Box x 30 "HEMOFARM AD" SERBI "HEMOFARM AD" SERBI Regj.475/09.09.2013

3.525

1239

ZOBOXFilm-coated tablets

x 5mg

CILAZAPRIL (as

CILAZAPRIL

MONOHYDRATE x 5.21mg)

Box x 30 "HEMOFARM AD" SERBI "HEMOFARM AD" SERBI Regj.475/09.09.2013

5.525

1240

SINEDOLGel x (500IU +

150mg + 25mg)/g

HEPARIN SODIUM +

DIMETHYL SULFOXIDE +

DEXPANTHENOL

Box x 1 tube x

40g"HEMOFARM AD" SERBI "HEMOFARM AD" SERBI Regj.475/09.09.2013

2.65

1241

IRBENIDA PLUS

Film-coated tablets

x (150mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 30 "HEMOFARM AD" SERBI "HEMOFARM AD" SERBI Regj.475/09.09.2013

5.335

1242

IRBENIDA PLUS

Film-coated tablets

x (300mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 30 "HEMOFARM AD" SERBI "HEMOFARM AD" SERBI Regj.475/09.09.2013

7.865

1243

CALCI-10

Nasal spray,

solution x 100

IU/dose

CALCITONIN, SALMON

(1111.11 IU/1ML)

Box x 1 glass

bottle x 4ml (28

doses) - dose

meter pump

PHARMATHEN HELLAS

SA - GREQI

PHARMANEL

PHARMACEUTICALS SA -

GREQI

REGJ.

646/10.12.2010

8.2

Page 162

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163

1244

DEPREVIX

Prolonged-release

hard capsules x

75mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE x

84.86mg)

Box x 28PHARMATHEN HELLAS

SA - GREQI

PHARMATHEN SA - GREQI;

BOEHRINGER INGELHEIM

ELLAS SA - GREQI;

PHARMATHEN

INTERNATIONAL SA - GREQI

REGJ.

646/10.12.2010

9.8

1245

DEPREVIX

Prolonged-release

hard capsules x

75mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE x

84.86mg)

Box x 30PHARMATHEN HELLAS

SA - GREQI

PHARMATHEN SA - GREQI;

BOEHRINGER INGELHEIM

ELLAS SA - GREQI;

PHARMATHEN

INTERNATIONAL SA - GREQI

REGJ.

646/10.12.2010

10.5

1246

ROWATINEX

Gastro-resistant

soft capsules x

(24.8mg + 6.2mg +

15mg + 3mg + 4mg

+ 10mg + 4mg)

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

FENCHONE + BORNEOL +

ANETHOL

Box x 30

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDERegj.422/11.07.2013

5.5

1247

ROWATINEX

Gastro-resistant

soft capsules x

(24.8mg + 6.2mg +

15mg + 3mg + 4mg

+ 10mg + 4mg)

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

FENCHONE + BORNEOL +

ANETHOL

Box x 50

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDERegj.422/11.07.2013

9

1248

ROWATINEX

Oral drops, solution

x (24.8mg + 6.2mg

+ 15mg + 3mg +

4mg + 10mg +

4mg)/100g

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

FENCHONE + BORNEOL +

ANETHOL

Box x 1 glass

droper vial x

20ml

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDERegj.422/11.07.2013

10

1249

ROWACHOL

Gastro-resistant

soft capsules x

(13.6mg + 3.4mg +

5mg + 2mg + 6mg

+ 32mg + 5mg)

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

MENTHONE +

LEVOMENTHOL +

BORNEOL

Box x 30;

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDE

Regj.

359/28.05.2013

5.5

Page 163

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164

1250

ROWACHOL

Gastro-resistant

soft capsules x

(13.6mg + 3.4mg +

5mg + 2mg + 6mg

+ 32mg + 5mg)

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

MENTHONE +

LEVOMENTHOL +

BORNEOL

Box x 50

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDE

Regj.

359/28.05.2013

9

1251

TROPEXEar drops solution

x 5% (w/v) PHENAZONE

Box x 1 glass

bottle with a

dropper x 10ml

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDE

Regj.

359/28.05.2013

5

1252

ROWACHOL

Oral drops, solution

x (13.6mg + 3.4mg

+ 5mg + 2mg +

6mg + 32mg +

5mg) / 100g

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

MENTHONE + MENTOL +

BORNEOL

Box x 1 glass

droper vial x

20ml

"ROWA

PHARMACEUTICALS

LTD" IRLANDE

"ROWA PHARMACEUTICALS

LTD" IRLANDERegj.422/11.07.2013

10

Page 164

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165

1253

CONCERTAProlonged release

tablets x 18mg

METHYLPHENIDATE

HYDROCHLORIDE

Plastic bottle x

30

JANSSEN-CILAG NV -

BELGJIKË

ALZA CORPORATION -

SHBA; MCGREGOR CORY

LIMITED - MBRETERI E

BASHKUAR; ORTHO-MC

NEIL JANSSEN

PHARMACEUTICAL INC.

GLOBAL PHARMACEUTICAL

SUPPLY GROUP - SHBA;

JANSSEN-CILAG

MANUFACTURING, L.L.C. -

PORTO RIKO; ANDERSON

PACKAGING INC. - SHBA;

ALZA IRELAND LTD -

IRLANDE; JANSSEN

PHARMACEUTICA N.V. -

BELGJIKË (APLIKANT:

JANSSEN PHARMACEUTICA

NV - BELGJIKË)

RIREGJ.

647/10.12.2010

31.16

Page 165

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166

1254

CONCERTAProlonged release

tablets x 36mg

METHYLPHENIDATE

HYDROCHLORIDE

Plastic bottle x

30

JANSSEN-CILAG NV -

BELGJIKË

ALZA CORPORATION -

SHBA; MCGREGOR CORY

LIMITED - MBRETERI E

BASHKUAR; ORTHO-MC

NEIL JANSSEN

PHARMACEUTICAL INC.

GLOBAL PHARMACEUTICAL

SUPPLY GROUP - SHBA;

JANSSEN-CILAG

MANUFACTURING, L.L.C. -

PORTO RIKO; ANDERSON

PACKAGING INC. - SHBA;

ALZA IRELAND LTD -

IRLANDE; JANSSEN

PHARMACEUTICA N.V. -

BELGJIKË (APLIKANT:

JANSSEN PHARMACEUTICA

NV - BELGJIKË)

RIREGJ.

647/10.12.2010

39.43

1255

DAKTARIN Oral gel x 20mg MICONAZOLE Box x 1 tube x

40g

JANSSEN-CILAG NV -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKE (APL:

JANSSEN PHARMACEUTICA

NV - BELGJIKE)

RIREGJ

62/06.02.2013

4

1256

DAKTARIN Cream x 20mg/g MICONAZOLE NITRATEBox x 1 tube x

30g

JANSSEN-CILAG N.V. -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKË (APL:

JANSSEN PHARMACEUTICA

NV - BELGJIKË)

RIREGJ.

71/09.02.2010

3.5

Page 166

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167

1257

DAKTACORTCream x (20mg +

10mg)/g

MICONAZOLE NITRATE +

HYDROCORTISONE

Box x 1 tube x

15g

JOHNSON & JOHNSON

CONSUMER NV/SA -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKE (APL:

JANSSEN PHARMACEUTICA

NV - BELGJIKE)

RIREGJ

62/06.02.2013

2.5

1258

DUROGESICTransdermal

patches x 25µg/h

FENTANYL (x

4.2mg/transdermal patch)

Box x 5

transdermal

patches

JANSSEN-CILAG NV -

BELGJIKE

JANSSEN PHARMACEUTICA

N.V - BELGJIKE (APL:

JANSSEN PHARMACEUTICA

N.V - BELGJIKE)

RIREGJ.

167/19.04.2012

11.7

1259

DUROGESICTransdermal

patches x 50µg/h

FENTANYL (x

8.4mg/transdermal patch)

Box x 5

transdermal

patches

JANSSEN-CILAG NV -

BELGJIKE

JANSSEN PHARMACEUTICA

N.V - BELGJIKE (APL:

JANSSEN PHARMACEUTICA

N.V - BELGJIKE)

RIREGJ.

167/19.04.2012

22.5

1260

EPREX

Solution for

injection x 1000

IU/0.5ml

(8.4µg/0.5ml)

EPOETINUM ALFA

(Recombinant Human

Erythropoietin)

Box x 6 pre-

filled syringes x

0.5ml

JANSSEN-CILAG AG -

ZVICER

CILAG AG - ZVICER (APL.

:CILAG AG - ZVICER)

RIREGJ

62/06.02.2013

64.8

1261

EPREX

Solution for

injection x 3000

IU/0.3ml

(25.2µg/0.3ml)

EPOETINUM ALFA

(Recombinant Human

Erythropoietin)

Box x 6 pre-

filled syringes x

0.3ml

JANSSEN-CILAG AG -

ZVICER

CILAG AG - ZVICER (APL.

:CILAG AG - ZVICER)

RIREGJ

62/06.02.2013

123.83

1262

EPREX

Solution for

injection x 4000

IU/0.4ml

(33.6µg/0.4ml)

EPOETINUM ALFA

(Recombinant Human

Erythropoietin)

Box x 6 pre-

filled syringes x

0.4ml

JANSSEN-CILAG AG -

ZVICER

CILAG AG - ZVICER (APL.

:CILAG AG - ZVICER)

RIREGJ

62/06.02.2013

167.79

1263

EPREX

Solution for

injection x 10000

IU/0.5ml

(84.0µg/ml)

EPOETINUM ALFA

(Recombinant Human

Erythropoietin)

Box x 6 pre-

filled syringes x

1ml

JANSSEN-CILAG AG -

ZVICER

CILAG AG - ZVICER (APL.

:CILAG AG - ZVICER)

RIREGJ

62/06.02.2013

354.36

1264

GYNO-PEVARYLVaginal cream x

1g/100gECONAZOLE NITRATE

Box x 1 tube x

30g

JANSSEN-CILAG LTD,

MBRETERI E BASHKUAR

JANSSEN PHARMACEUTICA

N.V" BELGJIKE (APL: CILAG

AG - ZVICER)

RIREGJ.

366/23.09.2011;

Variacion 595/1,

16.04.2013 1.44

Page 167

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168

1265

GYNO - PEVARYLVaginal ovule x

50mgECONAZOLE NITRATE Box x 15 ovules

JANSSEN-CILAG AG -

ZVICER

XIAN-JANSSEN

PHARMACEUTICAL CO. LTD -

KINE

RIREGJ.

372/27.09.20115.5

1266

FENTANYL-

JANSSEN

Solution for

injection x

0.5mg/10ml

FENTANYL (as FENTANYL

CITRATE x 0.785mg/10ml)

Box x 5

ampoules x

10ml

JANSSEN-CILAG NV -

BELGJIKE

GLAXOSMITHKLINE

MANUFACTURING SPA -

ITALI (APL: JANSSEN

PHARMACEUTICA N.V -

BELGJIKE)

RIREGJ.

366/23.09.2011

3.5

1267

INVEGA

Prolonged -

release tablets x

3mg

PALIPERIDONE Box x 28

JANSSEN - CILAG

INTERNATIONAL NV -

BELGJIKE

JANSSEN CILAG

MANUFACTURING LLC -

PORTO RIKO; ALZA

CORPORATION - SHBA;

JANSSEN - CILAG SPA -

ITALI (APL. PER

CERTIFIKATE: CILAG AG -

ZVICER)

RIREGJ.

334/20.05.2013

79.73

1268

INVEGA

Prolonged -

release tablets x

6mg

PALIPERIDONE Box x 28

JANSSEN - CILAG

INTERNATIONAL NV -

BELGJIKE

JANSSEN CILAG

MANUFACTURING LLC -

PORTO RIKO; ALZA

CORPORATION - SHBA;

JANSSEN - CILAG SPA -

ITALI (APL. PER

CERTIFIKATE: CILAG AG -

ZVICER)

RIREGJ.

334/20.05.2013

83.2

1269

INVEGA

Prolonged -

release tablets x

9mg

PALIPERIDONE Box x 28

JANSSEN - CILAG

INTERNATIONAL NV -

BELGJIKE

JANSSEN CILAG

MANUFACTURING LLC -

PORTO RIKO; ALZA

CORPORATION - SHBA;

JANSSEN - CILAG SPA -

ITALI (APL. PER

CERTIFIKATE: CILAG AG -

ZVICER)

RIREGJ.

334/20.05.2013

87.33

1270

INVEGA

SUSTENNA

prolonged release

suspension for

injection x

75mg/pre-filled

syringe

PALIPERIDONE (as

PALIPERIDONE

PALMITATE)

Box x 1 pre-

filled syringe x

0.75ml and 2

needles

JANSSEN-CILAG

INTERNATIONAL NV -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKE (APL: CILAG

AG - ZVICER)

REGJ. 61/06.02.2013

263.71

Page 168

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169

1271

INVEGA

SUSTENNA

prolonged release

suspension for

injection x

100mg/pre-filled

syringe

PALIPERIDONE (as

PALIPERIDONE

PALMITATE)

Box x 1 pre-

filled syringe x

1ml and 2

needles

JANSSEN-CILAG

INTERNATIONAL NV -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKE (APL: CILAG

AG - ZVICER)

REGJ. 61/06.02.2013

329.64

1272

INVEGA

SUSTENNA

prolonged release

suspension for

injection x

150mg/pre-filled

syringe

PALIPERIDONE (as

PALIPERIDONE

PALMITATE)

Box x 1 pre-

filled syringe x

1.5ml and 2

needles

JANSSEN-CILAG

INTERNATIONAL NV -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKE (APL: CILAG

AG - ZVICER)

REGJ. 61/06.02.2013

412.04

1273

MOTILIUM adultsSuppositories x

60mgDOMPERIDONE Box x 6

JOHNSON & JOHNSON

CONSUMER NV -

BELGJIKE

LUSOMEDICAMENTA

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGALI, CILAG AG -

ZVICER, JANSSEN

PHARMACEUTICA N.V -

BELGJIKE (APL: JANSSEN

PHARMACEUTICA NV -

BELGJIKE)

REGJ.

297/25.06.2012

2.07

1274

MOTILIUMFilm-coated tablets

x 10mgDOMPERIDONE Box x 60

JOHNSON & JOHNSON

LDA - PORTUGALI

LUSOMEDICAMENTA

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGALI; JANSSEN

PHARMACEUTICA N.V (FAB.

BEERSE) - BELGJIKE (APL:

LUSOMEDICAMENTA

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGAL)

RIREGJ

62/06.02.2013

3.48

1275

NIZORAL Shampoo x 20mg/gKETOCONAZOLE x (20mg +

1mg overage)

Box x 1 plastic

bottle x 60ml

JOHNSON & JOHNSON

CONSUMER NV -

BELGJIKË

JANSSEN-PHARMACEUTICA

N.V. - BELGJIKË (APLIKANT:

JANSSEN-PHARMACEUTICA

N.V. - BELGJIKË)

RIREGJ.

35/25.01.2011

4.2

Page 169

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170

1276

NIZORAL Cream x 20mg/g KETOCONAZOLE Box x 1 tube x

30g

JOHNSON & JOHNSON

CONSUMER NV -

BELGJIKË

JANSSEN-PHARMACEUTICA

N.V. - BELGJIKË (APL:

JANSSEN-PHARMACEUTICA

N.V. - BELGJIKË)

RIREGJ.

96/16.03.2011

5.4

1277

PARIETGastro-resistant

tablets x 20mgRABEPRAZOLE SODIUM Box x 14

JANSSEN-CILAG NV -

BELGJIKE

JANSEN PHARMACEUTICA

NV - BELGJIKE; CILAG AG -

ZVICER; THE BOOTS

COMPANY - MBRETERI E

BASHKUAR; PTG

LOHNVERPACKUNG GMBH -

GJERMANI; KRONANS

DROGHANDEL AB - SUEDI;

PHARMAPACK (UK) LIMITED

- MBRETERI E BASHKUAR

(APL. : JANSSEN

PHARMACEUTICA NV -

BELGJIKE)

RIREGJ

62/06.02.2013

8.85

1278

RISPERDAL

CONSTA

Prolonged release

powder and solvent

for suspension for

I.M. injection x

25mg/vial

RISPERIDONE

Box x [1 vial of

powder + (1 pre-

filled syringe of

diluent x 2ml) +

1 needle-free

vial access

device (alaris) +

2 safety needle

for

administration]

JANSSEN-CILAG AG -

ZVICER

ALKERMES CONTROLLED

THERAPEUTICS II - SHBA,

VETTER PHARMA-

FERTIGUNG GMBH & CO.

KG - GJERMANI, CILAG AG -

ZVICER, (APL : CILAG AG -

ZVICER)

RIREGJ.

295/14.05.2009

71.58

Page 170

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171

1279

RISPERDAL

CONSTA

Prolonged release

powder and solvent

for suspension for

I.M. injection x

37.5mg/vial

RISPERIDONE

Box x [1 vial of

powder + (1 pre-

filled syringe of

diluent x 2ml) +

1 needle-free

vial access

device (alaris) +

2 safety needle

for

administration]

JANSSEN-CILAG AG -

ZVICER

ALKERMES CONTROLLED

THERAPEUTICS II - SHBA,

VETTER PHARMA-

FERTIGUNG GMBH & CO.

KG - GJERMANI, CILAG AG -

ZVICER, (APL : CILAG AG -

ZVICER)

RIREGJ.

295/14.05.2009

104.63

1280

RISPERDAL

CONSTA

Prolonged release

powder and solvent

for suspension for

I.M. injection x

50mg/vial

RISPERIDONE

Box x [1 vial of

powder + (1 pre-

filled syringe of

diluent x 2ml) +

1 needle-free

vial access

device (alaris) +

2 safety needle

for

administration]

JANSSEN-CILAG AG -

ZVICER

ALKERMES CONTROLLED

THERAPEUTICS II - SHBA,

VETTER PHARMA-

FERTIGUNG GMBH & CO.

KG - GJERMANI, CILAG AG -

ZVICER, (APL : CILAG AG -

ZVICER)

RIREGJ.

295/14.05.2009

135.45

1281

SIBELIUM Tablets x 5mg

FLUNARIZINE (as

FLUNARIZINE

HYDROCHLORIDE X

5.89mg)

Box x 20JANSSEN-CILAG AG -

ZVICER

JANSSEN-CILAG SPA - ITALI

(APL: CILAG AG - ZVICER)

REGJ.

192/19.03.2009

2.5

1282

VELCADE

Powder for solution

for injection I.V. x

3.5 mg/vial

BORTEZOMIB (as

MANNITOL BORONIC

ESTER)

Box x 1 Vial

JANSSEN-CILAG

INTERNATIONAL N.V. -

BELGJIKE

BEN VENUE

LABORATORIES INC - SHBA,

JANSSEN PHARMACEUTICA

NV - BELGJIKE; BSP

PHARMACEUTICALS SRL -

ITALI (APLIKANT: CILAG AG -

ZVICER)

REGJ.

714/24.12.2008

947.8

Page 171

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172

1283

VERMOXSuspension for oral

use x 20mg/mlMEBENDAZOLE

Box x 1 glass

bottle x 30ml

JOHNSON & JOHNSON

CONSUMER NV/SA -

BELGJIKE

JANSSEN PHARMACEUTICA

NV - BELGJIKE (APLIKANT

PER CERTIFIKATE:

JANSSEN PHARMACEUTICA

NV - BELGJIKE)

REGJ.

307/07.05.2013

1.7

1284

ZYTIGA Tablets x 250mg ABIRATERONE ACETATEBox x plastic

bottle x 120

"JANSSEN-CILAG

INTERNATIONAL NV"

BELGJIKE

"PATHEON INC" KANADA;

"JANSSEN-CILAG SPA" ITALI

dhe me aplikant per çertifikate

"CILAG AG" ZVICER

Regj.

359/28.05.2013

3665.8

1285

VERMOX Tablets x 100ng MEBENDAZOLE Box x 6JOHNSON & JOHNSON

LDA - PORTUGALI

LUSOMEDICAMENTA

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGALI; JANSSEN

CILAG SPA - ITALI (APL:

LUSOMEDICAMENTA

SOCIEDADE TECNICA

FARMACEUTICA SA -

PORTUGAL)

REGJ.

307/07.05.2013

2.1

1286

BRONCHOSTOP

Cough syrup x

(0.6g + 15g + 30g)

/ 100g

ASCORBIC ACID + THYMI

FOLIUM (extract) +

ALTHAEAE RADIX (extract)

Box x 1 flacon x

170g

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.2009

3.4

1287

BIOGELAT

CRANBERRY

UROFORTE

Liquid x (120mg +

60mg)/15ml

CRANBERRY EXTRACT

[CORRESP. TO 36MG OF

PROANTHOCYANIDINS

(PAC)] + VITAMIN C

Box x 1 glass

bottle x 120ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

309/17.05.2010

3.5

1288

BIOGELAT

CRANBERRY

UROFORTE

Film coated tablets

x (120mg + 60mg

+ 10mg)

CRANBERRY EXTRACT

[CORRESP. TO 36MG OF

PROANTHOCYANIDINS

(PAC)] + VITAMIN C +

VITAMIN E

Box x 30KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

309/17.05.2010

7

1289

HARMOMED

Sugar-coated

tablets x (14mg +

2.5mg)

DOSULEPIN

HYDROCHLORIDE +

DIAZEPAM

Box x 30,KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.20092.25

Page 172

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173

1290

HARMOMED

FORTE

Sugar-coated

tablets x (28mg +

5mg)

DOSULEPIN

HYDROCHLORIDE ( = 25mg

Dosulepin)+ DIAZEPAM

Box x 30KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.2009

3.3

1291

HARMOMED

FORTE

Sugar-coated

tablets x (28mg +

5mg)

DOSULEPIN

HYDROCHLORIDE ( = 25mg

Dosulepin)+ DIAZEPAM

Box x 60KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.2009

5.1

1292

HARMOMED

Sugar-coated

tablets x (14mg +

2.5mg)

DOSULEPIN

HYDROCHLORIDE +

DIAZEPAM

Box x 100,KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.20095.1

1293

CO-ENARANTablets x (20mg +

12.5mg)

ENALAPRIL MALEATE +

HYDROCHLOROTHIAZIDEBox x 28

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

266/12.06.2012

5.81

1294

BRONCHOSTOP

Cough drops

solution x (25g +

5g) / 100g

EVAKULAT THYMI COMP. +

GUAIFENESIN

Box x 1 flacon x

20ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.20091.6

1295

BRONCHOSTOP

Cough drops

solution x (25g +

5g) / 100g

EVAKULAT THYMI COMP. +

GUAIFENESIN

Box x 1 flacon x

50ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.20092.8

1296

KRATALGIN

200MG

Film coated tablets

x 200mgIBUPROFEN Box x 30

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

71/09.02.2010 1.79

1297

TRAUMA-

OINTMENT

COOLING

"MAYRHOFER"

Ointment x (5g +

1.5g + 1.5g) / 100g

METHYL SALICYLATE +

MENTHOL + CAMPHOR

Box x 1 tube x

40g

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.2009

1.9

1298ERGOTOP

Film coated tablets

x 30mgNICERGOLINE Box x 28

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

311/17.05.2010 7

1299

ADOLORINTablets x (50mg +

250mg + 300mg)

CAFFEINE +

PROPYPHENAZONE +

PARACETAMOL

Box x 30KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

190/27.04.20123.05

1300RAMERAN Tablets x 5mg RAMIPRIL Box x 28

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

332/29.08.2011 5.43

1301RAMERAN Tablets x 10mg RAMIPRIL Box x 28

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

332/29.08.2011 6.43

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174

1302

LEATON CLASSIC

Oral solution x

(1200μg + 4.6mg +

5.3mg + 50mg +

26.7mg + 4.4mg +

333.3mg + 11μg +

5.6mg + 0.33mg +

250mg)/100ml

RETINOL PALMITATE +

THIAMINE

HYDROCHLORIDE +

RIBOFLAVIN SODIUM

PHOSPHATE +

NICOTINAMIDE + D-

PANTHENOL +

PYRIDOXINE

HYDROCHLORIDE + L-

ASCORBIC ACID +

CHOLECALCIFEROL + α-

TOCOPHEROL ACETATE +

BIOTIN + COFFEIN

Glass bottle x

500ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

344/03.06.2010

4.52

1303

LEATON KINDER

Oral solution x

(1555μg + 6mg +

6mg + 66.67mg +

23.69mg + 3.33mg

+ 466mg + 33μg +

3.15mg +

100μg)/100ml

RETINOL PALMITATE +

THIAMINE

HYDROCHLORIDE +

RIBOFLAVIN SODIUM

PHOSPHATE +

NICOTINAMIDE + D-

PANTHENOL +

PYRIDOXINE

HYDROCHLORIDE + L-

ASCORBIC ACID +

CHOLECALCIFEROL + α-

TOCOPHEROL ACETATE +

BIOTIN

Glass bottle x

500ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

RIREGJ.

344/03.06.2010

4.52

1304BRONCHOSTOP

Cough pastilles,

oral use x 85mgTHYMI HERBA (EXTRACT)

Box x 20

pastilles

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

580/29.10.2010 2.6

1305

BRONCHOSTOP

Oromucosal spray

solution x (0.32g +

0.32g + 0.32g) / 1g

SALVIAE FOLIUM (extract) +

THYMI FOLIUM (extract) +

FOLIUM MENTHAE

PIPERITAE (extract)

Box x 1 flacon x

15ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

467/04.09.2009

2.6

1306

VERALGIN

Mouth & gingival

spray x (1g +

5g)/100g

SALVIAE FOLIUM

(EXTRACT) +

DEXPANTHENOL

Box x 1 glass

bottle x 15ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

580/29.10.20102.6

Page 174

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175

1307

BRONCHOSTOP

SINE

Cough syrup,

solution x (0.77g +

7.69g)/100g

THYMI HERBA (extract)

0.17g/15ml + ALTHAEAE

RADIX (extract) 3.4g/15ml

Box x 1 glass

bottle x 120ml

KWIZDA PHARMA GMBH -

AUSTRI

KWIZDA PHARMA GMBH -

AUSTRI

REGJ.

206/20.05.2011

3.2

1308

CALCILAC BT

Effervescent

tablets x (1000mg

+ 880 IU)

CALCIUM CARBONATE +

CHOLECALCIFEROLBox x 20

MIBE

VERTRIEBSGESELLSCH

AFT MBH - GJERMANI

LOSAN PHARMA GMBH -

GJERMANI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

471/31.08.2010

4

1309

CUTASON Tablets x 20 mg PREDNISONE Box x 20

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

Riregj.458/19.08.201

32.4

1310

CUTASON 50 mg Tablets x 50 mg PREDNISONE Box x 10

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

596/31.10.20083

1311

JENAPROFEN

600MG

Film coated tablets

x 600mgIBUPROFEN Box x 20

MIBE

VERTRIEBSGESELLSCH

AFT MBH - GJERMANI

ALLPHAMED PHARBIL

ARZNEIMITTEL GMBH -

GJERMANI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

252/23.04.2009

2

1312

JENAPROFEN

RETARD 800MG

Prolonged-release

tablets x 800mgIBUPROFEN Box x 20

MIBE

VERTRIEBSGESELLSCH

AFT MBH - GJERMANI

ALLPHAMED PHARBIL

ARZNEIMITTEL GMBH -

GJERMANI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

252/23.04.2009

2.5

1313

JENAPURINOL Tablets x 300mg ALLOPURINOL Box x 50

MIBE

VERTRIEBSGESELLSCH

AFT MBH - GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

252/23.04.2009

4

1314

LISIDIGAL Tablets x 5mg

LISINOPRIL (AS

LISINOPRIL DIHYDRATE x

5.44mg )

Box x 50

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

GEDEON RICHTER LTD -

HUNGARI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

180/18.03.2009

6

1315

LISIDIGAL Tablets x 10mg

LISINOPRIL (AS

LISINOPRIL DIHYDRATE x

10.89mg)

Box x 30

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

GEDEON RICHTER LTD -

HUNGARI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

180/18.03.2009

4.2

1316

LISIDIGAL Tablets x 20mg

LISINOPRIL (AS

LISINOPRIL DIHYDRATE x

20.77mg)

Box x 30

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

GEDEON RICHTER LTD -

HUNGARI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

180/18.03.2009

5.4

Page 175

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176

1317

LISIDIGAL HCT Tablets x (10mg +

12.5mg)

LISINOPRIL (AS

LISINOPRIL DIHYDRATE x

10.89 mg) +

HYDROCHLOROTHIAZIDE

Box x 30

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

180/18.03.2009

4.8

1318

LISIDIGAL HCT Tablets x (20mg +

12.5mg)

LISINOPRIL (AS

LISINOPRIL DIHYDRATE x

21.78 mg) +

HYDROCHLOROTHIAZIDE

Box x 30

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI; DEXCEL LTD -

IZRAEL

REGJ.

180/18.03.2009

6

1319

NITRENDIPIN

10MG

JENAPHARM

Tablets x 10mg NITRENDIPINE Box x 50

MIBE

VERTRIEBSGESELLSCH

AFT MBH - GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

252/23.04.2009

3.5

1320

NITRENDIPIN

10MG

JENAPHARM

Tablets x 10mg NITRENDIPINEBox x 100 (for

hospital use)

MIBE

VERTRIEBSGESELLSCH

AFT MBH - GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

252/23.04.2009

7

1321

TEMAGIN

PARACETAMOL

PLUS

Tablets x (350mg +

50mg)

PARACETAMOL +

CAFFEINEBox x 20

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

471/31.08.20101.8

1322

TEMAGIN PACTablets x (250mg +

250mg + 50mg)

ACETYLSALICYLIC ACID +

PARACETAMOL +

CAFFEINE

Box x 20

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

471/31.08.20102

1323

JENASPIRON Tablets x 50mg SPIRONOLACTONE Box x 20

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

471/31.08.20102

1324

DYTIDE HTablets x (50mg +

25mg)

TRIAMTEREN +

HYDROCHLOROTHIAZIDEBox x 30

MIBE GMBH

ARZNEIMITTEL -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

471/31.08.20102.4

1325

BUDAPP NASAL

Nasal spray,

suspension x

50µg/dose

BUDESONIDE (one

actuation of spraying of

50.95mg of the nasal spray,

suspension contains 0.05mg

budesonide)

Box x 1

amber/brown

glass bottle with

a spray pump x

10ml x 200

actuations

DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

358/10.06.2009

3.5

1326

CLODERM

CREME 1%Cream x 10mg/1g CLOTRIMAZOLE

Box x 1 tube x

20g

DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

358/10.06.20093

Page 176

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177

1327

DERMOSOLON Tablets x 5mg PREDNISOLONE Box x 20DERMAPHARM AG -

GJERMANI

DRAGENOPHARM

APOTHEKER PUSCHL GMBH

- GJERMANI; MIBE GMBH

ARZNEIMITTEL - GJERMANI

REGJ.

471/31.08.2010

4

1328

INDERM GEL 4% Gel x 1g/25g ERYTHROMYCINBox x 1 tube x

25g

DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

358/10.06.20094.85

1329

KARISON CREME Cream x 0.5mg/1gCLOBETASOL

PROPIONATE

Box x 1 tube x

15g

DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

456/06.08.20103

1330

KARISON SALBEOintment x

0.5mg/1g

CLOBETASOL

PROPIONATE

Box x 1 tube x

15g

DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

456/06.08.20103

1331

SODERM LOTIO Emulsion x 1mg/1g

BETAMETHASONE (as

BETAMETHASONE

VALERATE x 1.22mg/1g)

Box x 1 plastic

bottle with

dropper x 20ml

DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

358/10.06.2009

2.75

1332

METYSOLON Tablets x 4mg METHYLPREDNISOLONE Box x 10DERMAPHARM AG -

GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

358/10.06.20091.4

1333

NYSTADERM-S

Oromucosal

suspension x 100

000 IE/ml

NYSTATINEBox x 1 glass

bottle x 48ml

DERMAPHARM AG -

GJERMANI MIBE GMBH - GJERMANI

REGJ.

596/26.11.20124

1334

NEVRINE

CODEINE

Tablets x (500mg +

50mg + 30mg)

PARACETAMOL +

CAFFEINE + CODEINE

PHOSPHATE

HEMIHYDRATE

Box x 20LABORATOIRES STEROP

NV - BELGJIKE

LABORATOIRES STEROP

NV - BELGJIKEREGJ. 45/30.01.2012

2.91

1335

FUSIDINSAURE

ACIS Cream x 20mg/1g

FUSIDIC ACID (as FUSIDIC

ACID HEMIHYDRATE x

20.30mg/g)

Box x 1 tube x

5g

ACIS ARZNEIMITTEL

GMBH - GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

456/06.08.2010

2.5

1336

FUSIDINSAURE

ACIS

Ointment x

20mg/1g

FUSIDIC ACID (as FUSIDIC

ACID HEMIHYDRATE x

20.30mg/g)

Box x 1 tube x

5g

ACIS ARZNEIMITTEL

GMBH - GJERMANI

MIBE GMBH ARZNEIMITTEL -

GJERMANI

REGJ.

456/06.08.2010

2.5

1337

ALFASIDFilm coated tablets

x 750mg

SULTAMICILLIN TOSYLATE

DEHYDRATEBottle x 14

ACTAVIS ILACLARI AS -

TURQI

BILIM ILAC SAN.VE TIC. AS -

TURQI

Riregj.423/11.07.201

39

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178

1338

BISALAXGastro-resistant

tablets x 5mgBISACODYL Box x 30

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI

RIREGJ.

351/31.07.20120.88

1339

CARBOPLATIN

SINDAN

Concentrate for

solution for infusion

x 10mg/ml

CARBOPLATINBox x 1vial x

5mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

13

1340

CARBOPLATIN

SINDAN

Concentrate for

solution for infusion

x 10mg/ml

CARBOPLATINBox x 1vial x

15ml; ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

31

1341

CARBOPLATIN

SINDAN

Concentrate for

solution for infusion

x 10mg/ml

CARBOPLATINBox x 1vial x

45ml; ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

90

1342

CARBOPLATIN

SINDAN

Concentrate for

solution for infusion

x 10mg/ml

CARBOPLATINBox x 1vial x

60ml ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

125

1343

CEFAZOLIN

ACTAVIS

Powder for

injection x 1g

CEFAZOLIN (as

CEFAZOLIN SODIUM x

1.048g)

Box x 10 vialsACTAVIS EAD -

BULLGARI

BALKANFARMA-RAZGRAD

AD - BULLGARI (APLIKANT:

BALKANFARMA-RAZGRAD

AD - BULLGARI)

REGJ.

369/17.06.2009

7

1344

COFFERGAMINFilm-coated tablets

x (100mg + 1mg)

CAFFEINE + ERGOTAMINE

TARTRATEBox x 20

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

RIREGJ.

676/31.12.2010

1.54

1345

DEX - TOBRIN

Eye drops

suspension x (1mg

+ 4.57mg)/ml

DEXAMETHASONE +

TOBRAMYCIN SULPHATE

Box x 1 flacon x

5ml

ACTAVIS EAD -

BULLGARI

BALKANFARMA - RAZGRAD

AD - BULLGARI, (APL :

BALKANFARMA - RAZGRAD

AD - BULLGARI)

REGJ.

284/11.05.2009

1.9

Page 178

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179

1346

EFISOL

Compressed

lozenges x (30mg

+ 0.25mg)

ASCORBIC ACID +

DEQUALINUM CHLORIDEBox x 20

ACTAVIS EAD -

BULLGARI

BALKANPHARMA -

DUPNITSA AD - BULLGARI

(APL; BALKANPHARMA -

DUPNITSA AD- BULLGARI)

RIREGJ.

578/02.11.2009

1.5

1347

EPISINDAN 10MG

Powder for solution

for injection x

10mg/flacon

EPIRUBICIN

HYDROCHLORIDEBox x 1 flacon ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

RIREGJ.

266/19.04.2013

25

1348

EPISINDAN 50MG

Powder for solution

for injection x

50mg/flacon

EPIRUBICIN

HYDROCHLORIDEBox x 1 flacon ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

RIREGJ.

266/19.04.2013

58

1349

FELORAN

ACTAVISGel x 1 % DICLOFENAC SODIUM

Box x 1 tube x

60 g

BALKANPHARMA-

TROYAN AD - BULLGARI

BALKANPHARMA-TROYAN

AD - BULLGARI

REGJ.

715/24.12.20081.98

1350

FOLCASIN

Solution for

injection x

30mg/10ml

FOLINIC ACID (as CALCIUM

FOLINATE x 32.41mg/10ml)Box x 1 vial ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI; ACTAVIS ITALY

SPA - ITALI

REGJ.

192/19.03.2009

23

1351

GEMCITABIN

ACTAVIS

Powder for solution

for infusion x

200mg/vial

LYOPHILISAT:

GEMCITABINE (as

GEMCITABINE

HYDROCHLORIDE x

228mg)

Box x 1 vialACTAVIS GROUP PTC

EHF - ISLANDE

S.C SINDAN-PHARMA SRL -

RUMANI; ACTAVIS NORDIC

A/S - DANIMARKE; ACTAVIS

ITALY SPA - ITALI (APL:

ACTAVIS GMBH - AUSTRI)

REGJ.

205/20.05.2011

70

1352

GEMCITABIN

ACTAVIS

Powder for solution

for infusion x

1g/vial

LYOPHILISAT:

GEMCITABINE (as

GEMCITABINE

HYDROCHLORIDE x

1140mg)

Box x 1 vialACTAVIS GROUP PTC

EHF - ISLANDE

S.C SINDAN-PHARMA SRL -

RUMANI; ACTAVIS NORDIC

A/S - DANIMARKE; ACTAVIS

ITALY SPA - ITALI (APL:

ACTAVIS GMBH - AUSTRI)

REGJ.

205/20.05.2011

140

1353

IMOPER Syrup x 667 mg/ml LACTULOSEBox x 1 bottle x

200 ml

BALKANPHARMA-

TROYAN AD - BULLGARI

BALKANPHARMA-TROYAN

AD - BULLGARI

REGJ.

715/24.12.20082.87

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180

1354

INDOVASINGel x (20 mg/g +

30 mg/g)

TROXERUTIN +

INDOMETACIN

Box x 1 tube x

45 g

BALKANPHARMA-

TROYAN AD - BULLGARI

BALKANPHARMA-TROYAN

AD - BULLGARI

REGJ.

715/24.12.20082.71

1355

IRINOTESIN

Concentrate for

solution for infusion

x 20mg/ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE

Box x 1vial x

2mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI; ACTAVIS ITALY

SPA - ITALI

REGJ.

252/23.04.2009

70

1356

IRINOTESIN

Concentrate for

solution for infusion

x 20mg/ml

IRINOTECAN

HYDROCHLORIDE

TRIHYDRATE

Box x 1vial x

5mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI; ACTAVIS ITALY

SPA - ITALI

REGJ.

252/23.04.2009

122

1357

LEVOFLOXACINA

ACTAVIS

Film-coated tablets

x 500mg

LEVOFLOXACIN (as

LEVOFLOXACIN

HEMIHYDRATE x 512.46mg)

Box x 7ACTAVIS GROUP PTC

EHF - ISLANDE

ACTAVIS LTD - MALTE,

ACTAVIS HF - ISLANDE

(APL: ACTAVIS GROUP PTC

EHF - ISLANDE)

REGJ.

140/15.04.2011

16.5

1358

NEUROBEX

Coated tablets x

(15mg + 10mg +

0.02mg)

THIAMINE NITRATE +

PYRIDOXINE

HYDROCHLORIDE +

CYANOCOBALAMIN

Box x 30ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

RIREGJ.

506/06.12.2011

1.21

1359

PANTOGEL Gel x 50mg/g DEXPANTHENOLBox x tube x

40g

ACTAVIS EAD -

BULLGARI

BALKANFARMA-TROYAN AD

- BULLGARI (APL:

BALKANFARMA-TROYAN AD

- BULLGARI)

REGJ.

252/23.04.2009

3

1360

PAPAVERIN

ACTAVISTablets x 50mg

PAPAVERINE

HYDROCHLORIDEBox x 40

ACTAVIS EAD -

BULLGARI

BALKANPHARMA -

DUPNITSA AD - BULLGARI

(APL; BALKANPHARMA -

DUPNITSA AD- BULLGARI)

RIREGJ.

578/02.11.2009

0.93

1361

PAXETINFilm coated tablets

x 20mg

PAROXETINE

HYDROCHLORIDE x

22.22MG

CORRESPONDING TO

PAROXETINE x 20MG

Box x 30ACTAVIS GROUP PTC

EHF - ISLANDE

ACTAVIS LTD - MALTE;

ZDRAVLJE AD - SERBI

REGJ.

396/07.07.2009

8

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181

1362

RAPILYSIN

Powder and

solvent for solution

for injection x 10U

RETEPLASE

Box x 2 vials

with 10U of

powder + 2

prefilled

syringes with

10ml solvent + 2

reconstitution

spikes + 2

needles 19 GI

ACTAVIS GROUP PTC

EHF - ISLANDE

ROCHE DIAGNOSTICS

GMBH - GJERMANI; CENEXI

SAS - FRANCE

REGJ. 23/13.01.2011

700

1363

RUTASCORBINFilm coated tablets

x (100mg + 20mg)

ASCORBIC ACID +

RUTOSIDE Box x 100,

BALKANPHARMA -

DUPNITZA AD -

BULLGARI

BALKANPHARMA -

DUPNITZA AD - BULLGARI

REGJ.

222/08.04.20093

1364

SEDALGIN-NEO

Tablets x (50mg +

10mg + 150mg +

300mg + 15mg)

CAFFEINE + CODEINE

PHOSPHATE

HEMIHYDRATE +

METAMIZOLE SODIUM +

PARACETAMOL +

PHENOBARBITAL

Box x 20ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

RIREGJ.

584/29.10.2010

1.98

1365

SINDAXEL

Concentrate for

solution for infusion

x 6mg/ml

PACLITAXELBox x 1vial x

5mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

33.2

1366

SINDAXEL

Concentrate for

solution for infusion

x 6mg/ml

PACLITAXELBox x 1vial x

25ml; ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

47.2

1367

SINDAXEL

Concentrate for

solution for infusion

x 6mg/ml

PACLITAXELBox x 1vial x

50mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

147.07

1368

SINDAXEL

Concentrate for

solution for infusion

x 100mg/16.67

PACLITAXELUMBox x 1 vial x

16.67mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

RIREGJ.

266/19.04.2013

150.4

1369

SINDOVIN

Powder for solution

for

injection/infusion,

intravenous use x

1mg/vial

VINCRISTINE SULPHATE Box x 1 vial ACTAVIS SRL - RUMANIS.C. SINDAN-PHARMA SRL -

RUMANI

RIREGJ.

266/19.04.2013

5.6

Page 181

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182

1370

SINDRONAT

Concentrate for

Solution for

Intravenous

Infusion x

300mg/5ml

DISODIUM CLODRONATE

ANHYDROUS (as

DISODIUM CLODRONATE

TETRAHYDRATE x

375mg/5ml)

Box x 1 vial x

5mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

192/19.03.2009

15.2

1371

SINDROXOCIN

10MG

Powder for solution

for infusion x

10mg/5ml

DOXORUBICIN

HYDROCHLORIDEBox x 1 flacon ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

RIREGJ.

266/19.04.2013

9

1372

SINDROXOCIN

50MG

Powder for solution

for infusion x

50mg/25ml

DOXORUBICIN

HYDROCHLORIDEBox x 1 flacon ACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

RIREGJ.

266/19.04.2013

16

1373

SINPLATIN

Concentrate for

solution for infusion

x 1mg/ml

CISPLATINBox x 1vial x

10mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

2.9

1374

SINPLATIN

Concentrate for

solution for infusion

x 1mg/ml

CISPLATINBox x 1vial x

50mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

252/23.04.2009

5.3

1375

SINTOPOZID

Concentrate for

Solution for

Intravenous

Infusion x

100mg/5ml

ETOPOSIDEBox x 1 vial x

5mlACTAVIS SRL - RUMANI

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

192/19.03.2009

5.2

1376

TERCEF

Powder for solution

for injection x

1g/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM)

Box x 5 vials (for

hospital use

only)

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-RAZGRAD

AD - BULLGARI (APL:

BALKANPHARMA-RAZGRAD

AD - BULLGARI)

RIREGJ.

430/24.10.2011

12.5

1377

TOPOGEL Gel x 2.5g/100g KETOPROFENBox x tube x

40g

BALKANPHARMA-

TROYAN AD - BULLGARI

BALKANPHARMA-TROYAN

AD - BULLGARI

REGJ.

252/23.04.20092.5

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183

1378

TROXEVASIN Gel x 2% (20mg/g) TROXERUTINBox x tube x

40g

ACTAVIS EAD -

BULLGARI

BALKANFARMA-TROYAN AD

- BULLGARI (APL:

BALKANFARMA-TROYAN AD

- BULLGARI)

REGJ.

252/23.04.2009

2.47

1379

ABRICEF

Powder for solution

for injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1.048g/vial)

Box x 1 vial, ACTAVIS EAD -

BULLGARI

BALKANPHARMA-RAZGRAD

AD - BULLGARI (APL:

BALKANPHARMA-RAZGRAD

AD - BULLGARI)

REGJ.

418/12.10.2011

2.5

1380

ABRICEF

Powder for solution

for injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1.048g/vial)

Box x 10 vials

(for hospital use

only)

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-RAZGRAD

AD - BULLGARI (APL:

BALKANPHARMA-RAZGRAD

AD - BULLGARI)

REGJ.

418/12.10.2011

22

1381

NERGOLINCoated tablets x

10mg NICERGOLINE Box x 30

ACTAVIS GROUP PTC

EHF - ISLANDE

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

REGJ.

452/31.10.2011

2

1382

CITALOPRAM

ACTAVIS

Film-coated tablets

x 10mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x

12.495mg)

Box x 10ACTAVIS GROUP PTC

EHF - ISLANDE

MEDA MANUFACTURING

GMBH - GJERMANI;

ACTAVIS LTD - MALTE;

DRAGENOPHARM

APOTHEKER PUSCHL GMBH

- GJERMANI (APL: ACTAVIS

GMBH - AUSTRI)

REGJ.

452/31.10.2011

1.45

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184

1383

CITALOPRAM

ACTAVIS

Film-coated tablets

x 20mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x

24.99mg)

Box x 10ACTAVIS GROUP PTC

EHF - ISLANDE

MEDA MANUFACTURING

GMBH - GJERMANI;

ACTAVIS LTD - MALTE;

DRAGENOPHARM

APOTHEKER PUSCHL GMBH

- GJERMANI (APL: ACTAVIS

GMBH - AUSTRI)

REGJ.

452/31.10.2011

1.58

1384

CITALOPRAM

ACTAVIS

Film-coated tablets

x 40mg

CITALOPRAM (as

CITALOPRAM

HYDROBROMIDE x

49.98mg)

Box x 10ACTAVIS GROUP PTC

EHF - ISLANDE

MEDA MANUFACTURING

GMBH - GJERMANI;

ACTAVIS LTD - MALTE;

DRAGENOPHARM

APOTHEKER PUSCHL GMBH

- GJERMANI (APL: ACTAVIS

GMBH - AUSTRI)

REGJ.

452/31.10.2011

2.28

1385

LOSARTAN/HIDR

OCLOROTIAZIDA

ACTAVIS

Film-coated tablets

x (50mg + 12.5mg)

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDEBox x 28

ACTAVIS GROUP PTC

EHF - ISLANDEACTAVIS HF - ISLANDE

REGJ.

452/31.10.2011

4

1386

PHEZAMHard capsules x

(25mg + 400mg)CINNARIZIN + PIRACETAM Box x 60

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

REGJ.

527/23.12.2011

4.62

1387

DOCETAXEL

ACTAVIS

Concentrate and

solvent for solution

for infusion x

20mg/0.5ml

DOCETAXEL

Box x (1 vial x

0.5ml + 1 vial

solvent x 1.5ml)

ACTAVIS GROUP PTC

EHF - ISLANDE

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

528/23.12.2011

100

1388

DOCETAXEL

ACTAVIS

Concentrate and

solvent for solution

for infusion x

80mg/2ml

DOCETAXEL

Box x (1 vial x

2ml + 1 vial

solvent x 6ml)

ACTAVIS GROUP PTC

EHF - ISLANDE

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

528/23.12.2011

200

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185

1389

AZATRILFilm-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.04mg)

Box x 3"ACTAVIS GROUP HF"

ISLANDE

"ACTAVIS HF" ISLANDE;

"ACTAVIS GROUP HF"

ISLANDE

Regj.475/09.09.2013

5.2

1390

MYCONAFINE 1% Cream x 1%TERBINAFINE

HYDROCHLORIDE

Box x 1 tube x

15g

"ACTAVIS EAD"

BULLGARI

"NEXTPHARMA (PHARBIL

WALTROP GMBH)"

GJERMANI

Regj.475/09.09.2013

2.3

1391

FELORAN

ACTAVIS

Prolonged release

tablets x 100mgSODIUM DICLOFENAC Box x 30

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

REGJ.

452/31.10.2011

1.65

1392

DIURETIDINTablets x (25mg +

12.5mg)

TRIAMTERENE +

HYDROCHLOROTHIAZIDEBox x 50

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI;

BALKANPHARMA-RAZGRAD

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

REGJ.

527/23.12.2011

2.1

1393

PENTOXIFYLLIN

ACTAVIS

Prolonged release

tablets x 400mgPENTOXIFYLLINE Box x 20

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-DUPNITSA

AD - BULLGARI (APL:

BALKANPHARMA-DUPNITSA

AD - BULLGARI)

REGJ.

527/23.12.2011

2.1

1394

TOPOTECAN

ACTAVIS

Powder for

concentrate for

solution for infusion

x 4mg/vial

TOPOTECAN

HYDROCHLORIDEBox x 1 vial

ACTAVIS GROUP PTC

EHF - ISLANDE

S.C. SINDAN-PHARMA SRL -

RUMANI

REGJ.

528/23.12.2011

250

1395

PANRAZOLGastro - resistant

tablets x 20mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

22.58mg)

Box x 14

ACTAVIS GROUP PTC

EHF - ISLANDE

(regjistruar ne BULLGARI)

BALKANPHARMA-DUPNITSA

AD - BULLGARI; ACTACVIS

LTD - MALTE; ACTAVIS HF -

ISLANDE

REGJ.

307/07.05.2013

3.7

Page 185

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186

1396

PANRAZOLGastro - resistant

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

22.58mg)

Box x 30

ACTAVIS GROUP PTC

EHF - ISLANDE

(regjistruar ne BULLGARI)

BALKANPHARMA-DUPNITSA

AD - BULLGARI; ACTACVIS

LTD - MALTE; ACTAVIS HF -

ISLANDE

REGJ.

307/07.05.2013

5.7

1397

MUCOLISIN Suryp x 30mg/5mlAMBROXOL

HYDROCHLORIDE

Box x 1 glass

bottle x 100ml

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-TROYAN

AD - BULLGARI; (APL:

BALKANPHARMA-TROYAN

AD - BULLGAR)

REGJ.

307/07.05.2013

2.5

1398

ACETYSAL

CARDIO

Gastro - resistenat

tablets x 100mgACETYLSALICYLIC ACID Box x 30

ACTAVIS GROUP PTC

EHF - ISLANDE

(regjistruar ne BULLGARI)

BALKANPHARMA-DUPNITSA

AD - BULLGARI; ACTACVIS

LTD - MALTE

REGJ.

307/07.05.2013

1.2

1399

CEFTAZIM

Powder for solution

for IM/IV injection

x 1g/vial

CEFTAZIDIME (as

PENTAHYDRATE)

Box x 5 flacons

(for hospital use

only)

ACTAVIS EAD -

BULLGARI

BALKANPHARMA-RAZGRAD

AD - BULLGARI

REGJ.

379/10.08.2012

18

1400

MIRTAZAPINE Film-coated tablets

x 30mgMIRTAZAPINE Box x 28

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

11.2

1401

MIRTAZAPINE Film-coated tablets

x 45mgMIRTAZAPINE Box x 28

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

13.4

1402

PAROXETINEFilm-coated tablets

x 20mg

PAROXETINE

HYDROCHLORIDE

HEMIHYDRATE x 22.2mg

EQUIVALENT TO

PAROXETINE x 20mg

Box x 30

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

5.9

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187

1403

PAROXETINEFilm-coated tablets

x 30mg

PAROXETINE

HYDROCHLORIDE

HEMIHYDRATE x 33.3mg

EQUIVALENT TO

PAROXETINE x 30mg

Box x 30

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

12.4

1404

FURAGINUM

ADAMEDTablets x 50mg FURAGINUM Box x 30

ADAMED SP. Z.O.O. -

POLONI

ADAMED SP. Z.O.O. -

POLONI, PABIANICKIE

ZAKLADY

FARMACEUTYCZNE POLFA

SA - POLONI

REGJ.

617/17.11.2009

6.6

1405

NORIFAZCoated tablets x

35mg

RISEDRONATE SODIUM

EQUIVALENT TO 32.5mg

RISEDRONIC ACID

Box x 4

PHARMACEUTICAL

FACTORY ADAMED

PHARMA SA - POLONI

ADAMED SP. Z.O.O. -

POLONI, PABIANICKIE

ZAKLADY

FARMACEUTYCZNE POLFA

SA - POLONI

REGJ.

614/17.11.2009

18.5

1406

SELOFENGelatin capsules x

10 mgZALEPLONUM Box x 20

ADAMED SP. Z.O.O. -

POLONI

ADAMED SP. Z.O.O. -

POLONI, PABIANICKIE

ZAKLADY

FARMACEUTYCZNE POLFA

SA - POLONI

REGJ.

617/17.11.2009

6.08

1407

ALENDRONAT

ICPTablets x 70 mg

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE x 91.37 mg)

Box x 4INTERCHEMIA HANDELS

GMBH - AUSTRIA

TEVA PHARMA S.L.U. -

SPANJE

REGJ.

581/27.10.2008

16.9

1408

LANSOPRAZOL

ICP 15 mg

Gastroresistant

hard capsules x 15

mg

LANSOPRAZOLEBox x 1 Bottle x

28

INTERCHEMIA HANDELS

GMBH - AUSTRIA

TEVA PHARMA S.L.U. -

SPANJE

REGJ.

581/27.10.20085.25

1409

LANSOPRAZOL

ICP 30 mg

Gastroresistant

hard capsules x 30

mg

LANSOPRAZOLEBox x 1 Bottle x

28

INTERCHEMIA HANDELS

GMBH - AUSTRIA

TEVA PHARMA S.L.U. -

SPANJE

REGJ.

581/27.10.20087.3

1410

TRIMETAZIDIN

ICP

Coated tablets x 20

mg

TRIMETAZIDINE

HYDROCHLORIDEBox x 60

INTERCHEMIA HANDELS

GMBH - AUSTRIA

TEVA PHARMA S.L.U. -

SPANJE

REGJ.

580/27.10.20086.59

1411

SERTRALIN ICP

50 mg

Film coated tablets

x 50 mg

SERTRALINE (as

SERTRALINE

HYDROCHLORIDE x 55.95

mg)

Box x 30INTERCHEMIA HANDELS

GMBH - AUSTRIA

TEVA PHARMA S.L.U. -

SPANJE

REGJ.

580/27.10.2008

5

Page 187

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188

1412

CONTRAHISTFilm-coated tablets

x 5mg

LEVOCETIRIZINE

DIHYDROCHLORIDEBox x 28

ADAMED SP. Z.O.O -

POLONI

PABIANICKIE ZAKLADY

FARMACEUTYCZNE POLFA

SA - POLONI

REGJ. 433/1 Dt.

28.09.20127.55

1413

CONTRAHISTOral solution x

0.5mg/ml

LEVOCETIRIZINE

DIHYDROCHLORIDE

Box x 1 glass

bottle x 200ml +

1 peroral

syringe

ADAMED SP. Z.O.O -

POLONI

MEDANA PHARMA SA -

POLONI

REGJ. 433/1 Dt.

28.09.2012

9

1414

AZYCYNAFilm-coated tablets

x 500mgAZITHROMYCIN Box x 3

"PABIANICKIE ZAKLADY

FARMACEUTYCZNE

POLFA SA" POLONI

"PABIANICKIE ZAKLADY

FARMACEUTYCZNE POLFA

SA" POLONI

Regj.451/13.08.2013

4.2

1415

ZAHRONFilm-coated tablets

x 10mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM)Box x 28

"ZAKLAD

FARMAZEUTYCZNY

ADAMED PHARMA SA"

POLONI

"ZAKLAD

FARMAZEUTYCZNY

ADAMED PHARMA SA"

POLONI

Regj.

359/28.05.2013

6.53

1416

ZAHRONFilm-coated tablets

x 20mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM)Box x 28

"ZAKLAD

FARMAZEUTYCZNY

ADAMED PHARMA SA"

POLONI

"ZAKLAD

FARMAZEUTYCZNY

ADAMED PHARMA SA"

POLONI

Regj.

359/28.05.2013

9.33

1417

FAXIPROLProlonged release

tablets x 75mgVENLAFAXINE Box x 30

IPR BETA PHARMA KFT -

HUNGARILICONSA SA - SPANJE

REGJ.

572/27.10.20094.5

1418

FAXIPROLProlonged release

tablets x 150mgVENLAFAXINE Box x 30

IPR BETA PHARMA KFT -

HUNGARILICONSA SA - SPANJE

REGJ.

572/27.10.20097.5

1419

STODETTE

Coated tablets x

(0.075mg +

0.02mg)

GESTODENE +

ETHINYLESTRADIOLBox x 21

MEDICO UNO PHARMA

KFT - HUNGARI

HAUPT PHARMA MUNSTER

GMBH - GJERMANI;

PHARMA - PACK KFT -

HUNGARI; CEMELOG KFT -

HUNGARI, CEMELOG-BRS

LTD - HUNGARI

REGJ. 98/22.02.2010

4

1420

OMICRAL Capsules x 100mg ITRACONAZOLE Box x 4IPR BETA PHARMA KFT. -

HUNGARI

LICONSA SA - SPANJE;

TJOA PACK HUNGARY

GYOGYSZERGYARTO KFT -

HUNGARI; CEMELOG KFT -

HUNGARI; CEMELOG-BRS

KFT. - HUNGARI

REGJ.

646/10.12.2010

3

Page 188

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189

1421

OMICRAL Capsules x 100mg ITRACONAZOLE Box x 15IPR BETA PHARMA KFT. -

HUNGARI

LICONSA SA - SPANJE;

TJOA PACK HUNGARY

GYOGYSZERGYARTO KFT -

HUNGARI; CEMELOG KFT -

HUNGARI; CEMELOG-BRS

KFT. - HUNGARI

REGJ.

646/10.12.2010

9.5

1422

GLIPREX Tablets x 1mg GLIMEPIRIDE Box x 30MEDICO UNO PHARMA

KFT - HUNGARI

EDMOND PHARMA S.R.L. -

ITALI; TJOA PACK HUNGARY

GYOGYSZERGYARTO KFT. -

HUNGARI; CEMELOG-BRS

KFT - HUNGARI; LAMP S.

PROSPERO - ITALI

REGJ.

569/27.10.2009

1.8

1423

GLIPREX Tablets x 2mg GLIMEPIRIDE Box x 30MEDICO UNO PHARMA

KFT - HUNGARI

EDMOND PHARMA S.R.L. -

ITALI; TJOA PACK HUNGARY

GYOGYSZERGYARTO KFT. -

HUNGARI; CEMELOG-BRS

KFT - HUNGARI; LAMP S.

PROSPERO - ITALI

REGJ.

569/27.10.2009

2.7

1424

GLIPREX Tablets x 3mg GLIMEPIRIDE Box x 30MEDICO UNO PHARMA

KFT - HUNGARI

EDMOND PHARMA S.R.L. -

ITALI; TJOA PACK HUNGARY

GYOGYSZERGYARTO KFT. -

HUNGARI; CEMELOG-BRS

KFT - HUNGARI; LAMP S.

PROSPERO - ITALI

REGJ.

569/27.10.2009

3.8

Page 189

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190

1425

BICATLONFilm coated tablets

x 50mgBICALUTAMIDE Box x 28

IPR BETA PHARMA KFT -

HUNGARI

KOCAK FARMA ILAC VE

KIMYA SANAYI AS - TURQI;

PHARMA - PACK HUNGARY

GYOGYSZERGYARTO KFT -

HUNGARI; CEMELOG KFT -

HUNGARI; CEMELOG-BRS -

HUNGARI; WESSLING

HUNGARY LTD - HUNGARI

REGJ.

739/30.12.2009

50

1426

CORYCARDON

Film-coated tablets

x (150mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 30 AEGIS LTD - QIPRO

AEGIS LTD - QIPRO;

ZHEJIANG HUAHAI

PHARMACEUTICALS CO

LTD - KINE

REGJ.

420/13.10.2011

9

1427

CORYCARDON

Film-coated tablets

x (300mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 30 AEGIS LTD - QIPRO

AEGIS LTD - QIPRO;

ZHEJIANG HUAHAI

PHARMACEUTICALS CO

LTD - KINE

REGJ.

420/13.10.2011

10

1428

REPRATGastro - resistant

tablets x 20mgPANTOPRAZOLE SODIUM Box x 20 AEGIS LTD - QIPRO

AEGIS LTD - QIPRO, AET

LABORATORIES PVT LTD -

INDI, SOFARIMEX -

INDUSTRIA QUIMICA E

FARMACEUTICA LDA -

PORTUGALI, ROTTENDORF

PHARMA GMBH -

GJERMANI, ADVANCE

PHARMA GMBH - GJERMANI

REGJ. 3/07.01.2013

2.15

Page 190

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191

1429

REPRATGastro - resistant

tablets x 40mgPANTOPRAZOLE SODIUM Box x 20 AEGIS LTD - QIPRO

AEGIS LTD - QIPRO, AET

LABORATORIES PVT LTD -

INDI, SOFARIMEX -

INDUSTRIA QUIMICA E

FARMACEUTICA LDA -

PORTUGALI, ROTTENDORF

PHARMA GMBH -

GJERMANI, ADVANCE

PHARMA GMBH - GJERMANI

REGJ. 3/07.01.2013

3.9

1430PARCOTEN

Tablets x (500mg +

10mg)

PARACETAMOL +

CODEINE PHOSPHATEBox x 20 AEGIS LTD - QIPRO AEGIS LTD - QIPRO

RIREGJ.

392/01.07.2009 2.6

1431

DIACOL Syrup x 1.8mg/mlDEXTROMETHORPHAN

HYDROBROMIDE

Box x 1 glass

bottle x 200ml

BIAL-PORTELA & Cª, S.A. -

PORTUGALI

BIAL-PORTELA & Cª, S.A. -

PORTUGALI (APL: BIAL-

PORTELA & Cª, S.A. -

PORTUGALI)

REGJ.

739/30.12.2009

4.31

1432

FOLIFERFilm coated tablets

x (1mg + 90mg)

FOLIC ACID + IRON (as

FERROUS SULFATE x

288mg)

Box x 60

BIALPORT-PRODUTOS

FARMACEUTICOS SA -

PORTUGALI

BIAL-PORTELA & Cª, S.A. -

PORTUGALI (APL: BIAL-

PORTELA & Cª, S.A. -

PORTUGALI)

REGJ.

566/27.10.2009

5.54

1433

MIGRETIL

Film-coated tablets

x (100mg + 400mg

+ 1mg + 0.1mg)

CAFFEINE +

PARACETAMOL +

ERGOTAMINE TARTRATE +

BELLADONNA ALKALOIDS

(0.085MG SCOPOLAMINE

BROM + 0.015MG

ATROPINE SULPHATE)

Box x 20BIAL - PORTELA & C

a,

S.A. - PORTUGALI

BIAL - PORTELA & Ca, S.A. -

PORTUGALI

RIREGJ.

446/03.08.2010

3.8

Page 191

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192

1434

ZEBINIX Tablets x 800mgESLICARBAZEPINE

ACETATEBox x 30

BIAL - PORTELA & Ca,

S.A. - PORTUGALI

PATHEON INC., WHITBY

OPERATIONS - KANADA;

PATHEON INC.,

BURLINGTON CENTURY

OPERATIONS - KANADA;

PATHEON FRANCE -

FRANCE; BIAL - PORTELA &

Ca, S.A. - PORTUGALI, EISAI

MANUFACTURING LIMITED -

MBRETERI E BASHKUAR

REGJ.

562/26.10.2010

133.5

1435

SERTRALINE

AUROBINDO

Film coated tablets

x 50mg

SERTRALINE (as

SERTRALINE

HYDROCHLORIDE x 56mg)

Box x 28

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

2.34

1436

SERTRALINE

AUROBINDO

Film coated tablets

x 100mg

SERTRALINE (as

SERTRALINE

HYDROCHLORIDE x

112mg)

Box x 28

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

4.26

1437

PARACETAMOL

ATBTablet x 500mg PARACETAMOL Box x 20

"S.C. ANTIBIOTICE SA"

RUMANI

"S.C. ANTIBIOTICE SA"

RUMANIRegj.451/13.08.2013

0.6

1438

CLOTRIMAZOLE

ATBCream 10mg/g CLOTRIMAZOLE

Box x 1 tube x

35g

"S.C. ANTIBIOTICE SA"

RUMANI

"S.C. ANTIBIOTICE SA"

RUMANIRegj.451/13.08.2013

2.5

1439

MULTIHANCE

Solution for

injection x

529mg/ml (0.5M)

GADOBENATE

DIMEGLUMINE

Box x 1 bottle x

10mlBRACCO SPA - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA - ITALI

REGJ.

151/15.03.2010

25

1440

MULTIHANCE

Solution for

injection x

529mg/ml (0.5M)

GADOBENATE

DIMEGLUMINE

Box x 1 bottle x

15mlBRACCO SPA - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA - ITALI

REGJ.

151/15.03.2010

35

1441

MULTIHANCE

Solution for

injection x

529mg/ml (0.5M)

GADOBENATE

DIMEGLUMINE

Box x 1 bottle x

20mlBRACCO SPA - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA - ITALI

REGJ.

151/15.03.2010

45

Page 192

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193

1442

IOMERON

Solution for

injection x

300mg/ml

IOMEPROL x 612.4mg/ml

(IODINE x 300mg/ml)

Box x 1 bottle x

50ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

12.4

1443

IOMERON

Solution for

injection x

300mg/ml

IOMEPROL x 612.4mg/ml

(IODINE x 300mg/ml)

Box x 1 bottle x

100ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

24

1444

IOMERON

Solution for

injection x

350mg/ml

IOMEPROL x 714.4mg/ml

(IODINE x 350mg/ml)

Box x 1 bottle x

100 ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

25.8

1445

IOMERON

Solution for

injection x

350mg/ml

IOMEPROL x 714.4mg/ml

(IODINE x 350mg/ml)

Box x 1 bottle x

50ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

13.3

1446

IOMERON

Solution for

injection x

350mg/ml

IOMEPROL x 714.4mg/ml

(IODINE x 350mg/ml)

Box x 1 bottle x

150ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

38.35

1447

IOMERON

Solution for

injection x

350mg/ml

IOMEPROL x 714.4mg/ml

(IODINE x 350mg/ml)

Box x 1 bottle x

200ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

49.7

1448

IOMERON

Solution for

injection x

350mg/ml

IOMEPROL x 714.4mg/ml

(IODINE x 350mg/ml)

Box x 1 bottle x

500ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

122.5

1449

IOMERON

Solution for

injection x

400mg/ml

IOMEPROL x 816.5mg/ml

(IODINE x 400mg/ml)

Box x 1 bottle x

50ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

18.3

Page 193

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194

1450

IOMERON

Solution for

injection x

400mg/ml

IOMEPROL x 816.5mg/ml

(IODINE x 400mg/ml)

Box x 1 bottle x

100ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

35.5

1451

IOMERON

Solution for

injection x

400mg/ml

IOMEPROL x 816.5mg/ml

(IODINE x 400mg/ml)

Box x 1 bottle x

150ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

52.5

1452

IOMERON

Solution for

injection x

400mg/ml

IOMEPROL x 816.5mg/ml

(IODINE x 400mg/ml)

Box x 1 bottle x

200ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

69.6

1453

IOMERON

Solution for

injection x

400mg/ml

IOMEPROL x 816.5mg/ml

(IODINE x 400mg/ml)

Box x 1 bottle x

500ml

BRACCO IMAGING

ITALIA SRL - ITALI

BRACCO SPA - ITALI;

PATHEON ITALIA SPA -

ITALI; SILVANO

CHIAPPAROLI LOGISTICA

SPA - ITALI

REGJ.

432/29.07.2010

165.3

1454

FEXOFENADIN EFilm - coated

tablets x 120mg

FEXOFENADIN

HYDROCHLORIDE (eq. Box x 30

"CHANELLE MEDICAL"

IRLANDE

"CHANELLE MEDICAL"

IRLANDE; "CIPLA LTD" INDIRegj.422/11.07.2013

7.5

1455

AMOROLFINEMedicated nail

lacquer x 5% (w/v)

AMOROLFINE (as

AMOROLFINE

HYDROCHLORIDE)

Box x 1 bottle

packed with

cleaning wipes,

nail files and

spatulas

"CHANELLE MEDICAL"

IRLANDE

"CHANELLE MEDICAL"

IRLANDERegj.422/11.07.2013

12.1

1456

FEXOFENADIN EFilm - coated

tablets x 180mg

FEXOFENADIN

HYDROCHLORIDE Box x 30

"CHANELLE MEDICAL"

IRLANDE

"CIPLA LTD" INDI;

"CHANELLE MEDICAL"

IRLANDE

Regj.451/13.08.2013

12

1457

MELOXICAM

Tablets x 7.5 mg MELOXICAM Box x 30

"CHANELLE MEDICAL"

IRLANDE

"CIPLA LTD" INDI;

"CHANELLE MEDICAL"

IRLANDE

Regj.451/13.08.2013

3.75

1458

MELOXICAM

Tablets x 15 mg MELOXICAM Box x 30

"CHANELLE MEDICAL"

IRLANDE

"CIPLA LTD" INDI;

"CHANELLE MEDICAL"

IRLANDE

Regj.451/13.08.2013

5.25

Page 194

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195

1459

AIMAFIX

Powder and

solvent for solution

for infusion x 500

IU/vial - 10ml

HUMAN PLASMA

COAGULATION FACTOR IX

Box x 1 vial + (1

vial with 10ml

water for

injection +

infusion set)

KEDRION SPA - ITALI KEDRION SPA - ITALIRIREGJ.

470/31.08.2010

150

1460

EMOCLOT

Powder and

solvent for solution

for infusion x 500

IU/10ml

PLASMA DERIVED HUMAN

COAGULATION FACTOR

VIII X 500 IU/VIAL OF

POWDER

Box x (1 vial of

powder + 1 vial

of solvent x

10ml + 1

infusion set)

KEDRION SPA - ITALI KEDRION SPA - ITALIRIREGJ.

35/25.01.2011

150

1461

IMMUNORHO

Powder and

solvent for solution

for IM injection x

300mcg/2ml

HUMAN PLASMA

PROTEINS CONTAINS AT

LEAST 90%

IMMUNOGLOBULIN WITH

ANTIBODIES AGAINST

ERYTHROCYTES Rho (D)

Box x 1 vial of

powder + 1

ampoule of

solvent x 2ml

KEDRION SPA - ITALI

KEDRION SPA - ITALI,

BIOLOGICI ITALIA

LABORATORIES SRL - ITALI

RIREGJ.

380/13.08.2012

35

1462

TETANUS

GAMMA

Solution for I.M

injection x 250

IU/1ml

HUMAN ANTITETANUS

IMMUNOGLOBULIN

Box x 1 pre-

filled syringeKEDRION SPA - ITALI KEDRION SPA - ITALI

RIREGJ.

35/25.01.20119

1463

IG VENASolution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN

50MG/ML. HUMAN

PROTEINS 50G/L OF

WHICH IgG AT LEAST 95%.

IgG SUBCLASSES: IgG1

24.3-37.2MG, IgG2 12.4-

22.1MG, IgG3 0.9-1.5MG,

IgG4 0.1-0.5MG. MAXIMUM

IgA CONTENT 0.05MG.

Box x 1 vial x

20ml + infusion

set

KEDRION SPA - ITALI KEDRION SPA - ITALI REGJ. 24/13.01.2011

40

Page 195

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196

1464

IG VENASolution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN

50MG/ML. HUMAN

PROTEINS 50G/L OF

WHICH IgG AT LEAST 95%.

IgG SUBCLASSES: IgG1

24.3-37.2MG, IgG2 12.4-

22.1MG, IgG3 0.9-1.5MG,

IgG4 0.1-0.5MG. MAXIMUM

IgA CONTENT 0.05MG.

Box x 1 vial x

50ml + infusion

set

KEDRION SPA - ITALI KEDRION SPA - ITALI REGJ. 24/13.01.2011

120

1465

IG VENASolution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN

50MG/ML. HUMAN

PROTEINS 50G/L OF

WHICH IgG AT LEAST 95%.

IgG SUBCLASSES: IgG1

24.3-37.2MG, IgG2 12.4-

22.1MG, IgG3 0.9-1.5MG,

IgG4 0.1-0.5MG. MAXIMUM

IgA CONTENT 0.05MG.

Box x 1 vial x

100ml + infusion

set

KEDRION SPA - ITALI KEDRION SPA - ITALI REGJ. 24/13.01.2011

200

1466

IMMUNOHBS

Solution for IM

injection x 180

UI/1ml

HUMAN ANTI-HEPATITIS B

IMMUNOGLOBULIN

Box x 1 flacon x

1mlKEDRION SPA - ITALI KEDRION SPA - ITALI

REGJ.

188/12.05.201150

1467

IMMUNOHBS

Solution for IM

injection x 1000

UI/3ml

HUMAN ANTI-HEPATITIS B

IMMUNOGLOBULIN

Box x 1 pre-

filled syringe x

3ml

KEDRION SPA - ITALI KEDRION SPA - ITALIREGJ.

188/12.05.2011200

1468

IMMUNOHBS

Solution for IM

injection x 540

UI/3ml

HUMAN ANTI-HEPATITIS B

IMMUNOGLOBULIN

Box x 1 flacon x

3mlKEDRION SPA - ITALI KEDRION SPA - ITALI

REGJ.

188/12.05.2011120

1469

TERRELL Liquid for inhalation ISOFLURANE Box x 1 bottle x

250 mlMINRAD INC. - SHBA MINRAD INC. - SHBA

REGJ.

596/31.10.200890

1470

TERRELL Liquid for inhalation ISOFLURANEBox x 1 bottle x

100 mlMINRAD INC. - SHBA MINRAD INC. - SHBA

REGJ.

596/31.10.200840

Page 196

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197

1471

FENTANYL WZFSolution for

injection x 50µg/mlFENTANYL

Box x 5

ampoules x 2ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

289/06.05.2010

3.5

1472

FENTANYL WZFSolution for

injection x 50µg/mlFENTANYL

Box x 50 amp x

10ml (for

hospital use

only)

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

289/06.05.2010

80

1473

BUPIVACAINUM

HYDROCHLORICU

M WZF

Solution for

injection x 0.5%

BUPIVACAINE

HYDROCHLORIDE x 5mg/ml

Box x 10

ampoules x

10ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

289/06.05.2010

13

1474

MIDANIUMSolution for

injection x 1mg/1mlMIDAZOLAM

Box x 10

ampoules x 5ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

292/06.05.2010

7

1475

MIDANIUM

Solution for

injection x

15mg/3ml

MIDAZOLAMBox x 5

ampoules x 3ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

292/06.05.2010

7.8

1476

MIDANIUM

Solution for

injection x

50mg/10ml

MIDAZOLAM

Box x 5

ampoules x

10ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

292/06.05.2010

24

1477

NOZETAL 0.05%Nasal drops,

solution x 0.5mg/ml

XYLOMETAZOLINE

HYDROCHLORIDE

Box x 1 plastic

bottle x 10ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

418/12.10.2011

1.9

1478

NOZETAL 0.1%Nasal drops,

solution x 1mg/ml

XYLOMETAZOLINE

HYDROCHLORIDE

Box x 1 plastic

bottle x 10ml

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

418/12.10.2011

2

Page 197

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198

1479

RELSEDRectal solution x

2mg/mlDIAZEPAM

Box x 5 rectal

microenemas of

2.5ml,

polyethylene

horn with

cannula

(microenema) in

aluminium-

paper foil in the

carton

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

449/28.10.2011

3.6

1480

RELSEDRectal solution x

4mg/mlDIAZEPAM

Box x 5 rectal

microenemas of

2.5ml,

polyethylene

horn with

cannula

(microenema) in

aluminium-

paper foil in the

carton

WARSAW

PHARMACEUTICAL

WORKS POLFA SA -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA SA - POLONI

REGJ.

449/28.10.2011

4

1481

PLOFED 1%

Emulsion for

injection/infusion x

10mg/ml

PROPOFOL

Box x 5 vials x

20ml (for

hospital use

only)

WARSAW

PHARMACEUTICAL

WORKS POLFA S.A -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA S.A - POLONI

REGJ.

604/27.11.2012

19.5

1482

HEPARINUM WZF

Solution for

injection x 25000

IU/5ml

HEPARIN SODIUM

Box x 10 vials x

5ml (for hospital

use only)

WARSAW

PHARMACEUTICAL

WORKS POLFA S.A -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA S.A - POLONI

REGJ.

604/27.11.2012

35

1483

PROXACIN 1%

Concentrate for

solution for infusion

x 100mg/10ml

CIPROFLOXACINBox x 10 vials x

10ml

WARSAW

PHARMACEUTICAL

WORKS POLFA S.A -

POLONI

WARSAW

PHARMACEUTICAL WORKS

POLFA S.A - POLONI

REGJ.

604/27.11.2012

8

1484

ACLASTA

Solution for

infusion x

5mg/100ml

ZOLEDRONIC ACIDBox x 1 bottle x

100ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

450/31.10.2011

280

Page 198

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199

1485

AFINITOR Tablets x 10mg EVEROLIMUS Box x 30NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER; NOVARTIS

PHARMA AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

REGJ. 74/17.02.2012

3302

1486

ANAFRANIL

Aqueous injectable

solution x

25mg/2ml

CLOMIPRAMINE

HYDROCHLORIDE

Box x 10

ampoules x 2ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA LTD -

ZVICER)

RIREGJ.

190/12.05.2011

3.16

1487 CERTICAN

Dispersibile tablets

x 0.25 mg EVEROLIMUS Box x 60

"NOVARTIS PHARMA

SCHWEIZ AG" ZVICER

"NOVARTIS PHARMA STEIN

AG" ZVICER; "NOVARTIS

PHARMA AG" ZVICER dhe

me aplikant per "NOVARTIS

PHARMA AG" ZVICER

Riregj.

385/ 17.06.2013

90.94

1488 CERTICAN Tablets x 0.5 mg EVEROLIMUS Box x 60

"NOVARTIS PHARMA

SCHWEIZ AG" ZVICER

"NOVARTIS PHARMA STEIN

AG" ZVICER; "NOVARTIS

PHARMA AG" ZVICER dhe

me aplikant per "NOVARTIS

PHARMA AG" ZVICER

Riregj.

385/ 17.06.2013

188.17

1489 CERTICAN Tablets x 0.25 mg EVEROLIMUS Box x 60

"NOVARTIS PHARMA

SCHWEIZ AG" ZVICER

"NOVARTIS PHARMA STEIN

AG" ZVICER; "NOVARTIS

PHARMA AG" ZVICER dhe

me aplikant per "NOVARTIS

PHARMA AG" ZVICER

Riregj.

385/ 17.06.2013

90.94

Page 199

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200

1490

CUBICINPowder for infusion

x 350mgDAPTOMYCIN Box x 1 flacon

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

OSO

BIOPHARMACEUTICALS

MANUFACTURING LLC -

SHBA, HOSPIRA INC - SHBA,

NOVARTIS

PHARMACEUTICALS UK

LIMITED - MBRETERI E

BASHKUAR, GEN-PROBE

LIFE SCIENCES LTD UK -

MBRETERI E BASHKUAR

(APLIKANT: NOVARTIS

PHARMA AG - ZVICER)

REGJ.

580/27.10.2008

69.95

1491

CUBICINPowder for infusion

x 500mgDAPTOMYCIN Box x 1 flacon

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

OSO

BIOPHARMACEUTICALS

MANUFACTURING LLC -

SHBA, HOSPIRA INC - SHBA,

NOVARTIS

PHARMACEUTICALS UK

LIMITED - MBRETERI E

BASHKUAR, GEN-PROBE

LIFE SCIENCES LTD UK -

MBRETERI E BASHKUAR

(APLIKANT: NOVARTIS

PHARMA AG - ZVICER)

REGJ.

580/27.10.2008

98.28

1492

DIOVANFilm coated tablets

x 40mgVALSARTAN Box x 28

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, NOVARTIS

FARMACEUTICA SA -

SPANJE (APLIKANT:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

43/28.01.2009

12.89

1493

EXELON

Transdermal patch

x 9.5 mg/24 h (18

mg/10 cm2)

RIVASTIGMINE

Box x 30

sachets ( 1

sachet contain 1

transdermal

patch)

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

LTS LOHMANN THERAPIE-

SYSTEME AG - GJERMANI

REGJ.

153/04.03.2009

58.49

Page 200

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201

1494

EXELON

Transdermal patch

x 4.6 mg/24 h (9

mg/5 cm2)

RIVASTIGMINE

Box x 30

sachets ( 1

sachet contain 1

transdermal

patch)

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

LTS LOHMANN THERAPIE-

SYSTEME AG - GJERMANI

REGJ.

153/04.03.2009

58.49

1495

GALVUS Tablets x 50mg VILDAGLIPTIN Box x 28NOVARTIS PHARMA

SCHWEIZ LTD - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER (APLIKANT PER

CERTIFIKATE: NOVARTIS

PHARMA LTD - ZVICER)

REGJ.

284/11.05.2009

18

1496

GILENYAHard capsules x

0.5mgFINGOLIMOD Box x 28

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

REGJ.

345/26.07.2012

1586.1

1497

GLIVECFilm coated tablets

x 400mg

IMATINIB CORRESP. TO

478MG IMATINIB

MESYLATE

Box x 30NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

672/08.12.2009

2381

1498

LAMISIL Tablets x 125mg

TERBINAFINE (as

TERBINAFINE

HYDROCHLORIDE)

Box x 14NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS

PHARMACEUTICALS UK

LTD" MBRETËRI E

BASHKUAR (APLIKANT:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

266/19.04.2013

6.05

1499

LEPONEX Tablets x 25mg CLOZAPINE Box x 50NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

NOVARTIS

PHARMACEUTICALS UK

LTD" MBRETËRI E

BASHKUAR (APLIKANT:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

165/24.03.2010

3.92

1500 LUCENTIS

Solution for

injection x 10mg/ml RANIBIZUMAB Box x 1 vial

"NOVARTIS PHARMA

SCHWEIZ AG" ZVICER

"NOVARTIS PHARMA STEIN

AG" ZVICER; dhe me aplikant

per certifikate "NOVARTIS

PHARMA AG" ZVICER

Riregj.

385/ 17.06.2013

850

Page 201

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202

1501

NITRODERM TTS

10

Transdermal

therapeutic system

x 10mg/24 hour

(50mg/20cm²)

NITROGLYCERIN

Box x 10

transdermal

patches

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

167/19.04.2012

9.33

1502

RASILEZFilm coated -

tablets x 150mg

ALISKIREN (as ALISKIREN

HEMIFUMARATE x

165.75mg)

Box x 28NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS FARMA SPA -

ITALI; (APL: NOVARTIS

PHARMA AG - ZVICER)

RIREGJ.

266/19.04.2013

13.38

1503

RASILEZFilm coated -

tablets x 300mg

ALISKIREN (as ALISKIREN

HEMIFUMARATE x

331.5mg)

Box x 28NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS FARMA SPA -

ITALI; (APL: NOVARTIS

PHARMA AG - ZVICER)

RIREGJ.

266/19.04.2013

27.2

1504

SANDIMMUN

NEORAL 50MGCapsules x 50mg CYCLOSPORINE Box x 50

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

R.P. SCHERER GMBH & CO.

KG - GJERMANI; CATALENT

PHARMA SOLUTIONS LLC -

SHBA (APL: NOVARTIS

PHARMA AG - ZVICËR)

RIREGJ.

148/09.03.2010

38.95

1505

SANDOSTATIN

Solution for

injection x

0.5mg/ml

OCTREOTIDE x 500µg/mlBox x 5

ampoules x 1ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

155/20.04.2011

233.33

1506

SANDOSTATIN

Solution for

injection x

0.05mg/ml

OCTREOTIDE x 50µg/mlBox x 5

ampoules x 1ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

155/20.04.2011

26

1507

SANDOSTATIN

Solution for

injection x

0.1mg/ml

OCTREOTIDE x 100µg/mlBox x 5

ampoules x 1ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

155/20.04.2011

52.67

1508

STALEVO

100/25/200MG

Film coated tablets

x (100mg + 25mg +

200mg)

LEVODOPA + CARBIDOPA

+ ENTACAPONEBox x 30

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

ORION CORPORATION,

ORION PHARMA -

FINLANDË, QUINTA -

ANALYTICA SRO -

REPUBLIKA CEKE (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

78/11.02.2010

34.09

Page 202

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203

1509

STALEVO

50/12.5/200MG

Film coated tablets

x (50mg + 12.5mg

+ 200mg)

LEVODOPA + CARBIDOPA

+ ENTACAPONEBox x 30

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

ORION CORPORATION,

ORION PHARMA -

FINLANDË, QUINTA -

ANALYTICA SRO -

REPUBLIKA CEKE (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

78/11.02.2010

30.68

1510

STALEVO

150/37.5/200MG

Film coated tablets

x (150mg + 37.5mg

+ 200mg)

LEVODOPA + CARBIDOPA

+ ENTACAPONEBox x 30

NOVARTIS PHARMA

SCHWEIZ AG - ZVICËR

ORION CORPORATION,

ORION PHARMA -

FINLANDË, QUINTA -

ANALYTICA SRO -

REPUBLIKA CEKE (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

78/11.02.2010

37.5

1511

TRILEPTALOral suspension x

60mg/mlOXCARBAZEPINE

Box x 1 bottle x

250ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA SAS -

FRANCE (APL: NOVARTIS

PHARMA AG - ZVICER)

RIREGJ.

260/12.06.2012

7.89

1512

TRILEPTALFilm - coated

tablets x 300mgOXCARBAZEPINE Box x 50

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER; NOVARTIS

FARMA SPA - ITALI; (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

266/19.04.2013

12.6

1513

VOLTAREN

Solution for

injection and

infusion x

75mg/3ml

DICLOFENAC SODIUMBox x 5

ampoules x 3ml

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

166/19.04.2012

4.27

1514

VOLTARENEnteric-coated

tablets x 25mgDICLOFENAC SODIUM Box x 10

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, NOVARTIS

FARMA SPA - ITALI (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

190/27.04.2012

1.26

1515

VOLTARENSuppositories x

100mgDICLOFENAC SODIUM Box x 5

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, DELPHARM

HUNINGUE SAS - FRANCE

(APL: NOVARTIS PHARMA

AG - ZVICER)

RIREGJ.

166/19.04.2012

2.8

Page 203

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204

1516

VOLTAREN SRSugar-coated

tablets x 75mgDICLOFENAC SODIUM

Box x 100 (for

hospital use)

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, NOVARTIS

FARMA SPA - ITALI (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

166/19.04.2012

15

1517

VOLTAREN SRSugar-coated

tablets x 75mgDICLOFENAC SODIUM Box x 30

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, NOVARTIS

FARMA SPA - ITALI (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

166/19.04.2012

4.5

1518 XOLAIR

Powder and

solvent for solution

for injection x

150mg/2ml OMALIZUMAB

Box x 1 vial (

powder) + 1

ampoule

(solvent)

"NOVARTIS PHARMA

SCHWEIZ AG" ZVICER

"NOVARTIS PHARMA STEIN

AG" ZVICER; "NYCOMED

AUSTRIA GMBH" AUSTRI

dhe me aplikant per certifikate

"NOVARTIS PHARMA AG"

ZVICER

Riregj.

385/ 17.06.2013

369.6

1519

ZOMETA

Concentrate for

solution for infusion

x 4mg/5ml

ZOLEDRONIC ACID Box x 1 vialNOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER, (APL:

NOVARTIS PHARMA AG -

ZVICER)

RIREGJ.

450/31.10.2011

227

1520

SEEBRI

BREEZHALER

Inhalation powder,

hard capsules x

50µg (44µg/

delivered dose)

GLYCOPYRRONIUM (as

GLYCOPYRRONIUM

BROMIDE)

Box x 30 hard

capsules + 1

inhaler

"NOVARTIS

EUROPHARM LIMITED"

MBRETERI E BASHKUAR

"NOVARTIS PHARMA STEIN

AG" ZVICER; "KONAPHARMA

AG" ZVICER

Regj.451/13.08.2013

31.2

1521

TOBI PODHALER

Inhalation powder,

hard capsules x

28mg

TOBRAMYCIN

Box x 56

capsules + 1

inhaler

"NOVARTIS

EUROPHARM LIMITED"

MBRETERI E BASHKUAR

"NOVARTIS

PHARMACEUTICALS

CORPORATION" SHBA

Regj.

359/28.05.2013

507.92

1522

HALSETTablets (lozenges)

x 1.5mg

CETYLPYRIDINIUM

CHLORIDE

(MONOHYDRATE)

Box x 24

NOVARTIS CONSUMER

HEALTH - GEBRO GMBH -

AUSTRI

NOVARTIS CONSUMER

HEALTH - GEBRO GMBH -

AUSTRI

RIREGJ.

447/03.08.2010

1.5

1523

HOVA

Film coated tablets

x (200.2mg +

45.5mg)

VALERIANAE RADIX

(EXTRACT) + HOP

STROBILE (EXTRACT)

Box x 30

NOVARTIS CONSUMER

HEALTH - GEBRO GMBH -

AUSTRI

NOVARTIS CONSUMER

HEALTH - GEBRO GMBH -

AUSTRI

RIREGJ.

447/03.08.2010

3.2

1524SERACTIL

Film-coated tablets

x 200mgDEXIBUPROFEN Box x 30

GEBRO PHARMA GMBH -

AUSTRI

GEBRO PHARMA GMBH -

AUSTRI

RIREGJ.

584/29.10.2010 2.7

Page 204

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205

1525NORAPRIL Tablets x 2.5mg RAMIPRIL Box x 28 "CIPROS SRL" ITALI

"SPECIAL PRODUCT'S SPA"

ITALIRegj.422/11.07.2013

3.3

1526NORAPRIL Tablets x 5mg RAMIPRIL Box x 14 "CIPROS SRL" ITALI

"SPECIAL PRODUCT'S SPA"

ITALIRegj.422/11.07.2013

3.3

1527NORAPRIL Tablets x 10mg RAMIPRIL Box x 28 "CIPROS SRL" ITALI

"SPECIAL PRODUCT'S SPA"

ITALIRegj.422/11.07.2013

9

1528

DIFOSFON-SFilm-coated tablets

x 35mg

RISEDRONATE SODIUM (as

RISEDRONATE SODIUM

HEMIPENTAHYDRATE x

40.17mg)

Box x 4S.J.A PHARMA LTD -

GREQI

PHARMATHEN SA - GREQI,

PHARMANEL

PHARMACEUTICALS SA -

GREQI, FAMAR SA - GREQI

REGJ.

419/12.10.2011

11

1529

MAXARTANFilm-coated tablets

x (50mg + 12.5mg)

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDEBox x 28

S.J.A PHARMA LTD -

GREQIPHARMATHEN SA - GREQI

REGJ.

419/12.10.2011

5.5

1530

MAXARTANFilm-coated tablets

x (100mg + 25mg)

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDEBox x 28

S.J.A PHARMA LTD -

GREQIPHARMATHEN SA - GREQI

REGJ.

419/12.10.2011

5.05

1531

BRONCHOBOS Syrup x 2.5 % CARBOCISTEINEBox x 1 Bottle x

200 ml

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

REGJ. 42/28.01.2009

2.55

1532

BRONCHOBOS Syrup x 5 % CARBOCISTEINEBox x 1 Bottle x

200 ml

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

REGJ. 42/28.01.2009

2.9

1533

ENTEROFURYL Capsules x 200mg NIFUROXAZIDE Box x 8

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY,

JOINT STOCK COMPANY

- BOSNJE DHE

HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY,

JOINT STOCK COMPANY -

BOSNJE DHE

HERCEGOVINE

REGJ.

286/11.05.2009

1.2

Page 205

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206

1534

FAVISTAN Tablets x 20mg THIAMAZOLE Box x 20

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

RIREGJ.

71/09.02.2010

1.6

1535

GENTAMICIN Ointment x 0.1%

GENTAMICIN (AS

GENTAMICIN SULPHATE x

1.69mg/g)

Box x 1 tube x

15g

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

REGJ.

222/08.04.2009

1.55

1536

KAMFART

Cream x (20mg +

10mg + 10mg +

10mg)/1g

CAMPHOR RACEMIC +

METHYL SALICYLATE +

BENZYL NICOTINATE +

MENTHOL RACEMIC

Box x 1 tube x

40g

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

RIREGJ.

734/28.12.2009

2.3

1537

LOPRIL HTablets x (10mg +

12.5mg)

LISINOPRIL (as LISINOPRIL

DIHYDRATE x 10.888mg) +

HYDROCHLOROTHIAZIDE

Box x 20

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

RIREGJ.

636/13.11.2008

2.91

1538

LOPRIL HTablets x (20mg +

12.5mg)

LISINOPRIL (as LISINOPRIL

DIHYDRATE x 21.776mg) +

HYDROCHLOROTHIAZIDE

Box x 20

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

RIREGJ.

636/13.11.2008

3.89

1539

LYSOBACTOribletes x (20mg

+ 10mg)

LYSOZIME CHLORIDE +

PYRIDOXINE

HYDROCHLORIDE

Box x 30

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

RIREGJ.

300/12.05.2010

1.5

1540

RHINOSTOPTablets x (251mg +

61.2mg + 2.54mg)

PARACETAMOL +

PSEUDOEPHEDRINE

HYDROCHLORIDE +

CHLORPHENAMINE

MALEATE

Box x 20

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

RIREGJ.

632/19.11.2009

2.25

1541

RHINOSTOP

Syrup x (101mg +

20.20mg +

1.01mg)/5ml

PARACETAMOL +

PSEUDOEPHEDRINE

HYDROCHLORIDE +

CHLORPHENAMINE

MALEATE

Box x 1 glass

bottle x 100ml

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

RIREGJ.

734/28.12.2009

2.1

Page 206

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207

1542

LOFOCINFilm coated tablets

x 250 mg

LEVOFLOXACIN (as

LEVOFLOXACIN

HEMIHYDRATE 256.23MG)

Box x 10"PHARMANOVA D.O.O."

SERBI

"INDOCO REMEDIES LTD"

INDI; "JUBILANT LIFE

SCIENCES LTD" INDI";

"PHARMANOVA D.O.O."

SERBI

Regj.422/11.07.2013

6

1543

LOFOCINFilm coated tablets

x 500 mg

LEVOFLOXACIN (as

LEVOFLOXACIN

HEMIHYDRATE 512.46mg)

Box x 10"PHARMANOVA D.O.O."

SERBI

"INDOCO REMEDIES LTD"

INDI; "JUBILANT LIFE

SCIENCES LTD" INDI";

"PHARMANOVA D.O.O."

SERBI

Regj.422/11.07.2013

10

1544

GASTROLOCGastro-resistant

tablets x 20mg

PANTOPRAZOLE (AS

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

22.614mg)

Box x 14;"PHARMANOVA D.O.O."

SERBI

"EMCURE

PHARMACEUTICAL LTD"

INDI; " JUBILANT LIFE

SCIENCES LTD" INDI";

"PHARMANOVA D.O.O."

SERBI

Regj.422/11.07.2013

5

1545

GASTROLOCGastro-resistant

tablets x 40mg

PANTOPRAZOLE (AS

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.228mg)

Box x 14"PHARMANOVA D.O.O."

SERBI

"EMCURE

PHARMACEUTICAL LTD"

INDI; "JUBILANT LIFE

SCIENCES LTD" INDI";

"PHARMANOVA D.O.O."

SERBI

Regj.422/11.07.2013

7

1546

GASTROLOCGastro-resistant

tablets x 20mg

PANTOPRAZOLE (AS

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

22.614mg)

Box x 28"PHARMANOVA D.O.O."

SERBI

"EMCURE

PHARMACEUTICAL LTD"

INDI; " JUBILANT LIFE

SCIENCES LTD" INDI";

"PHARMANOVA D.O.O."

SERBI

Regj.422/11.07.2013

7

1547

GASTROLOCGastro-resistant

tablets x 40mg

PANTOPRAZOLE (AS

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.228mg)

Box x 28"PHARMANOVA D.O.O."

SERBI

"EMCURE

PHARMACEUTICAL LTD"

INDI; "JUBILANT LIFE

SCIENCES LTD" INDI";

"PHARMANOVA D.O.O."

SERBI

Regj.422/11.07.2013

10

1548

DAKIN COOPER

STABILISE

Solution for local

aplication x

0.5g/100ml

CONCENTRATED

SOLUTION OF SODIUM

HYPOCHLORIDE

(CORRESPONDING TO

ACTIVE CHLORINE x 0.5G)

Flacon x 250ml;

COOPERATION

PHARMACEUTIQUE

FRANCAISE - FRANCE

COOPERATION

PHARMACEUTIQUE

FRANCAISE - FRANCE

REGJ.

285/11.05.2009

2.2

Page 207

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208

1549

MIRTAZAPINE Film-coated tablets

x 30mgMIRTAZAPINE Box x 28

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

11.2

1550

MIRTAZAPINE Film-coated tablets

x 45mgMIRTAZAPINE Box x 28

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR

AUROBINDO PHARMA

LIMITED - MBRETERI E

BASHKUAR; AUROBINDO

PHARMA LIMITED - INDI

REGJ.

564/27.10.2009

13.4

1551

GEMZAR

Powder for solution

for infusion x

200mg

GEMCITABINE (in form of

GEMCITABINE

HYDROCHLORIDE x

228mg)

Box x 1 vial LILLY FRANCE - FRANCE

LILLY FRANCE - FRANCE;

ELI LILLY AND COMPANY -

SHBA

RIREGJ.

348/05.06.2009

15.4

1552

GEMZAR

Powder for solution

for infusion x

1000mg

GEMCITABINE (in form of

GEMCITABINE

HYDROCHLORIDE x

1140mg)

Box x 1 vial LILLY FRANCE - FRANCE

LILLY FRANCE - FRANCE;

ELI LILLY AND COMPANY -

SHBA

RIREGJ.

348/05.06.2009

66.18

1553

ALIMTA

Powder for

concentrate for

solution for infusion

x 500mg/vial

PEMETREXED Box x 1 vialELI LILLY NETHERLAND

BV - HOLLANDE

ELI LILLY AND COMPANY -

SHBA; LILLY FRANCE -

FRANCE

RIREGJ

62/06.02.2013

1380

1554

CIALISFilm coated tablets

x 10mgTADALAFIL Box x 4

ELI LILLY NEDERLAND

BV - HOLLANDE

LILLY SA - SPANJE

(APLIKANT: LILLY SA -

SPANJE)

RIREGJ.

43/28.01.200932.77

1555

CIALISFilm coated tablets

x 20mgTADALAFIL Box x 4,

ELI LILLY NEDERLAND

BV - HOLLANDE

LILLY SA - SPANJE

(APLIKANT: LILLY SA -

SPANJE)

RIREGJ.

43/28.01.200932.77

1556

CIALISFilm coated tablets

x 20mgTADALAFIL Box x 2,

ELI LILLY NEDERLAND

BV - HOLLANDE

LILLY SA - SPANJE

(APLIKANT: LILLY SA -

SPANJE)

RIREGJ.

43/28.01.200916.38

1557

MIFEGYNE Tablets x 200mg MIFEPRISTONE Box x 3 "EXELGYN" FRANCE

"LABORATOIRES MACORS"

FRNCE dhe me aplikant per

çertifikate "NORDIC PHARMA"

FRANCE

Regj.422/11.07.2013

44.14

Page 208

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209

1558

ACTEMRA

Concentrate for

solution for infusion

x 400mg/20ml

TOCILIZUMAB Box x 1 vial,ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CHUGAI PHARMA

MANUFACTURING CO. LTD -

JAPONI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.-

ZVICER)

REGJ.

428/04.08.2009

648

1559

ACTEMRA

Concentrate for

solution for infusion

x 400mg/20ml

TOCILIZUMAB Box x 4 vialsROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CHUGAI PHARMA

MANUFACTURING CO. LTD -

JAPONI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.-

ZVICER)

REGJ.

428/04.08.2009

2592

1560

ACTEMRA

Concentrate for

solution for infusion

x 80mg/4ml

TOCILIZUMAB Box x 1 vialROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CHUGAI PHARMA

MANUFACTURING CO. LTD -

JAPONI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.-

ZVICER)

REGJ.

428/04.08.2009

130

1561

ACTEMRA

Concentrate for

solution for infusion

x 80mg/4ml

TOCILIZUMAB Box x 4 vialsROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CHUGAI PHARMA

MANUFACTURING CO. LTD -

JAPONI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.-

ZVICER)

REGJ.

428/04.08.2009

520

1562

ACTEMRA

Concentrate for

solution for infusion

x 200mg/10ml

TOCILIZUMAB Box x 1 vial, ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CHUGAI PHARMA

MANUFACTURING CO. LTD -

JAPONI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.-

ZVICER)

REGJ.

428/04.08.2009

330

1563

ACTEMRA

Concentrate for

solution for infusion

x 200mg/10ml

TOCILIZUMAB Box x 4 vialsROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CHUGAI PHARMA

MANUFACTURING CO. LTD -

JAPONI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.-

ZVICER)

REGJ.

428/04.08.2009

1280

Page 209

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210

1564

AVASTIN

Concentrate for

solution for infusion

x 25mg/ml

BEVACIZUMABBox x 1vial x

4ml

ROCHE REGISTRATION

LTD. - MBRETËRI E

BASHKUAR

GENENTECH INC. - SHBA; F.

HOFFMANN-LA ROCHE

LTD., BAZEL - ZVICËR;

ROCHE DIAGNOSTICS

GMBH - GJERMANI

RIREGJ.

489/10.09.2010

296.9

1565

AVASTIN

Concentrate for

solution for infusion

x 25mg/ml

BEVACIZUMABBox x 1vial x

16ml

ROCHE REGISTRATION

LTD. - MBRETËRI E

BASHKUAR

GENENTECH INC. - SHBA; F.

HOFFMANN-LA ROCHE

LTD., BAZEL - ZVICËR;

ROCHE DIAGNOSTICS

GMBH - GJERMANI

RIREGJ.

489/10.09.2010

1100

1566

BACTRIM FORTETablets x (800mg +

160mg)

SULFAMETHOXAZOLE +

TRIMETHOPRIMBox x 10

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

PRODUCTOS ROCHE S.A

DE C.V - MEKSIKE; (APL: F.

HOFFMANN-LA ROCHE LTD -

ZVICER)

REGJ.

307/07.05.2013

1.4

1567

BONVIVAFilm-coated tablets

x 150mgIBANDRONIC ACID Box x 1

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER (APL:

F.HOFFMANN-LA ROCHE

LTD - ZVICER)

REGJ.

118/15.03.2012

13.9

1568

BONVIVA Solution for

injection x 3mg/3ml

IBANDRONIC ACID (as

IBANDRONIC ACID, MONO-

SODIUM SALT

MONOHYDRATE x

3.375mg/3ml)

Box x 1 pre-

filled syringe

ROCHE REGISTRATION

LTD - MBRETERI E

BASHKUAR

VETTER PHARMA -

FERTIGUNG GMBH & CO.KG

- GJERMANI

RIREGJ.

109/01.03.2013

47.78

1569

COPEGUS Film coated tablets

x 200mgRIBAVIRIN

Box x 1 flacon x

42

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

HOFFMANN-LA ROCHE INC. -

SHBA; PATHEON INC. -

KANADA; (APL:

F.HOFFMANN-LA ROCHE

LTD. - ZVICER

RIREGJ.

182/18.03.2009

62.5

1570

COPEGUS Film coated tablets

x 200mgRIBAVIRIN

Box x 1 flacon x

168 (for hospital

use only)

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

HOFFMANN-LA ROCHE INC. -

SHBA; PATHEON INC. -

KANADA; (APL:

F.HOFFMANN-LA ROCHE

LTD. - ZVICER

RIREGJ.

182/18.03.2009

250

Page 210

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211

1571

HERCEPTIN

Powder for

concentrate for

solution for infusion

x 150 mg

TRASTUZUMABBox x 1 vial of

powder

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F. HOFFMANN-LA ROCHE

LTD - ZVICER; ROCHE

DIAGNOSTICS GMBH -

GJERMANI; (APL: F.

HOFFMANN-LA ROCHE LTD -

ZVICER

RIREGJ.

182/18.03.2009

520

1572

KYTRIL

Concentrate for

solution for infusion

x 1mg/1ml

GRANISETRON (as

GRANISETRON

HYDROCHLORIDE)

Box x 5

ampoules x 1ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CENEXI S.A.S. - FRANCE

(APL: F. HOFFMANN-LA

ROCHE LTD. - ZVICER)

REGJ. 24/13.01.2011

26.9

1573

KYTRIL

Concentrate for

solution for infusion

x 3mg/3ml

GRANISETRON (as

GRANISETRON

HYDROCHLORIDE)

Box x 5

ampoules x 3ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

CENEXI S.A.S. - FRANCE

(APL: F. HOFFMANN-LA

ROCHE LTD. - ZVICER)

REGJ. 24/13.01.2011

59

1574

KYTRILFilm-coated tablets

x 1mgGRANISETRON Box x 10

ROCHE PHARMA

(SCHWEIZ) LTD. -

ZVICËR

ROCHE SPA SEGRATE -

ITALI (APL: F. HOFFMANN-

LA ROCHE LTD. - ZVICËR)

RIREGJ.

447/03.08.2010

29

1575

MABTHERA

Concentrate for

infusion x

10mg/1ml

RITUXIMABBox x 2 vials x

10ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER; GENENTECH

INC - SHBA; ROCHE

DIAGNOSTICS GMBH, -

GJERMANI (APLIKANT PER

CERTIFIKATE: F.HOFFMANN-

LA ROCHE LTD - ZVICER)

Riregj.

385/ 17.06.2013

430

1576

MABTHERA

Concentrate for

infusion x

10mg/1ml

RITUXIMABBox x 1 vial x

50ml,

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER; GENENTECH

INC - SHBA; ROCHE

DIAGNOSTICS GMBH, -

GJERMANI (APLIKANT PER

CERTIFIKATE: F.HOFFMANN-

LA ROCHE LTD - ZVICER)

Riregj.

385/ 17.06.2013

1135

Page 211

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212

1577

MADOPARDispersible tablets

x (100mg + 25mg)

LEVODOPA +

BENSERAZIDE (as

BENSERAZIDE

HYDROCHLORIDE X

28.5MG)

Box x 1 glass

bottle x 100

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

ROCHE (SEGRATE) SPA -

ITALI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD -

ZVICER)

RIREGJ.

570/24.10.2008

9.5

1578

MIRCERA

Solution for

injection x 250mcg

/ 0.3ml

METHOXY POLYETHYLENE

GLYCOL-EPOETIN BETA

Box x 1 pre-

filled syringe

0.3ml + 1

Injection needle

ROCHE REGISTRATION

LTD - MBRETERIA E

BASHKUAR

ROCHE DIAGNOSTICS

GMBH - GJERMANI

Riregj.

385/ 17.06.2013

290

1579

MIRCERA

Solution for

injection x 360µg /

0.6ml

METHOXY POLYETHYLENE

GLYCOL-EPOETIN BETA

Box x 1 pre-

filled syringe x

0.6ml

ROCHE REGISTRATION

LTD - MBRETERI E

BASHKUAR

ROCHE DIAGNOSTICS

GMBH - GJERMANI

REGJ.

480/11.09.2009

631.03

1580

RECORMONSol. for injection x

2000 IU / 0.3mlEPOETIN BETA

Box x 6 pre-

filled syringe + 6

needles

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER; ROCHE

DIAGNOSTICS GMBH -

GJERMANI; VETTER

PHARMA-FERTIGUNG GMBH

& CO.KG - GJERMANI;

(APLIKANT PER

CERTIFIKATE: F.HOFFMANN-

LA ROCHE LTD - ZVICER)

Riregj.

385/ 17.06.2013

50.53

1581

RECORMON PS

30 000

Solution for

injection x 30 000

IU/0.6ml

EPOETIN BETA

Box x 4 pre-

filled syringes x

0.6ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

ROCHE DIAGNOSTICS

GMBH - GJERMANI; F.

HOFFMANN-LA ROCHE LTD -

ZVICER (APL: F. HOFFMANN-

LA ROCHE LTD - ZVICER)

RIREGJ.

46/30.01.2012

600

1582

PEGASYS

Solution for

injection x

135μg/0.5ml in pre-

filled syringes

PEGINTERFERON alfa-2aBox x 1 pre-

filled syringe

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE

DIAGNOSTICS GMBH -

GJERMANI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.

- ZVICËR)

RIREGJ.

392/01.07.2009

135

Page 212

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213

1583

PEGASYS

Solution for

injection x

135μg/0.5ml in pre-

filled syringes

PEGINTERFERON alfa-2a

Box x 1 pre-

filled syringe,

Box x 4 pre-

filled syringes

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE

DIAGNOSTICS GMBH -

GJERMANI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.

- ZVICËR)

RIREGJ.

392/01.07.2009

530

1584

PEGASYS

Solution for

injection x

180μg/0.5ml in pre-

filled syringes

PEGINTERFERON alfa-2aBox x 1 pre-

filled syringe

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE

DIAGNOSTICS GMBH -

GJERMANI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.

- ZVICËR)

RIREGJ.

392/01.07.2009

164.5

1585

PEGASYS

Solution for

injection x

180μg/0.5ml in pre-

filled syringes

PEGINTERFERON alfa-2a Box x 4 pre-

filled syringes

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE

DIAGNOSTICS GMBH -

GJERMANI (APLIKANT: F.

HOFFMANN-LA ROCHE LTD.

- ZVICËR)

RIREGJ.

392/01.07.2009

640

1586

ROACCUTANE Capsules x 10mg ISOTRETINOIN Box x 30ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

R.P. SCHERER GMBH & CO.

KG - GJERMANI (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD - ZVICER)

RIREGJ.

636/13.11.2008

11.01

1587

ROACCUTANE Capsules x 20mg ISOTRETINOIN Box x 30ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

R.P. SCHERER GMBH & CO.

KG - GJERMANI (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD - ZVICER)

RIREGJ.

636/13.11.2008

22.02

1588

ROCALTROLCapsules x

0.25mcgCALCITRIOL Box x 30

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

R.P. SCHERER GMBH & CO.

KG - GJERMANI (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD - ZVICER)

Riregj.

385/ 17.06.2013

4

Page 213

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214

1589

ROCALTROLCapsules x

0.25mcgCALCITRIOL

(Box x 100 for

hospital use

only)

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

R.P. SCHERER GMBH & CO.

KG - GJERMANI (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD - ZVICER)

Riregj.

385/ 17.06.2013

12

1590

ROCALTROL Capsules x 0.5mcg CALCITRIOL Box x 30ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

R.P. SCHERER GMBH & CO.

KG - GJERMANI (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD - ZVICER)

Riregj.

385/ 17.06.2013

7

1591

ROCALTROL Capsules x 0.5mcg CALCITRIOL

(Box x 100 for

hospital use

only)

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

R.P. SCHERER GMBH & CO.

KG - GJERMANI (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD - ZVICER)

Riregj.

385/ 17.06.2013

23

1592

ROCEPHIN

Powder for solution

for I.V. injection x

2g/vial

CEFTRIAXONE (as

CEFTRIAXONE DISODIUM x

3.5H2O x 2.386g)

Box x 1 vialROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F. HOFFMANN-LA ROCHE

LTD. - ZVICER, (APLIKANT:

F. HOFFMANN-LA ROCHE

LTD. - ZVICER)

REGJ.

530/14.10.2009

8.51

1593

ROCEPHIN

Powder for solution

for I.V. injection x

1g/vial

CEFTRIAXONE

Box x (1 vial

with powder + 1

ampoule with

solvent x 10ml)

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER; CENEXI SAS -

FRANCE (APL: F.HOFFMANN-

LA ROCHE LTD - ZVICER)

RIREGJ.

109/01.03.2013

4.69

1594

ROFERON-A

Solution for

injection x 4.5

Mio.I.E.

(MIU)/0.5ml

INTERFERON ALFA-2A

Box x 1 pre-

filled syringe for

single-dose, s.c.

injection + 1

needle

ROCHE PHARMA AG -

GJERMANI

F.HOFFMANN-LA ROCHE AG

- ZVICER

RIREGJ.

333/29.08.2011

20.13

1595

ROFERON-A

Solution for

injection x 18 MIO

IE/0.6ml

INTERFERON ALFA-2A (18

MIU/0.6ML)

Box x 1

multidose

cartridge of

0.6ml

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

VETTER PHARMA-

FERTIGUNG GMBH & CO.KG

- GJERMANI (APL: F.

HOFFMANN-LA ROCHE LTD -

ZVICER)

REGJ.

377/19.06.2009

80.51

1596

TAMIFLUHard capsules x

30mgOSELTAMIVIR Box x 10

ROCHE REGISTRATION

LTD - MBRETERIA E

BASHKUAR

F. HOFFMANN-LA ROCHE

LTD - ZVICER, ROCHE SPA

SEGRATE - ITALI

REGJ.

619/05.11.2008

7.6

Page 214

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215

1597

TAMIFLUHard capsules x

45mgOSELTAMIVIR Box x 10

ROCHE REGISTRATION

LTD - MBRETERIA E

BASHKUAR

F. HOFFMANN-LA ROCHE

LTD - ZVICER, ROCHE SPA

SEGRATE - ITALI

REGJ.

619/05.11.2008

12.03

1598

TAMIFLUHard capsules x

75mg

OSELTAMIVIR EQ. TO

98.5mg OSELTAMIVIR

PHOSPHAT

Box x 10

ROCHE PHARMA

(SCHWEIZ) LTD. -

ZVICËR

F.HOFFMANN-LA ROCHE

LTD - ZVICËR; CENEXI S.A.S.

- FRANCË; CATALENT

GERMANY SCHORNDORF

GMBH - GJERMANI; ROCHE

SPA - ITALI (APL: F.

HOFFMANN-LA ROCHE LTD.

- ZVICER)

RIREGJ.

75/01.03.2011

12.94

1599

TARCEVAFilm-coated tablets

x 25mgERLOTINIB Box x 30

ROCHE PHARMA

(SCHWEIZ) LTD. -

ZVICËR

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE SPA -

ITALI (APL: F. HOFFMANN-

LA ROCHE LTD. - ZVICËR)

RIREGJ.

516/24.09.2010

432

1600

TARCEVAFilm-coated tablets

x 100mgERLOTINIB Box x 30

ROCHE PHARMA

(SCHWEIZ) LTD. -

ZVICËR

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE SPA -

ITALI (APL: F. HOFFMANN-

LA ROCHE LTD. - ZVICËR)

RIREGJ.

516/24.09.2010

1400

1601

TARCEVAFilm-coated tablets

x 150mgERLOTINIB Box x 30

ROCHE PHARMA

(SCHWEIZ) LTD. -

ZVICËR

F. HOFFMANN-LA ROCHE

LTD. - ZVICËR, ROCHE SPA -

ITALI (APL: F. HOFFMANN-

LA ROCHE LTD. - ZVICËR)

RIREGJ.

516/24.09.2010

1770

1602

XELODAFilm coated tablets

x 150mgCAPECITABIN Box x 60

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

PRODUCTOS ROCHE SA de

C.V. - MEKSIKE; SYNTEX SA

de C.V. - MEKSIKE; (aplikant

per certifikate) F.HOFFMAN-

LA ROCHE LTD - ZVICER

Riregj.

385/ 17.06.2013

39

Page 215

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216

1603

XELODAFilm coated tablets

x 500mgCAPECITABIN Box x 120

ROCHE PHARMA

(SCHWEIZ) LTD - ZVICER

PRODUCTOS ROCHE SA de

C.V. - MEKSIKE; SYNTEX SA

de C.V. - MEKSIKE; (aplikant

per certifikate) F.HOFFMAN-

LA ROCHE LTD - ZVICER

Riregj.

385/ 17.06.2013

250

1604

XENICAL Capsules x 120mg ORLISTAT Box x 42

ROCHE

PHARMA(SCHWEIZ) LTD -

ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER; HOFFMANN-

LA ROCHE INC. - SHBA;

ROCHE (SEGRATE) SPA -

ITALI (APLIKANT:

F.HOFFMANN-LA ROCHE

LTD - ZVICER)

Riregj.

385/ 17.06.2013

21

1605

XENICAL Capsules x 120mg ORLISTAT Box x 84

ROCHE

PHARMA(SCHWEIZ) LTD -

ZVICER

F.HOFFMANN-LA ROCHE

LTD - ZVICER; HOFFMANN-

LA ROCHE INC. - SHBA;

ROCHE (SEGRATE) SPA -

ITALI (APLIKANT:

F.HOFFMANN-LA ROCHE

LTD - ZVICER)

Riregj.

385/ 17.06.2013

40

1606

CARBOPLATIN

"EBEWE"

Concentrate for

solution for infusion

x 10mg/1ml

CARBOPLATIN Box x 1 vial x

5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

15

1607

CARBOPLATIN

"EBEWE"

Concentrate for

solution for infusion

x 10mg/1ml

CARBOPLATIN Box x 1 vial x

15ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

28

1608

CARBOPLATIN

"EBEWE"

Concentrate for

solution for infusion

x 10mg/1ml

CARBOPLATIN Box x 1 vial x

45ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

67

1609

CISPLATIN

"EBEWE"

Concentrate for

solution for infusion

x 0.5mg/1ml

CISPLATINBox x 1 vial x

50ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

11

Page 216

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217

1610

CISPLATIN

"EBEWE"

Concentrate for

solution for infusion

x 0.5mg/1ml

CISPLATIN Box x 1 vial x

100ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

17.1

1611

CISPLATIN

"EBEWE"

Concentrate for

solution for infusion

x 1mg/1ml

CISPLATINBox x 1 vial x

100ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

20

1612

DOXORUBICIN

"EBEWE"

Concentrate for

solution for infusion

x 2mg/1ml

DOXORUBICIN

HYDROCHLORIDE

Box x 1 vial x

5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

6.1

1613

DOXORUBICIN

"EBEWE"

Concentrate for

solution for infusion

x 2mg/1ml

DOXORUBICIN

HYDROCHLORIDE

Box x 1 vial x

25ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

22.5

1614

EPIRUBICIN

"EBEWE"

Concentrate for

solution for infusion

x 2mg/1ml

EPIRUBICIN

HYDROCHLORIDE

Box x 1 vial x

5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

12

1615

EPIRUBICIN

"EBEWE"

Concentrate for

solution for infusion

x 2mg/1ml

EPIRUBICIN

HYDROCHLORIDE

Box x 1 vial x

25ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

30

1616

EPIRUBICIN

"EBEWE"

Concentrate for

solution for infusion

x 2mg/1ml

EPIRUBICIN

HYDROCHLORIDE

Box x 1 vial x

50ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

55

1617

ETOPOSID

"EBEWE"

Concentrate for

solution for infusion

x 20mg/1ml

ETOPOSIDEBox x 1 vial x

2.5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

6.7

1618

ETOPOSID

"EBEWE"

Concentrate for

solution for infusion

x 20mg/1ml

ETOPOSIDE Box x 1 vial x

5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

9.8

1619

ETOPOSID

"EBEWE"

Concentrate for

solution for infusion

x 20mg/1ml

ETOPOSIDEBox x 1 vial x

10ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

18

Page 217

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218

1620

FLUDARABIN

"EBEWE"

Concentrate for

solution for

injection/infusion x

50mg/2ml

FLUDARABINE

PHOSPHATE

Box x 1 vial x

2ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

REGJ.

467/04.09.2009

85

1621

5-

FLUOROURACIL

"EBEWE"

Concentrate for

solution for infusion

x 50mg/1ml

FLUOROURACILBox x 1 vial x

5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

3.9

1622

5-

FLUOROURACIL

"EBEWE"

Concentrate for

solution for infusion

x 50mg/1ml

FLUOROURACIL Box x 1 vial x

10ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

5.6

1623

5-

FLUOROURACIL

"EBEWE"

Concentrate for

solution for infusion

x 50mg/1ml

FLUOROURACILBox x 5

ampoules x 5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

10.2

1624

5-

FLUOROURACIL

"EBEWE"

Concentrate for

solution for infusion

x 50mg/1ml

FLUOROURACIL

Box x 5

ampoules x

10ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.2009

13.6

1625

CALCIUMFOLINA

T "EBEWE"

Solution for

infusion x

10mg/1ml

FOLINIC ACID (as CALCIUM

FOLINATE x 5 H2O x

12.705mg/ml)

Box x 5

ampoules x 3ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.200923

1626

CALCIUMFOLINA

T "EBEWE"

Solution for

infusion x

10mg/1ml

FOLINIC ACID (as CALCIUM

FOLINATE x 5 H2O x

12.705mg/ml)

Box x 5

ampoules x 5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

251/23.04.200950

1627

METHOTREXAT

"EBEWE"

Concentrate for

solution for infusion

x 100mg/ml

METHOTREXATE

Box x 1 vial x

5ml

(500mg/5ml)

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.2010

20

1628

METHOTREXAT

"EBEWE"

Concentrate for

solution for infusion

x 100mg/ml

METHOTREXATE

Box x 1 vial x

10ml

(1000mg/10ml)

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.2010

36

1629

METHOTREXAT

"EBEWE"

Concentrate for

solution for infusion

x 100mg/ml

METHOTREXATE

Box x 1 vial x

50ml

(5000mg/50ml)

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.2010

180

Page 218

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219

1630

METHOTREXAT

"EBEWE"

Solution for

injection/infusion x

10mg/ml

METHOTREXATE

Box x 5

ampoules x 5ml

(50mg/5ml),

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.2010

14.58

1631

METHOTREXAT

"EBEWE"

Solution for

injection/infusion x

10mg/ml

METHOTREXATE Box x 10

ampoules x 1ml

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.201022

1632

METHOTREXAT

"EBEWE"

Solution for

injection/infusion x

10mg/ml

METHOTREXATEBox x vial x 5ml

(50mg/5ml)

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.20103.3

1633

METHOTREXAT

"EBEWE"

Solution for

injection/infusion x

10mg/ml

METHOTREXATE Box x vial x 1ml

(10mg/ml)

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

268/28.04.20102.2

1634

MITOXANTRON

"EBEWE"

Concentrate for

solution for infusion

x 2mg/ml

MITOXANTRONE (as

MITOXANTRONE

DIHYDROCHLORIDE x

2.3284mg/ml)

Box x 1 vial x

5ml

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

734/28.12.2009

55

1635

MITOXANTRON

"EBEWE"

Concentrate for

solution for infusion

x 2mg/ml

MITOXANTRONE (as

MITOXANTRONE

DIHYDROCHLORIDE x

2.3284mg/ml)

Box x 1 vial x

10ml

EBEWE PHARMA

GES.MBH. NFG. KG -

AUSTRI

EBEWE PHARMA GES.MBH.

NFG. KG - AUSTRI

RIREGJ.

734/28.12.2009

100

1636

PACLITAXEL

EBEWE

Concentrate for

solution for infusion

x 6mg/1ml

PACLITAXELBox x 1 vial x

5ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

446/26.08.2009

95

1637

PACLITAXEL

EBEWE

Concentrate for

solution for infusion

x 6mg/1ml

PACLITAXELBox x 1 vial x

16.7ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

446/26.08.2009

80

1638

PACLITAXEL

EBEWE

Concentrate for

solution for infusion

x 6mg/1ml

PACLITAXELBox x 1 vial x

25ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

446/26.08.2009

140

1639

PACLITAXEL

EBEWE

Concentrate for

solution for infusion

x 6mg/1ml

PACLITAXELBox x 1 vial x

50ml

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

EBEWE PHARMA

GES.M.B.H. NFG. KG -

AUSTRI

RIREGJ.

446/26.08.2009

220

Page 219

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220

1640

TAXOCEF

Powder and

solvent for solution

for IM/IV injection x

1g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM

STERILE x 1048mg/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent x 4ml

(water for

injection)

TOPRAK ILAC VE KIMYEI

MAD. SAN. VE TIC. AS -

TURQI

TOPRAK ILAC VE KIMYEI

MAD. SAN. VE TIC. AS -

TURQI

REGJ.

307/07.05.2013

1.2

1641

DEEP RELIEFGel x (5% w/w + 3

% w/w)

IBUPROFEN +

LEVOMENTHOL

Box x 1 tube x

50 g

THE MENTHOLATUM

COMPANY LIMITED -

MBRETERI E BASHKUAR

THE MENTHOLATUM

COMPANY LIMITED -

MBRETERI E BASHKUAR

REGJ. 42/28.01.2009

3.59

1642

DEEP HEAT RUB

Cream x (1.97%

w/w + 1.47% w/w +

5.910% w/w +

12.800% w/w)

EUCALYPTUS OIL +

TURPENTINE OIL +

MENTHOL + METHYL

SALICILATE

Box x 1 tube x

67 g

THE MENTHOLATUM

COMPANY LIMITED -

MBRETERI E BASHKUAR

THE MENTHOLATUM

COMPANY LIMITED -

MBRETERI E BASHKUAR

REGJ. 42/28.01.2009

3.13

1643

BABY LUUF

BALSAM

Balsam x (15mg +

40mg + 10mg)/g

ETHEREAL EUCALYPTUS

OIL + PURIFIED ETHEREAL

TERPENTINE OIL +

ETHEREAL THYME OIL

Box x 1 glass

bottle x 30g

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH -

AUSTRI

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH - AUSTRI

RIREGJ.

190/12.05.2011

2.827

1644

KINDER LUUF

BALSAM

Balsam x (50mg +

27.5mg + 15mg +

50mg + 2.5mg/g

CAMPHOR + MENTHOL +

ETHEREAL EUCALYPTUS

OIL + RECTIFIED

ETHEREAL TERPENTINE

OIL + THYMOL

Box x 1 glass

bottle x 30g

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH -

AUSTRI

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH - AUSTRI

RIREGJ.

190/12.05.2011

2.827

1645

LUUF

Nasal spray,

solution x (1mg +

1mg)/ml

NAPHAZOLINE

HYDROCHLORIDE +

DIPHENHYDRAMINE

HYDROCHLORIDE

Box x 1

polyethylene

spray bottle x

15ml

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH -

AUSTRI

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH - AUSTRI

RIREGJ.

190/12.05.2011

2.7078

1646

DERMABIOLENECream x 0.166g +

0.122g

GENTAMICIN AS

GENTAMICIN SULPHATE +

BETAMETHASONE AS

BETAMETHASONE

VALERATE

Box x tub x 30g

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L. - ITALI

DOPPEL FARMACEUTICI

S.R.L. - ITALI

RIREGJ.

336/20.07.2012

5

Page 220

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221

1647

BETAMETASONE

L.F.M

Solution for

injection x 4mg/ml

BETAMETHASONE (as

BETAMETHASONE

SODIUM PHOSPHATE x

5.263mg/ml)

Box x 3

ampoules x 1ml

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

BIOLOGICI ITALIA

LABORATORIES SRL - ITALI,

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

REGJ.

392/28.08.2012

1.4

1648

FUROSEMIDE

L.F.MTablets x 25mg FUROSEMIDE Box x 30

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

REGJ.

604/27.11.2012

0.9

1649

JODOCURCutaneous solution

x 10g/100ml

POVIDONE IODINE

(corresp. to ACTIVE IODINE

x 1g/100ml)

Box x plastic

bottle x 100ml

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

REGJ.

604/27.11.2012

2

1650

LISANIRCModified release

tablets x 80mgNICARDIPINE Box x 20

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

FINE FOODS &

PHARMACEUTICALS N.T.M

SPA - ITALI; LABORATORIO

ITALIANO BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

RIREGJ.

167/19.04.2012

4

1651

TARGETTablets x (100mg +

25mg)

ATENOLOL +

CHLORTALIDONEBox x 28

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI;

FINE FOOD &

PHARMACEUTICAL SPA -

ITALI; GEYMONAT SPA -

ITALI

RIREGJ.

75/17.02.2012

3.25

1652

MOTICLOD

Solution for

injection x 100

mg/3.3 ml

DISODIUM CLODRONATE

(as DISODIUM

CLODRONATE

TETRAHYDRATE x 125 mg)

Box x 6

ampoules x 3.3

ml

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

REGJ.

684/15.12.2008

5

1653

SPASMEX

Solution for

injection x 51.43

mg/4 ml

PHLOROGLUCINOL

DIHYDRATE

(TRIHYDROXIBENZENE

DIHYDRATE)

Box x 10

ampoules x 4 mlSCHARPER SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI, FISIOPHARMA

SRL - ITALI, BIOLAB SPA -

ITALI

REGJ.

569/24.10.2008

3.1

Page 221

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222

1654

SPASMEXTablets x (102.85

mg + 80 mg)

PHLOROGLUCINOL

DIHYDRATE

(TRIHYDROXIBENZENE

DIHYDRATE) +

TRIMETHYLPHLOROGLUCI

NOL

(TRIMETHOXYBENZENE)

Box x 20 SCHARPER SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI, USIPHAR -

FRANCE

REGJ.

569/24.10.2008

4.8

1655

SOPULMIN Syrup x 40 mg/5 ml SOBREROLBox x 1 flacon x

200 mlSCHARPER SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

684/15.12.20085.2

1656

SOPULMINNebulising solution

x 40 mg/3 mlSOBREROL

Box x 10

ampoules x 3 mlSCHARPER SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

684/15.12.20085

1657

SOPULMINSuppositories x 20

mgSOBREROL Box x 10 SCHARPER SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

684/15.12.20083.9

1658

SOPULMINSuppositories x

100 mgSOBREROL Box x 10 SCHARPER SPA - ITALI

DOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

684/15.12.20084.5

1659

FUREDAN Tablets x 50mg NITROFURANTOIN Box x 15 SCHARPER SPA - ITALIDOPPEL FARMACEUTICI

SRL - ITALI

REGJ.

189/12.05.20114.2

1660RUBOCORD

Cream x

0.0005g/1g

CLOBETASOL

PROPIONATE

Box x 1 tube x

30 gRAFARM SA - GREQI RAFARM SA - GREQI

RIREGJ. 433/2 Dt.

28.09.2012 1.8

1661

VELTIFEROral solution x

100mg/5ml

FERRIC HYDROXIDE

POLYMALTOSE COMPLEX

x 71.4mg/ml equivalent to

IRON (III) x 20mg/ml

Box x 10 single

dose vials x 5mlRAFARMA SA - GREQI RAFARMA SA - GREQI

RIREGJ.

291/06.05.2010

4.6

1662SUCRYL Tablets x 2mg GLIMEPIRIDE Box x 30 RAFARM SA - GREQI RAFARM SA - GREQI

RIREGJ.

325/15.05.2013 2.6

1663SUCRYL Tablets x 4mg GLIMEPIRIDE Box x 30 RAFARM SA - GREQI RAFARM SA - GREQI

RIREGJ.

325/15.05.2013 4.5

1664

MOSMASS Tablets x 70mg

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE x 91.37mg)

Box x 4 RAFARM SA - GREQI RAFARM SA - GREQIREGJ.

646/10.12.2010

8.4

Page 222

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223

1665

TRIMETACORProlonged release

tablets x 35mgTRIMETAZIDINE Box x 60

ALVOGEN IPCo. S.ar.l -

LUKSEMBURG

CEMELOG-BRS LTD -

HUNGARI;

EXTRACTUMPHARMA ZRT -

HUNGARI

REGJ. 74/17.02.2012

6.5

1666QUODIXOR

Film-coated tablets

x 150mgIBANDRONIC ACID Box x 1

ALVOGEN IPCo. S.ar.l -

LUKSEMBURGPHARMATHEN SA - GREQI REGJ. 74/17.02.2012

8

1667

VANCOMYCIN

XELLIA

Powder for solution

for infusion x

500mg/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE)

Box x 1 vial

XELLIA

PHARMACEUTICALS APS

- DANIMARKE

XELLIA PHARMACEUTICALS

APS - DANIMARKEREGJ. 74/17.02.2012

5

1668

VANCOMYCIN

XELLIA

Powder for solution

for infusion x

1000mg/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE)

Box x 1 vial

XELLIA

PHARMACEUTICALS APS

- DANIMARKE

XELLIA PHARMACEUTICALS

APS - DANIMARKEREGJ. 74/17.02.2012

7

1669

EXEMESTANE

ALVOGEN

Film-coated tablets

x 25mgEXEMESTANE Box x 30

ALVOGEN IPCo. S.ar.l -

LUKSEMBURG

EIRGEN PHARMALIMITED -

IRLANDE; SIEGFRIED

GENERICS MALTA LTD -

MALTE

REGJ. 74/17.02.2012

25

1670

DOCETAXEL

HOSPIRA

Concentrate for

solution for infusion

x 80mg/8ml

DOCETAXELBox x 1 glass

vial x 8ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

ZYDUS HOSPIRA

ONCOLOGY PRIVATE

LIMITED - INDI, HOSPIRA UK

LIMITED - MBRETERI E

BASHKUAR

REGJ.

151/05.04.2012

110

1671

NIVESTIM

Solution for

injection/infusion x

120µg/0.2ml

FILGRASTIMBox x 5 pre-

filled syringes

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA ZAGREB D.O.O -

KROACI

REGJ.

118/15.03.2012225

1672

NIVESTIM

Solution for

injection/infusion x

300µg/0.5ml

FILGRASTIMBox x 5 pre-

filled syringes

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA ZAGREB D.O.O -

KROACI

REGJ.

118/15.03.2012425

1673

NIVESTIM

Solution for

injection/infusion x

480µg/0.5ml

FILGRASTIMBox x 5 pre-

filled syringes

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA ZAGREB D.O.O -

KROACI

REGJ.

118/15.03.2012600

Page 223

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224

1674

RETACRIT

Solution for

injection x 1000

IU/0.3ml

EPOETIN ZETA

Box x 6 pre-

filled syringes x

0.3ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

IDT BIOLOGIKA GMBH -

GJERMANI, HOSPIRA

ENTERPRISES BV -

HOLLANDE, STADA

ARZNEIMITTEL AG -

GJERMANI, BRECON

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR, ALLOGA

FRANCE - FRANCE, SVUS

PHARMA AS - REPUBLIKA

CEKE, UPS SCS

(NEDERLAND) BV -

HOLLANDE

REGJ. 433/1 Dt.

28.09.2012

60

1675

RETACRIT

Solution for

injection x 20 000

IU/0.5ml

EPOETIN ZETA

Box x 1 pre-

filled syringe x

0.5ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

IDT BIOLOGIKA GMBH -

GJERMANI, HOSPIRA

ENTERPRISES BV -

HOLLANDE, STADA

ARZNEIMITTEL AG -

GJERMANI, BRECON

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR, ALLOGA

FRANCE - FRANCE, SVUS

PHARMA AS - REPUBLIKA

CEKE, UPS SCS

(NEDERLAND) BV -

HOLLANDE

REGJ. 433/1 Dt.

28.09.2012

150

Page 224

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225

1676

RETACRIT

Solution for

injection x 10 000

IU/1ml

EPOETIN ZETA

Box x 6 pre-

filled syringes x

1ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

IDT BIOLOGIKA GMBH -

GJERMANI, HOSPIRA

ENTERPRISES BV -

HOLLANDE, STADA

ARZNEIMITTEL AG -

GJERMANI, BRECON

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR, ALLOGA

FRANCE - FRANCE, SVUS

PHARMA AS - REPUBLIKA

CEKE, UPS SCS

(NEDERLAND) BV -

HOLLANDE

REGJ. 433/1 Dt.

28.09.2012

500

1677

RETACRIT

Solution for

injection x 30 000

IU/0.75ml

EPOETIN ZETA

Box x 1 pre-

filled syringe x

0.75ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

IDT BIOLOGIKA GMBH -

GJERMANI, HOSPIRA

ENTERPRISES BV -

HOLLANDE, STADA

ARZNEIMITTEL AG -

GJERMANI, BRECON

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR, ALLOGA

FRANCE - FRANCE, SVUS

PHARMA AS - REPUBLIKA

CEKE, UPS SCS

(NEDERLAND) BV -

HOLLANDE

REGJ. 433/1 Dt.

28.09.2012

240

Page 225

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226

1678

RETACRIT

Solution for

injection x 40 000

IU/1ml

EPOETIN ZETA

Box x 1 pre-

filled syringe x

1ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

IDT BIOLOGIKA GMBH -

GJERMANI, HOSPIRA

ENTERPRISES BV -

HOLLANDE, STADA

ARZNEIMITTEL AG -

GJERMANI, BRECON

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR, ALLOGA

FRANCE - FRANCE, SVUS

PHARMA AS - REPUBLIKA

CEKE, UPS SCS

(NEDERLAND) BV -

HOLLANDE

REGJ. 433/1 Dt.

28.09.2012

320

1679

TELMOTENSFilm-coated tablets

x 40mgTELMISARTAN Box x 30

"ALVOGEN IPCo. S.AR.L"

LUXENBURG

"GLENMARK GENERICS

LIMITED" INDI; "GLENMARK

PHARMACEUTICALS SRO";

"TILLOMED LABORATORIES

LTD" UK; "GLENMARK

GENERICS (EUROPE)

LIMITED" UK

Regj.451/13.08.2013

6

1680

TELMOTENSFilm-coated tablets

x 80mgTELMISARTAN Box x 30

"ALVOGEN IPCo. S.AR.L"

LUXENBURG

"GLENMARK GENERICS

LIMITED" INDI; "GLENMARK

PHARMACEUTICALS SRO";

"TILLOMED LABORATORIES

LTD" UK; "GLENMARK

GENERICS (EUROPE)

LIMITED" UK

Regj.451/13.08.2013

8

1681

BLASTOMAT Capsules x 20mg TEMOZOLOMIDEBox x 1 plastic

bottle x 5

"ALVOGEN IPCo. S.AR.L"

LUXENBURG

"GENEPHARM SA" GREQI;

"EIRGEN PHARMA LTD"

IRLANDE; "MILLMOUNT

HEALTHCARE LTD"

IRLANDE

Regj.422/11.07.2013

100

Page 226

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227

1682

BLASTOMAT Capsules x 100mg TEMOZOLOMIDEBox x 1 plastic

bottle x 5

"ALVOGEN IPCo. S.AR.L"

LUXENBURG

"GENEPHARM SA" GREQI;

"EIRGEN PHARMA LTD"

IRLANDE; "MILLMOUNT

HEALTHCARE LTD"

IRLANDE

Regj.422/11.07.2013

250

1683

BLASTOMAT Capsules x 250mg TEMOZOLOMIDEBox x 1 plastic

bottle x 5

"ALVOGEN IPCo. S.AR.L"

LUXENBURG

"GENEPHARM SA" GREQI;

"EIRGEN PHARMA LTD"

IRLANDE; "MILLMOUNT

HEALTHCARE LTD"

IRLANDE

Regj.422/11.07.2013

700

1684

PRIXOTER Film coated tablets

x 500mgLEVOFLOXACINE Box x 7

ALVOGEN IPCo. S.ar.l -

LUKSEMBURG

PHARMATEN SA GREQI

(APLIKANT PER

CERTIFIKATE: ARAMIS

PHARMA KFT - HUNGARI)

REGJ. 61/06.02.2013

13

1685

DESLORATADINE

ALVOGEN

Film - coated

tablets x 5mgDESLORATADINE Box x 10

ALVOGEN IPCo. S.ar.l -

LUKSEMBURGGENEPHARM SA - GREQI

REGJ.

307/07.05.2013 4.2

1686

DESLORATADINE

ALVOGEN

Oral solution x

0.5mg/mlDESLORATADINE

Box x 1 bottle x

120ml

ALVOGEN IPCo. S.ar.l -

LUKSEMBURGGENEPHARM SA - GREQI

REGJ.

307/07.05.20134.2

1687XALVOBIN

Film coated tablets

x 150mgCAPECITABINE Box x 60

ALVOGEN IPCo. S.ar.l -

LUKSEMBURGREMEDICA LTD - QIPRO REGJ. 61/06.02.2013

100

1688XALVOBIN

Film coated tablets

x 500mgCAPECITABINE Box x 120

ALVOGEN IPCo. S.ar.l -

LUKSEMBURGREMEDICA LTD - QIPRO REGJ. 61/06.02.2013

Bleom

ycine

1689

IBANDRONIC

ACID ALVOGEN

Solution for

injection x 3mg/pre-

filled syringe

IBANDRONIC ACIDBox x 1 pre-

filled syringe

ALVOGEN IPCo. S.ar.l -

LUKSEMBURG

SYNTHON BV - HOLLANDE,

SYNTHON HISPANIA SL -

SPANJE

REGJ.

307/07.05.2013

60

1690

MEROPENEM

Pwder for solution

for injection or

infusion x

500mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 570.470mg)

Box x10 glass

vials

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA HEALTHCARE

INDIA PVT LTD - INDI

REGJ.

307/07.05.2013

150

1691

MEROPENEM

Pwder for solution

for injection or

infusion x

1000mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x1140.950mg)

Box x10 glass

vials

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA HEALTHCARE

INDIA PVT LTD - INDI

REGJ.

307/07.05.2013

170

Page 227

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228

1692

IMIPENEM/CILAST

IN 500MG/500MG

Powder for solution

for infusion x

(500mg +

500mg)/vial

IMIPENEM (as IMIPENEM

MONOHYDRATE x 530mg)

+ CILASTATIN (as

CILASTATIN (as

CILASTATIN SODIUM x

530mg)

Box x 5 glass

vials

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR;

HOSPIRA HEALTHCARE

INDIA PRIVATE LTD - INDI

REGJ.

307/07.05.2013

100

1693

ALVODRONIC

Concentrate for

solution for infusion

x 2mg/ml

IBANDRONIC ACID (as

IBANDRONIC SODIUM

MONOHYDRATE)

Box x 1

ampoule x 2ml

PHARMATEN S.A. -

GREQIPHARMATEN S.A. - GREQI REGJ. 70/13.02.2013

120

1694

ALVODRONIC

Concentrate for

solution for infusion

x 6mg/6ml

IBANDRONIC ACID (as

IBANDRONIC SODIUM

MONOHYDRATE)

Box x 1

ampoule x 6ml

PHARMATEN S.A. -

GREQIPHARMATEN S.A. - GREQI REGJ. 70/13.02.2013

240

1695

TOPOTECAN

HOSPIRA

Concentrate for

solution for infusion

x 4mg/4ml

TOPOTECAN (as

HYDROCHLORIDE)Box x 5 vials

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

ZYDUS HOSPIRA

ONCOLOGY PRIVATE

LIMITED - INDI

REGJ. 61/06.02.2013

1250

1696

GEMCITABINE

Concentrate for

solution for infusion

x 1g/vial

GEMCITABINE (x 38mg/ml)Box x 1 glass

vial x 26.3ml

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

HOSPIRA AUSTRALIA PTY

LIMITED - AUSTRALI,

HOSPIRA UK LIMITED -

MBRETERI E BASHKUAR

REGJ.

596/26.11.2012

65

1697

ALVOKASTChewable tablets x

4mg

MONTELUKAST (as

MONTELUKAST SODIUM x

4.15mg)

Box x 28ALVOGEN IPCo. S.ar.l -

LUKSEMBURGPHARMATHEN SA - GREQI

REGJ.

596/26.11.201213

1698

ALVOKASTChewable tablets x

5mg

MONTELUKAST (as

MONTELUKAST SODIUM x

5.188mg)

Box x 28ALVOGEN IPCo. S.ar.l -

LUKSEMBURGPHARMATHEN SA - GREQI

REGJ.

596/26.11.201213

1699

ALVOKASTFilm-coated tablets

x 10mg

MONTELUKAST (as

MONTELUKAST SODIUM x

10.4mg)

Box x 28ALVOGEN IPCo. S.ar.l -

LUKSEMBURGPHARMATHEN SA - GREQI

REGJ.

596/26.11.201213

1700

ZAFITRALOral solution x

1mg/mlRISPERIDONE

Box x 1 glass

bottle x 100ml +

1 dosing device

RAFARM SA - GREQI RAFARM SA - GREQIREGJ.

449/28.10.2011

9.4

Page 228

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229

1701

ACTONORM GEL

Oral suspension x

(220mg + 200mg +

25mg)/5ml

ALUMINIUM HYDROXIDE +

MAGNESIUM HYDROXIDE

+ ACTIVATED

DIMETHICONE

Box x 1 glass

bottle x 200ml

WALLACE

MANUFACTURING

CHEMISTS LIMITED -

MBRETERI E BASHKUAR

THORPE LABORATORIES

LIMITED - MBRETERI E

BASHKUAR

RIREGJ.

429/04.08.2009

8.94

1702

NERITA

Powder for oral

solution x

1500mg/sachet

GLUCOSAMINE SULPHATE

(as GLUCOSAMINE

SULPHATE SODIUM SALT x

1884mg/sachet)

Box x 30

sachets

DELEGANT HOLDINGS

LTD - QIPRO

RAFARM SA - GREQI (APL:

LIBYTEC PHARMACEUTICAL

SA - GREQI)

REGJ.

526/23.12.2011

7.7

1703

YARDEL

Solution for

injection x

20mg/2ml

HYALURONATE SODIUMBox x 1 pre-

filled syringe

DELEGANT HOLDINGS

LTD - QIPRO

IBSA FARMACEUTICI ITALIA

SRL - ITALI,

IMPFSTOFFWERK DESSAU-

TORNAU GMBH - GJERMANI

(APL: LIBYTEC

PHARMACEUTICAL SA -

GREQI)

REGJ.

526/23.12.2011

19.2

1704

GENOTROPIN

GoQuick

Powder and

solvent for solution

for injection x

5.3mg/1ml

SOMATROPIN Box x 1pre-filled

pen (1ml)"PFIZER SA" BELGJIKE

"VETTER PHARMA-

FERTIGUNG GMBH & CO.KG

(LANGENARGEN SITE)"

GJERMANI; "VETTER

PHARMA-FERTIGUNG GMBH

& CO.KG (RAVENSBURG

SITE)" GJERMANI; "PFIZER

MANUFACTURING BELGIUM

NV" BELGJIKE dhe me

aplikant per çertifikate

"PFIZER MANUFACTURING

BELGIUM NV" BELGJIKE

Regj.422/11.07.2013

98

Page 229

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230

1705

GENOTROPIN

GoQuick

Powder and

solvent for solution

for injection x

12mg/1ml

SOMATROPIN Box x 1pre-filled

pen (1ml)"PFIZER SA" BELGJIKE

"VETTER PHARMA-

FERTIGUNG GMBH & CO.KG

(LANGENARGEN SITE)"

GJERMANI; "VETTER

PHARMA-FERTIGUNG GMBH

& CO.KG (RAVENSBURG

SITE)" GJERMANI; "PFIZER

MANUFACTURING BELGIUM

NV" BELGJIKE dhe me

aplikant per çertifikate

"PFIZER MANUFACTURING

BELGIUM NV" BELGJIKE

Regj.422/11.07.2013

225.33

1706

VANCOMICINA

HIKMA

Powder for solution

for infusion and for

oral solution x

500mg/flacon

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE x

512.57mg)

Box x 1 flacon HIKMA ITALIA SPA - ITALI HIKMA ITALIA SPA - ITALIREGJ.

173/30.03.2010

3

1707

VANCOMICINA

HIKMA

Powder for solution

for infusion and for

oral solution x

1g/flacon

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE x

1025.14mg)

Box x 1 flacon HIKMA ITALIA SPA - ITALI HIKMA ITALIA SPA - ITALIREGJ.

173/30.03.2010

5

1708

DIPHERELINE

0.1MG

Powder and

solvent for solution

for injection x

0.1mg

TRIPTORELIN

Box x 7 vials

with powder + 7

ampoules with

solvent

BEAUFOUR IPSEN

PHARMA - FRANCE

IPSEN PHARMA BIOTECH -

FRANCE

RIREGJ.

578/02.11.2009

27.6

1709

DIPHERELINE

S.R. 3.75MG

Powder and

solvent for

suspension for

injection (I.M), 28-

day prolonged

release form x

3.75mg

TRIPTORELIN

Box x 1 vial with

powder + 1

ampoule with

solvent + 1

syringe

BEAUFOUR IPSEN

PHARMA - FRANCE

IPSEN PHARMA BIOTECH -

FRANCE

RIREGJ.

578/02.11.2009

110

Page 230

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231

1710

DIPHERELINE

S.R. 11.25MG

Powder and

solvent for

suspension for

injection (I.M), 3-

month prolonged

release form x

11.25mg

TRIPTORELIN

Box x 1 vial with

powder + 1

ampoule with

solvent + 1

syringe

BEAUFOUR IPSEN

PHARMA - FRANCE

IPSEN PHARMA BIOTECH -

FRANCE

RIREGJ.

578/02.11.2009

323

1711FENOSUP LIDOSE Capsules x 160mg FENOFIBRATE Box x 30

LABORATOIRES SMB SA -

BELGJIKE

SMB TECHNOLOGY SA -

BELGIUM

REGJ.

264/12.06.2012 6

1712

CARDIOPIRIN

FORTE

Film-coated tablets

x 300mgACETYLSALICYLIC ACID Box x 30

LANNACHER

HEILMITTEL GMBH -

AUSTRI

G.L. PHARMA GMBH -

AUSTRI

REGJ.

188/12.05.20111.2

1713

DICLORAPID

Gastro-resistant

hard capsules x

75mg

DICLOFENAC SODIUM Box x 20PHARMASWISS D.O.O -

SERBI

PHARMASWISS D.O.O -

SERBI; TEMMLER WERKE

GMBH - GJERMANI

RIREGJ.

471/11.11.2011

2.12

1714

DICLOFENAC

DUO 75MG

Prolonged-release

hard capsules x

75mg

DICLOFENAC SODIUM Box x 30

PHARMASWISS CESKA

REPUBLIKA SRO -

REPUBLIKA CEKE

TEMMLER WERKE GMBH -

GJERMANI (APL:

PHARMASWISS LTD -

BULLGARI)

REGJ.

433/29.07.2010

4

1715

PACLITAXEL

PHARMASWISS

Concentrate for

solution for infusion

x 30mg/5ml

PACLITAXELBox x 1 vial x

5ml

PHARMASWISS D.O.O -

SERBI

HAUPT PHARMA

WOLFRATSHAUSEN GMBH -

GJERMANI; PHARMASWISS

D.O.O - SERBI

REGJ.

188/12.05.2011

20

1716

BICADEXFilm-coated tablets

x 50mgBICALUTAMIDE Box x 28

PHARMASWISS D.O.O -

SERBI

KOCAK FARMA ILAC VE

KIMYA SANAYI AS - TURQI;

PHARMASWISS D.O.O -

SERBI

REGJ.

212/25.05.2011

50

1717CARDIOPIRIN

Gastro-resistant

tablets x 100mgACETYLSALICYLIC ACID Box x 30

PHARMASWISS D.O.O -

SLLOVENI

G.L. PHARMA GMBH -

AUSTRI

RIREGJ.

297/18.07.2011 1.1

1718

MEROCID

Powder for solution

for

injection/infusion x

500mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 570mg/vial)

Box x 10 vials

(for hospital

use)

PHARMASWISS D.O.O -

SERBI

PHARMASWISS D.O.O -

SERBI ; ANFARM HELLAS SA

- GREQI; FACTA

FARMACEUTICI SPA - ITALI

REGJ.

118/15.03.2012

100

Page 231

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232

1719

MEROCID

Powder for solution

for

injection/infusion x

1000mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x

1140mg/vial)

Box x 10 vials

(for hospital

use)

PHARMASWISS D.O.O -

SERBI

PHARMASWISS D.O.O -

SERBI ; ANFARM HELLAS SA

- GREQI; FACTA

FARMACEUTICI SPA - ITALI

REGJ.

118/15.03.2012

150

1720

MIPECID

Powder for solution

for infusion x

(500mg +

500mg)/vial

IMIPENEM (as IMIPENEM

MONOHYDRATE x

530mg/vial) + CILASTATIN

(as SODIUM CILASTATIN x

530mg/vial)

Box x 10 vials

(for hospital

use)

PHARMASWISS D.O.O -

SERBI

PHARMASWISS D.O.O -

SERBI ; ANFARM HELLAS SA

- GREQI; FACTA

FARMACEUTICI SPA - ITALI

REGJ.

118/15.03.2012

95

1721

RAPIDOLSoft gelatin

capsules x 200mgIBUPROFEN Box x 20

PHARMASWISS D.O.O -

SERBI

PHARMASWISS D.O.O -

SERBI; BANNER

PHARMACAPS EUROPE BV -

HOLLANDE; GELTEC

PRIVATE LTD - INDI

REGJ.

213/09.05.2012

2

1722

PIPERACILLIN/TA

ZOBACTAM

STRAGEN

Powder for solution

for injection or

infusion x (4g +

0.5g)/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM) +

TAZOBACTAM (as

TAZOBACTAM SODIUM)

Box x 10 vials (

for hospital use

only)

STRAGEN NORDIC A/S -

DANIMARKEMITIM SRL - ITALI

REGJ.

310/17.05.2010

100

1723

FEXOFENADIN EFilm - coated

tablets x 120mg

FEXOFENADIN

HYDROCHLORIDE (eq. Box x 30

"CHANELLE MEDICAL"

IRLANDE

"CHANELLE MEDICAL"

IRLANDE; "CIPLA LTD" INDIRegj.422/11.07.2013

7.5

1724

AULIN 100 Granules x 100 mg NIMESULIDEBox x 30

Sachets

HELSINN BIREX

PHARMACEUTICALS

LIMITED - IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE

REGJ. 42/28.01.2009

6

1725

AULIN 100 Tablets x 100 mg NIMESULIDE Box x 30

HELSINN BIREX

PHARMACEUTICALS

LIMITED - IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE

REGJ. 42/28.01.2009

5.5

1726

AULIN 3% Gel x 3g/100g NIMESULIDE Box x 1 tube x

50g

HELSINN BIREX

PHARMACEUTICALS LTD

- IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE

RIREGJ.

109/01.03.20136

1727

ALOXI

Solution for

injection x

250mcg/5ml

PALONOSETRON (as

HYDROCHLORIDE)

Box x 1 vial x

5ml

HELSINN BIREX

PHARMACEUTICALS LTD

- IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE; CATALENT

PHARMA SOLUTIONS -

SHBA

REGJ. 49/

04.02.2013

70

Page 232

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233

1728

ALOXISoft capsules x

500mcg

PALONOSETRON

HYDROCHLORIDEBox x 1

HELSINN BIREX

PHARMACEUTICALS LTD

- IRLANDE

HELSINN BIREX

PHARMACEUTICALS LTD -

IRLANDE; CATALENT

PHARMA SOLUTIONS -

SHBA

REGJ. 49/

04.02.2013

70

1729

PARASIDOSEShampo x

0.2g/100mlPHENOTHRINE

Box x 1 bottle x

100ml

LABORATOIRES

GILBERT - FRANCE

LABORATOIRES GILBERT -

FRANCE

REGJ.

307/07.05.20132.42

1730

NIBERAN Tablets x 100mg NIMESULIDE Box x 30 BALU LTD - GREQI

PHARMACEUTICAL

INDUSTRY PROEL S.A. -

GREQI, RAFARM SA - GREQI

REGJ.

565/27.10.2009

2.6

1731

ZITHROPLUSFilm-coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524mg)

Box x 3 BALU SA - GREQI RAFARM SA - GREQIREGJ.

526/23.12.20112.8

1732

ZITHROPLUSFilm-coated tablets

x 600mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 628.8mg)

Box x 8 BALU SA - GREQI RAFARM SA - GREQIREGJ.

526/23.12.201110

1733

ARTHROLOC

Powder for oral

solution x

1500mg/sachet

GLUCOSAMINE SULPHATE

(as GLUCOSAMINE

SULPHATE SODIUM SALT x

1884mg/sachet)

Box x 30

sachetsBALU SA - GREQI RAFARM SA - GREQI

REGJ.

526/23.12.2011

7.74

1734

ACTIFED Syrup x 30 mg/5ml

+ 1.25mg/5ml

PSEUDOEPHEDRINE

HYDROCHLORIDE +

TRIPROLIDINE

HYDROCHLORIDE

Box x bottle x

100ml

GLAXO GROUP LTD -

MBRETERI E BASHKUAR

ASPEN BAD OLDESLOE

GMBH - GJERMANI (APL:

GLAXOSMITHKLINE

(CYPRUS) LTD - QIPRO)

REGJ.

197/25.03.2009

2.48

Page 233

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234

1735

INFANRIX HEXA

Powder &

suspension for

suspension for

injection x (25μg +

25μg + 8μg + not

less than 30 IU +

not less than 40IU

+ 10μg + 40 D-

antigen unit + 8 D-

antigen unit + 32 D-

antigen unit + 10μg

PRP and 20-40μg

of TT) / 0.5ml

PERTUSSIS TOXOID

ADSORBED (PT) +

FILAMENTOUS

HAEMAGGLUTININ

ADSORBED (FHA) +

PERTACTIN ADSORBED

(69 kDa OUTER

MEMBRANE PROTEIN-

PRN) + DIPHTERIA TOXOID

ADSORBED (D) + TETANUS

TOXOID ADSORBED (T) + r-

DNA HEPATITIS B

SURFACE ANTIGEN

ADSORBED (HBsAg) +

INACTIVATED POLIO

VIRUS (IPV) TYPE 1 +

INACTIVATED POLIO

VIRUS (IPV) TYPE 2 +

INACTIVATED POLIO

VIRUS (IPV) TYPE 3 +

CONJUGATE OF

HAEMOPHILUS

INFLUENZAE TYPE B

CAPSULAR

POLYSACCHARIDE (PRP)

AND TETANUS TOXOID (T)

ADSORBED (PRP-T)

Box x (1 vial +

1 pre-filled

syringe)

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE;

GLAXOSMITHKLINE

BIOLOGICALS - SAINT-

AMAND-LES-EAUX,

FRANCE;

GLAXOSMITHKLINE

BIOLOGICALS (BRANCH OF

SMITHKLINE BEECHAM

PHARMA GMBH & CO.KG -

GJERMANI

REGJ.

197/25.03.2009

33.37

Page 234

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235

1736

EPIVIRFilm coated tablets

x 150mgLAMIVUDINE Box x 60

ViiV HEALTHCARE UK

LIMITED - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LIMITED - MBRETERIA E

BASHKUAR (trading as

GLAXO WELLCOME

OPERATIONS) - MBRETERIA

E BASHKUAR,

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI

RIREGJ.

685/15.12.2008

154.35

1737

TYVERBFilm coated tablets

x 250 mg

LAPATINIB ( as LAPATINIB

DITOSYLATE

MONOHYDRATE)

Box x 70GLAXO GROUP LIMITED -

MBRETERI E BASHKUAR

GLAXO OPERATIONS UK

LTD trading as GLAXO

WELCOME OPERATIONS -

MBRETERIA E BASHKUAR;

GLAXO WELLCOME SA -

SPANJE

REGJ.

180/18.03.2009

1093.4

1738

PRIORIX

Powder/lyophilisate

+ solvent

(injectable vaccine)

x Not less than

(103.0 CCID50 +

103.7 CCID50 +

103.0 CCID50) / 1

dose (0.5ml)

LIVE ATTENUATED

MEASLES VIRUS

(SCHWARZ STRAIN) + LIVE

ATTENUATED MUMPS

VIRUS (RIT 4385 STRAIN) +

LIVE ATTENUATED

RUBELLA VIRUS (RA 27/3

STRAIN)

Box x (1 vial

with lyophilised

vaccine + 1 pre-

filled syringe

with diluent + 2

needles)

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE,

GLAXOSMITHKLINE

BIOLOGICALS - FRANCE,

[DELPHARM TOURS -

FRANCE (for the Sterile Water

for Injection diluent)]; CRNA -

BELGJIKE

REGJ.

197/25.03.2009

9.77

1739

AVAMYS

Nasal spray

suspension x

27.5µg/spray

FLUTICASONE FUROATEBox x 1 device x

120 sprays

GLAXO GROUP LTD -

MBRETERI E BASHKUAR

GLAXO OPERATIONS UK

LTD trading as GLAXO

WELCOME OPERATIONS -

MBRETERIA E BASHKUAR

REGJ.

324/22.05.2009

6.34

Page 235

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236

1740

SEROXAT

Divisible Film

Coated Tablets x

20 mg

PAROXETINE (as

PAROXETINE

HYDROCHLORIDE

HEMIHYDRATE)

Box x 30

SMITHKLINE BEECHAM

PLC - MBRETERI E

BASHKUAR

GLAXO WELLCOME

PRODUCTION - FRANCE,

SMITHKLINE BEECHAM PLC -

MBRETERI E BASHKUAR;

EUROPHARM SA - RUMANI

RIREGJ.

339/03.06.2009

12.19

1741

AUGMENTIN

Powder for

injection x (1g +

200mg)

AMOXYCILLIN +

CLAVULANATE

POTASSIUM

Box x 10 vials

BEECHAM GROUP PLC -

MBRETERIA E

BASHKUAR

BEECHAM GROUP PLC -

MBRETERIA E BASHKUAR;

SMITHKLINE BEECHAM PLC -

MBRETERI E BASHKUAR

(APLIKANT: SMITHKLINE

BEECHAM

PHARMACEUTICALS -

MBRETERI E BASHKUAR)

RIREGJ.

446/26.08.2009

23

1742

ARIXTRA

Solution for

injection x

2.5mg/0.5ml

FONDAPARINUX SODIUMBox x 10 pre-

filled syringes

GLAXO GROUP LTD -

MBRETERI E BASHKUAR

GLAXO WELLCOME

PRODUCTION - FRANCE

REGJ.

573/27.10.200939.06

1743

ALTARGOOintment x 1%

(w/w)RETAPAMULIN

Box x 1 tube x

5g

GLAXO GROUP LTD -

MBRETERI E BASHKUAR

GLAXO OPERATIONS UK

LTD (trading as GLAXO

WELLCOME OPERATIONS) -

MBRETERI E BASHKUAR

REGJ. 58/02.02.2010

7.05

Page 236

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237

1744

SYNFLORIX

Suspension for

injection x (1µg +

3µg + 1µg + 1µg +

1µg + 1µg + 1µg +

3µg + 3µg + 1µg) /

1 dose (0.5ml)

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 11,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 41,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 51,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 6B1,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 7F1,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 9V1,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 141,2

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 18C1,3

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 19F1,4

+

PNEUMOCOCCAL

POLYSACCHARIDE

SEROTYPE 23F1,2

[1

adsorbed on aluminium

phosphate 0.5mg Al3+

, 2

conjugated to protein D

(derived from non-typeable

Haemophilus influenzae)

carrier protein 9-16µg, 3

conjugated to tetanus toxoid

Box x [1 pre-

filled syringe x

0.5ml (1 dose) +

1 needle]

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE;

GLAXOSMITHKLINE

BIOLOGICALS - FRANCE

REGJ.

445/03.08.2010

30

Page 237

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238

1745

FLUARIX

Suspension for

i.m./s.c. injection x

(15µg + 15µg +

15µg)/0.5ml

A/CALIFORNIA/7/2009

(H1N1) PDM09-LIKE

STRAIN [VARIANT

A/CHRISTCHURCH/16/2010

(NIB-74XPL)]

A/VICTORIA/361/2011

(H3N2)-LIKE STRAIN

[VARIANT

A/VICTORIA/361/2011 (IVR-

165)]

A/WISCONSIN/1/2010-LIKE

STRAIN [VARIANT B/HUBEI-

WUJIANGANG/158/2009

(NYMC BX-39)]

Box x 1 prefilled

syringe with

fixed needle

GLAXOSMITHKLINE

BIOLOGICALS BRANCH

OF SMITHKLINE

BEECHAM PHARMA

GMBH & CO. KG -

GJERMANI

GLAXOSMITHKLINE

BIOLOGICALS BRANCH OF

SMITHKLINE BEECHAM

PHARMA GMBH & CO. KG -

GJERMANI

RIREGJ.

489/10.09.2010

6.19

1746

ROTARIX

Oral suspension x

not less than 106.0

CCID50 / 1 dose

(1.5ml)

HUMAN ROTAVIRUS

RIX4414 STRAIN (LIVE,

ATTENUATED)

Box x Oral

Applicator x

1.5ml (1 dose),

Box x

Squeezable

Tube x 1.5ml (1

dose)

GLAXOSMITHKLINE

BIOLOGICALS SA -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS SA -

BELGJIKE,

GLAXOSMITHKLINE

BIOLOGICALS - FRANCE

REGJ.

526/01.10.2010

17

1747

VOTRIENTFilm-coated tablets

x 200mg

PAZOPANIB (as

PAZOPANIB

HYDROCHLORIDE)

Box x plastic

bottle x 30

GLAXO GROUP LIMITED,

GLAXO WELLCOME

HOUSE - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LIMITED, (TRADING AS

GLAXO WELLCOME

OPERATIONS) - MBRETERI

E BASHKUAR; GLAXO

WELLCOME SA - SPANJE

REGJ. 23/13.01.2011

696.3

1748

VOTRIENTFilm-coated tablets

x 400mg

PAZOPANIB (as

PAZOPANIB

HYDROCHLORIDE)

Box x plastic

bottle x 30

GLAXO GROUP LIMITED,

GLAXO WELLCOME

HOUSE - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LIMITED, (TRADING AS

GLAXO WELLCOME

OPERATIONS) - MBRETERI

E BASHKUAR; GLAXO

WELLCOME SA - SPANJE

REGJ. 23/13.01.2011

1392.6

Page 238

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239

1749

AVODARTSoft capsules x

0.5mgDUTASTERIDE Box x 30

LABORATOIRE

GLAXOSMITHKLINE -

FRANCE

CATALENT FRANCE

BEINHEIM SA - FRANCE

RIREGJ.

450/31.10.201120.77

1750

PROLIASolution for

injection x 60mg/mlDENOSUMAB

Box x 1

blistered pre-

filled syringe

AMGEN EUROPE BV -

HOLLANDE

AMGEN MANUFACTURING

LIMITED - PORTO RIKO,

AMGEN EUROPE BV -

HOLLANDE

REGJ.

528/23.12.2011

192.23

1751

ZANTAC

Solution for

injection x

50mg/2ml

RANITIDINE (as

RANITIDINE

HYDROCHLORIDE x

56mg/2ml)

Box x 5

ampoules x 2ml

GLAXO WELLCOME UK

LIMITED - MBRETERI E

BASHKUAR

GLAXOSMITHKLINE

MANUFACTURING SPA -

ITALI

RIREGJ.

105/06.03.2012

3.65

1752

FORTUM

Powder for solution

for injection x

1g/vial

CEFTAZIDIME (as

CEFTAZIDIME

PENTAHYDRATE)

Box x 1 vial

GLAXO OPERATIONS UK

LIMITED - MBRETERI E

BASHKUAR

GLAXOSMITHKLINE

MANUFACTURING SPA -

ITALI

RIREGJ.

105/06.03.2012

4.98

Page 239

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240

1753

INFANRIX-IPV +

HIB

Powder (Hib) and

suspension for

injection (Infanrix-

IPV) for

suspension for

injection x 30 to

50µg/vial (Hib) and

(min. 30 UI + min.

40 UI + 25µg +

25µg + 8µg +

0.5mg* + 40 DU +

8 DU + 32 DU) /

0.5ml

Powder in vial (HIB):

CONJUGATE OF PURIFIED

CAPSULAR

POLYSACCHARIDE OF HIB

(HAEMOPHILUS

INFLUENZAE TYPE B) AND

TETANUS TOXOID (corresp.

to 10µg of HIB PURIFIED

POLYSACCHARIDE);

Suspension in prefilled

syringe (Infanrix-IPV):

DIPHTHERIA TOXOID-(DT)

+ TETANUS TOXOID (TT) +

PERTUSSIS TOXOID (PT) +

FILAMENTOUS

HAEMAGGLUTININ-(FHA) +

PERTACTIN (69kDA OUTER

MEMBRANE PROTEIN) +

ADSORBED ON

ALUMINIUM SALTS (as

ALUMINIUM HYDROXIDE

SUSPENSION) *expressed

in ALUMINIUM +

INACTIVATED POLIO

VIRUS TYPE 1 (MAHONEY

STRAIN) + INACTIVATED

POLIO VIRUS TYPE 2 (MEF-

1 STRAIN) + INACTIVATED

POLIO VIRUS TYPE 3

(SAUKETT STRAIN)

Box x 1 vial + 1

prefilled syringe

+ 2 needles

GLAXOSMITHKLINE

BIOLOGICALS SA -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS SA -

BELGJIKE

REGJ.

132/26.03.2012

25

1754

ZINNATFilm-coated tablets

x 250mg

CEFUROXIME (as

CEFUROXIME AXETIL x

300.72mg)

Box x 10

GLAXO WELLCOME UK

LIMITED - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LIMITED - MBRETERI E

BASHKUAR (APL: GLAXO

WELLCOME OPERATIONS -

MBRETERI E BASHKUAR)

RIREGJ.

166/19.04.2012

6.39

Page 240

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241

1755

ZINNATFilm-coated tablets

x 500mg

CEFUROXIME (as

CEFUROXIME AXETIL x

601.44mg)

Box x 10

GLAXO WELLCOME UK

LIMITED - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LIMITED - MBRETERI E

BASHKUAR (APL: GLAXO

WELLCOME OPERATIONS -

MBRETERI E BASHKUAR)

RIREGJ.

166/19.04.2012

10.19

1756

VENTOLIN

Solution for

nebulisation x

5mg/ml

SALBUTAMOL [as

SALBUTAMOL SULPHATE x

0.6% (w/v)]

Box x 1 glass

bottle x 20ml

GLAXO WELLCOME UK

LIMITED - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LIMITED - MBRETERI E

BASHKUAR (APL: GLAXO

WELLCOME OPERATIONS -

MBRETERI E BASHKUAR)

RIREGJ.

190/27.04.2012

2.89

1757

DERMOVATEOintment x

0.5mg/g

CLOBETASOL

PROPIONATE

Box x 1 tube x

25g

GLAXOSMITHKLINE

EXPORT LTD -

MBRETERI E BASHKUAR

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI (APL:

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI)

RIREGJ.

260/12.06.2012

3.1

1758

DERMOVATE Cream x 0.5mg/gCLOBETASOL

PROPIONATE

Box x 1 tube x

25g

GLAXOSMITHKLINE

EXPORT LTD -

MBRETERI E BASHKUAR

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI (APL:

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI)

RIREGJ.

260/12.06.2012

3.28

1759

RELENZA

Inhalation powder,

pre-dispensed x

5mg/dose

ZANAMIVIR

Box x [(1 plastic

bottle x 5

Rotadisk) + 1

Diskhaler]

GLAXO WELLCOME UK

LIMITED - MBRETERI E

BASHKUAR

GLAXOSMITHKLINE

PRODUCTION - FRANCE,

GLAXOSMITHKLINE

AUSTRALIA PTY LIMITED -

AUSTRALI (APL: GLAXO

WELLCOME OPERATIONS -

MBRETERI E BASHKUAR)

RIREGJ.

336/20.07.2012

7.8

Page 241

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242

1760

IMIGRANFilm coated tablets

x 100mg

SUMATRIPTAN (AS

SUMATRIPTAN

SUCCINATE x 140MG)

Box x 2 tabs

GLAXO WELLCOME UK

LTD - MBRETERI E

BASHKUAR

GLAXO OPERATIONS UK

LTD - MBRETERI E

BASHKUAR,

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI

RIREGJ.

351/31.07.2012

10.58

1761

ZINACEF

Powder for solution

for injection x

750mg/vial

CEFUROXIME (AS

CEFUROXIME SODIUM x

829.980MG/VIAL)

Box x 1 glass

vial

GLAXO OPERATIONS UK

LIMITED - MBRETERI E

BASHKUAR

GLAXOSMITHKLINE

MANUFACTURING SPA -

ITALI (APL: GLAXO

WELLCOME OPERATIONS -

MBRETERI E BASHKUAR)

RIREGJ.

351/31.07.2012

2.99

1762

FLIXONASE

Nasal spray

suspension x

50µg/actuation

FLUTICASONE

PROPIONATE

(MICRONISED)

Box x 1 flacon x

120 doses

GLAXOSMITHKLINE

EXPORT LTD -

MBRETERI E BASHKUAR

GLAXO WELLCOME SA -

SPANJE,

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI (APL:

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI)

RIREGJ.

417/10.09.2012

6.04

1763

AUGMENTIN SR

1000/62.5mg

Sustained release

film-coated tablets

x (562.5mg +

437.5mg +

62.5mg)

AMOXICILLIN (as

TRIHYDRATE x 654.1MG) +

AMOXICILLIN (as SODIUM

SALT x 480.8MG) +

CLAVULANIC ACID (as

POTASSIUM SALT x

76.2mg)

Box x 28GLAXOSMITHKLINE SA -

MBRETERI E BASHKUAR

GLAXO WELLCOME

PRODUCTION - FRANCEREGJ. 61/06.02.2013

9.2

1764 DUODART

Hard capsules x

(0.5 mg + 0.4mg)

DUTASTERIDE +

TAMSULOSIN

HYCHLORIDE Bottle x 30

"GLAXOSMITHKLINE UK

LIMITED" MBRETERI E

BASHKUAR

"CATALENT GERMANY

SCHORNDORF GMBH"

GJERMANI

Regj.

384/ 17.06.2013

22.5

1765SURFONT Tablets x 100mg MEBENDAZOLE Box x 6

"ARDEYPHARM GMBH"

GJERMANI

"ARDEYPHARM GMBH"

GJERMANI

Regj.

359/28.05.2013 2.3

1766

MYKOTIN

MUNDGEL

Oromucosal gel x

20mg/gMICONAZOLE

Box x Tube x

40g

"ARDEYPHARM GMBH"

GJERMANI

"ARDEYPHARM GMBH"

GJERMANI

Regj.

359/28.05.2013 4

1767ADICLAIR

Vaginal tablets x

100.000 I.U.NYSTATIN Box x 12

"ARDEYPHARM GMBH"

GJERMANI

"ARDEYPHARM GMBH"

GJERMANI

Regj.

359/28.05.2013 3.5

Page 242

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243

1768ADICLAIR

Suspension x

100.000 I.U./mlNYSTATIN

Box x flacon x

48ml

"ARDEYPHARM GMBH"

GJERMANI

"ARDEYPHARM GMBH"

GJERMANI

Regj.

359/28.05.2013 4.5

1769ADICLAIR

Ointment x

100.000 I.U./gNYSTATIN

Box x tube x

20g

"ARDEYPHARM GMBH"

GJERMANI

"ARDEYPHARM GMBH"

GJERMANI

Regj.

359/28.05.2013 3.5

1770ADICLAIR

Cream x 100.000

I.U./gNYSTATIN

Box x tube x

20g

"ARDEYPHARM GMBH"

GJERMANI

"ARDEYPHARM GMBH"

GJERMANI

Regj.

359/28.05.2013 3.5

1771

HERPLEX Cream x 50mg/g ACICLOVIR Box x tube x 5g

BELUPO,

PHARMACEUTICALS &

COSMETICS - KROACI

BELUPO,

PHARMACEUTICALS &

COSMETICS - KROACI

REGJ.

565/27.10.2009

2

1772

HERPLEX Cream x 50mg/g ACICLOVIRBox x tube x

10g

BELUPO,

PHARMACEUTICALS &

COSMETICS - KROACI

BELUPO,

PHARMACEUTICALS &

COSMETICS - KROACI

REGJ.

565/27.10.2009

3

1773 AFLODERM

Ointment x

0.5mg/g

ALCLOMETHASONE

DIPROPIONATE

Box x 1 tube x

20g

"BELUPO , LIJEKOVI I

KOZMETIKA D.D"

KROACI

"BELUPO , LIJEKOVI I

KOZMETIKA D.D" KROACI

Riregj.

385/ 17.06.20132.37

1774 AFLODERM Cream x 0.5mg/1g

ALCLOMETHASONE

DIPROPIONATE

Box x 1 tube x

20g

"BELUPO , LIJEKOVI I

KOZMETIKA D.D"

KROACI

"BELUPO , LIJEKOVI I

KOZMETIKA D.D" KROACI

Riregj.

385/ 17.06.20132.37

1775 CALIXTA Tablets x 30 mg MIRTAZAPINE Box x 30

"BELUPO , LIJEKOVI I

KOZMETIKA D.D"

KROACI

"BELUPO , LIJEKOVI I

KOZMETIKA D.D" KROACI

Riregj.

385/ 17.06.201310

1776

BELODERM Cream x 0.5 mg/g

BETAMETHASONE (as

BETAMETHASONE

DIPROPIONATE x 0.64

mg/g)

Box x 1 Tube x

30 g

BELUPO, LIJEKOVI I

KOZMENTIKA D.D. -

KROACI

BELUPO, LIJEKOVI I

KOZMENTIKA D.D. - KROACI

REGJ.

656/20.11.2008

2.83

1777

BELODERMOintment x

0.5mg/g

BETAMETHASONE (as

BETAMETHASONE

DIPROPIONATE)

Box x 1 tube x

30g

BELUPO, LIJEKOVI I

KOZMETIKA D.D -

KROACI

BELUPO, LIJEKOVI I

KOZMETIKA D.D - KROACI

RIREGJ.

597/26.11.20122.95

1778 BELOGENT

Cream x (0.5mg +

1mg)/1g

BETAMETHASONE

DIPROPIONATE +

GENTAMICIN SULPHATE

Box x 1 tube x

15g

"BELUPO , LIJEKOVI I

KOZMETIKA D.D"

KROACI

"BELUPO , LIJEKOVI I

KOZMETIKA D.D" KROACI

Riregj.

385/ 17.06.2013

1.9

1779 BELOGENT

Oint. X (0.5mg +

1mg)/1g

BETAMETHASONE

DIPROPIONATE +

GENTAMICIN SULPHATE

Box x 1 tube x

15g

"BELUPO , LIJEKOVI I

KOZMETIKA D.D"

KROACI

"BELUPO , LIJEKOVI I

KOZMETIKA D.D" KROACI

Riregj.

385/ 17.06.2013

1.9

Page 243

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244

1780

BELOSALICLotion x (0.5mg +

20mg)/g

BETAMETHASONE (as

BETAMETHASONE

DIPROPIONATE) +

SALICYLIC ACID

Box x 1 flacon x

50ml

BELUPO, LIJEKOVI I

KOZMETIKA D.D -

KROACI

BELUPO, LIJEKOVI I

KOZMETIKA D.D - KROACI

RIREGJ.

597/26.11.2012

3.5

1781

BELOSALICOintment x (0.5mg

+ 30mg)/g

BETAMETHASONE (as

BETAMETHASONE

DIPROPIONATE) +

SALICYLIC ACID

Box x 1 tube x

30g

BELUPO, LIJEKOVI I

KOZMETIKA D.D -

KROACI

BELUPO, LIJEKOVI I

KOZMETIKA D.D - KROACI

RIREGJ.

597/26.11.2012

3.2

1782

URUTAL Tablets x 24mgBETAHISTINE

DIHYDROCHLORIDEBox x 20;

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

Regj. 390/

17.06.2013

6

1783

URUTAL Tablets x 24mgBETAHISTINE

DIHYDROCHLORIDE Box x 50

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

Regj. 390/

17.06.2013

16

1784

SONA Gel x 1mg/g ADAPALENEBox x 1 plastic

tube x 30g

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

Regj. 390/

17.06.2013

4.44

1785

SONA Cream x 1mg/g ADAPALENE

Box x 1

aluminium tube

x 30g

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

"BELUPO

PHARMACEUTICALS &

COSMETICK INC."

REPUBLIKA E KROACISE

Regj. 390/

17.06.2013

5

1786

ABUFENE Tablets x 400mg BETA-ALANINE Box x 30

LABORATOIRES

BOUCHARA-RECORDATI -

FRANCË

LABORATOIRES BOUCHARA-

RECORDATI - FRANCË

RIREGJ.

446/03.08.2010

3.56

1787

HEXAPNEUMINE

ADULTS

Syrup x (0.12g +

0.012g + 0.2g) /

100ml

PHOLCODINE +

CHLORPHENIRAMINE

MALEATE + BICLOTYMOL

Box x 1 fl x

200ml

BOUCHARA-RECORDATI -

FRANCE

BOUCHARA-RECORDATI -

FRANCE

RIREGJ.

531/14.10.2009

2.1

1788

HEXAPNEUMINE

CHILDREN

Syrup x (0.1g +

0.01g + 0.15g) /

100ml

PHOLCODINE +

CHLORPHENIRAMINE

MALEATE + BICLOTYMOL

Box x 1 fl x

200ml, Box x 1 fl

x 100ml

BOUCHARA-RECORDATI -

FRANCE

BOUCHARA-RECORDATI -

FRANCE

RIREGJ.

531/14.10.2009

1.31

Page 244

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245

1789

OTOFAEar drops solution

x 2.6g/100ml

RIFAMYCIN SODIUM (eq. to

RIFAMYCIN x 2 000 000 IU /

100ml)

Box x 1 flacon x

10ml

BOUCHARA-RECORDATI -

FRANCE

BOUCHARA-RECORDATI -

FRANCE

RIREGJ.

339/03.06.20092.74

1790

PANFUREX Oral suspension x

4% (w/w)NIFUROXAZIDE

Box x 1 bottle x

90ml

LABORATOIRES

BOUCHARA-RECORDATI -

FRANCË

LABORATOIRES BOUCHARA-

RECORDATI - FRANCË

RIREGJ.

48/30.01.2012

2.69

1791

POLYDEXA

Ear solution drops

x [(1g = 650 000

IU) + 1 000 000 IU

+ 0.1g]

NEOMYCIN SULPHATE +

POLYMYXIN B SULPHATE +

DEXAMETHASONE

SODIUM

METASULPHOBENZOATE

Box x 1 flacon x

10.5ml with

dropper

BOUCHARA-RECORDATI -

FRANCE

BOUCHARA-RECORDATI -

FRANCE

RIREGJ.

251/23.04.2009

1.75

1792

VITAMINE D3

B.O.N.

Solution for

injection x 200 000

IU/1ml

CHOLECALCIFEROLBox x 1

ampoules x 1ml

BOUCHARA RECORDATI -

FRANCE

HAUPT PHARMA LIVRON -

FRANCE

RIREGJ.

366/23.09.20111.43

1793DEXEF Capsules x 500mg CEFRADINE Box x 12

LABORATOIRES SFDB -

FRANCE

FACTA FARMACEUTICI

S.P.A. - ITALI

REGJ.

358/10.06.2009 2.86

1794

BERES DROPS

PLUS

Oral solution x

(0.025mg +

0.09mg + 0.1mg +

0.11mg + 0.12mg +

0.19mg + 0.25mg +

0.31mg + 0.4mg +

1.14mg + 2mg) / ml

COBALT + FLUORINE +

BORON + NICKEL +

VANADIUM +

MOLYBDENUM + COPPER

+ MANGANESE +

MAGNESIUM + ZINC +

IRON

Box x 1 flacon x

30ml,

BERES

PHARMACEUTICALS CO.

LTD - HUNGARI

BERES PHARMACEUTICALS

CO. LTD - HUNGARI

RIREGJ.

339/03.06.2009

3.1

1795

BERES DROPS

PLUS

Oral solution x

(0.025mg +

0.09mg + 0.1mg +

0.11mg + 0.12mg +

0.19mg + 0.25mg +

0.31mg + 0.4mg +

1.14mg + 2mg) / ml

COBALT + FLUORINE +

BORON + NICKEL +

VANADIUM +

MOLYBDENUM + COPPER

+ MANGANESE +

MAGNESIUM + ZINC +

IRON

Box x 1 flacon x

30ml, 100ml

BERES

PHARMACEUTICALS CO.

LTD - HUNGARI

BERES PHARMACEUTICALS

CO. LTD - HUNGARI

RIREGJ.

339/03.06.2009

8.9

Page 245

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246

1796

ECHINACIN

CAPSETTEN

MADAUS

Lozenges x

88.5mg

DRIED PRESSED JUICE

FROM FRESH FLOWERING

PURPLE CONEFLOWER

[31.5 - 53.6:1]

Box x 40MADAUS GMBH -

GJERMANI

CAPSOID PHARMA GMBH -

GJERMANI

RIREGJ.

282/07.07.2011

8.2

1797

ECHINACIN

TABLETS

MADAUS

Tablets x 100mg

PRESSED JUICE OF

FRESH FLOWERING

PURPLE CONEFLOWER

HERB [22 - 65:1]

Box x 1 glass

bottle x 50

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

282/07.07.2011

7.33

1798

ECHINACIN

LIQUIDUM

MADAUS

Solution x

80g/100g

PRESSED JUICE FROM

FRESH FLOWERING

PURPLE CONEFLOWER

Box x 1 flacon x

50ml

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

470/31.08.2010

5.36

1799

LEGALON

PROTECT

MADAUS

Capsules x 70mg

DRIED EXTRACT OF MILK

THISTLE FRUITS EQ. TO

70mg SILYMARIN (DNPH)

Box x 100 (for

hospital use)

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

446/03.08.2010

22.26

1800

LEGALON FORTE Capsules x 140mg

DRIED EXTRACT OF MILK

THISTLE FRUITS EQ. TO

140mg SILYMARIN (DNPH)

Box x 60MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

446/03.08.2010

27.22

1801

LEGALON FORTE Capsules x 140mg

DRIED EXTRACT OF MILK

THISTLE FRUITS EQ. TO

140mg SILYMARIN (DNPH)

Box x 100 (for

hospital use),

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

446/03.08.2010

39.55

1802

PROSTA

URGENIN UNO

Soft capsules x

320mg

LIPOPHILIC EXTRACT OF

SAW - PALMETTO

BERRIES

Box x 120MADAUS GMBH -

GJERMANI

SCHERER GMBH & CO.KG -

GJERMANI

RIREGJ.

470/31.08.201020.39

1803

REPARIL-GEL NGel x (1g +

5g)/100g

ESCIN + DIETHYLAMINE

SALICYLATE

Box x 1 tube x

100g

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

446/03.08.20106.06

1804SPASMOLYT

Coated tablets x

20mgTROSPIUM CHLORIDE Box x 30

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

282/07.07.2011 13.13

1805SPASMOLYT

Coated tablets x

20mgTROSPIUM CHLORIDE Box x 50

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

RIREGJ.

282/07.07.2011 20.22

1806

URALYT-U Granules x 2.5g

POTASSIUM SODIUM

HYDROGEN CITRATE

2427.7mg

Box x 1 flacon x

280g

MADAUS GMBH -

GJERMANI

PLANTEXTRAKT GMBH &

CO. KG - GJERMANI

RIREGJ.

470/31.08.201029.86

Page 246

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247

1807

AGIOLAX

Granules x [2.6g +

0.11g + (0.34-

0.66g)]/5g

PLANTAGO OVATA SEEDS

+ ISPAGHULA HUSKS +

TINNEVELLY SENNA PODS

Can x 100g MADAUS GMBH -

GJERMANI

MADAUS GMBH -

GJERMANI, MADAUS

PHARMACEUTICALS

PRIVATE LIMITED - INDI

RIREGJ.

332/29.08.2011

2.22

1808

CALCIGEN D Chewable tablets x

(600 mg + 400 I.U.)

CALCIUM (as CALCIUM

CARBONATE x 1500 mg) +

COLECALCIFEROL (as

COLECALCIFEROL

CONCENTRATE x 4 mg)

Box x 50

MADAUS GMBH -

GJERMANIMADAUS GMBH - GJERMANI

Riregj.423/11.07.201

3

7.8

1809AMBROSAN Tablets x 30mg

AMBROXOL

HYDROCHLORIDEBox x 20

PRO.MED. CS PRAHA

A.S. - CEKI

PRO.MED. CS PRAHA A.S. -

CEKI

RIREGJ.

584/29.10.2010 0.95

1810

ROFY

Solution for

injection x

100mg/2ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 2ml

CODAL SYNTO LTD -

QIPROMEDOCHEMIE LTD - QIPRO REGJ. 3/07.01.2013

2.95

1811

AMIKA-SYNTO

Solution for

injection x

500mg/2ml vial

AMIKACIN (as AMIKACIN

SULPHATE)

Box x 100 vials

(for hospital

use)

CODAL SYNTO LTD -

QIPRO

ANFARM HELLAS SA -

GREQIREGJ. 88/16.02.2010

82

1812

SYNTOXIME

Powder for

injection/infusion x

1g/vial

CEFOTAXIME SODIUM EQ.

TO 1g CEFOTAXIME

Box x 100 vials

(for hospital use

only)

CODAL SYNTO LTD -

QIPROMEDOCHEMIE LTD - QIPRO

RIREGJ.

583/29.10.2010

90

1813

PROTRADONHard-gelatine

capsules x 50mg

TRAMADOL

HYDROCHLORIDEBox x 10

PRO.MED. CS PRAHA

A.S. - CEKI

PRO.MED. CS PRAHA A.S. -

CEKI

RIREGJ.

583/29.10.20101.59

1814

PROTRADONHard-gelatine

capsules x 50mg

TRAMADOL

HYDROCHLORIDE Box x 20

PRO.MED. CS PRAHA

A.S. - CEKI

PRO.MED. CS PRAHA A.S. -

CEKI

RIREGJ.

583/29.10.20103.15

1815

ANCOPIR

Solution for

injection x (1mg +

50mg + 200mg +

10mg)/2ml

CYANOCOBALAMIN +

PYRIDOXINE

HYDROCHLORIDE +

THIAMINE

HYDROCHLORIDE +

LIDOCAINE

HYDROCHLORIDE

Box x 5

ampoules

DR. GROSSMANN AG

PHARMACA - ZVICER

WULFING PHARMA GMBH -

GJERMANI, SOLUPHARM

PHARMAZEUTISCHE

ERZEUGNISSE GMBH -

GJERMANI, DR.

GROSSMANN AG

PHARMACA - ZVICER

REGJ.

184/18.03.2009

3.85

Page 247

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248

1816

ANCOPIRDragees x (0.3mg

+ 100mg + 200mg)

CYANOCOBALAMIN +

PYRIDOXINE

HYDROCHLORIDE +

THIAMINE NITRATE

Box x 20DR. GROSSMANN AG

PHARMACA - ZVICER

DR. GROSSMANN AG

PHARMACA - ZVICER

REGJ.

184/18.03.2009

3

1817

RHINOCAPCapsules x (10mg

+ 20mg + 25mg)

DIMENHYDRINATE +

PHENYLEPHRINE

HYDROCHLORIDE +

CAFFEINE

Box x 10DR. GROSSMANN AG

PHARMACA - ZVICER

DR. GROSSMANN AG

PHARMACA - ZVICER,

OSMOPHARM SA - ZVICER

RIREGJ.

332/29.08.2011

1.8

1818

RAMICOMP

GENERICON

Tablets x (5mg +

25mg)

RAMIPRIL +

HYDROCHLOROTHIAZIDEBox x 30

GENERICON PHARMA

GMBH - AUSTRI

ACTAVIS HF - ISLANDE;

ACTAVIS LTD - MALTE; GE

PHARMACEUTICALS LTD -

BULLGARI; GL PHARMA

GMBH - AUSTRI;

GENERICON PHARMA

GESELLSCHAFT M.B.H. -

AUSTRI

RIREGJ.

50/04.02.2013

5.4

1819

ROXITHROMYCIN

GENERICON

Film-coated tablets

x 150mgROXITHROMYCIN Box x 12

GENERICON PHARMA

GMBH - AUSTRI

ZENTIVA SAGLIK URUNLERI

SAN. VE TIC. AS - TURQI; GL

PHARMA GMBH - AUSTRI;

GENERICON PHARMA

GESELLSCHAFT M.B.H -

AUSTRI

RIREGJ.

417/10.09.2012

4.3

1820

ROXITHROMYCIN

GENERICON

Film-coated tablets

x 300mgROXITHROMYCIN Box x 7

GENERICON PHARMA

GMBH - AUSTRI

ZENTIVA SAGLIK URUNLERI

SAN. VE TIC. AS - TURQI; GL

PHARMA GMBH - AUSTRI;

GENERICON PHARMA

GESELLSCHAFT M.B.H -

AUSTRI

RIREGJ.

417/10.09.2012

6

Page 248

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249

1821

LISINOCOMP

GENERICON

Tablets x (20mg +

25mg)

LISINOPRIL +

HYDROCHLORTHIAZIDEBox x 30

GENERICON PHARMA

GMBH - AUSTRI

GENERICON PHARMA

GESELLSCHAFT M.B. H. -

AUSTRI; GE

PHARMACEUTICALS LTD -

BULLGARI; ACTAVIS HF -

ISLANDE; ACTAVIS LTD -

MALTE; GL PHARMA GMBH -

AUSTRI

RIREGJ.

325/15.05.2013

7

1822

LISINOCOMP

GENERICON MITE

Tablets x (20mg +

12.5mg)

LISINOPRIL +

HYDROCHLORTHIAZIDEBox x 30

GENERICON PHARMA

GMBH - AUSTRI

GENERICON PHARMA

GESELLSCHAFT M.B. H. -

AUSTRI; GE

PHARMACEUTICALS LTD -

BULLGARI; ACTAVIS HF -

ISLANDE; ACTAVIS LTD -

MALTE; GL PHARMA GMBH -

AUSTRI

RIREGJ.

325/15.05.2013

5.5

1823

RAMIPRIL

GENERICONTablets x 5mg RAMIPRIL Box x 30

GENERICON PHARMA

GMBH - AUSTRI

ACTAVIS LTD - MALTE; GE

PHARMACEUTICALS LTD -

BULLGARI; GL PHARMA

GMBH - AUSTRI;

GENERICON PHARMA

GESELLSCHAFT M.B.H. -

AUSTRI

RIREGJ.

50/04.02.2013

3.5

1824

RAMIPRIL

GENERICONTablets x 10mg RAMIPRIL Box x 30

GENERICON PHARMA

GMBH - AUSTRI

ACTAVIS LTD - MALTE; GE

PHARMACEUTICALS LTD -

BULLGARI; GL PHARMA

GMBH - AUSTRI;

GENERICON PHARMA

GESELLSCHAFT M.B.H. -

AUSTRI

RIREGJ.

50/04.02.2013

4.8

Page 249

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250

1825

RAMICOMP

GENERICON

Tablets x (2.5mg +

12.5mg)

RAMIPRIL +

HYDROCHLOROTHIAZIDEBox x 30

GENERICON PHARMA

GMBH - AUSTRI

ACTAVIS HF - ISLANDE;

ACTAVIS LTD - MALTE; GE

PHARMACEUTICALS LTD -

BULLGARI; GL PHARMA

GMBH - AUSTRI;

GENERICON PHARMA

GESELLSCHAFT M.B.H. -

AUSTRI

RIREGJ.

50/04.02.2013

3.8

1826

BICALUTAMID

"GENERICON"

Film coated tablet x

50mgBICALUTAMIDE Box x 30

GENERICON PHARMA

GMBH - AUSTRI

SYNTHON HISPANIA S.L. -

SPANJE, SYNTHON BV -

HOLLANDE, QUINTA-

ANALYTICA SRO - CEKI,

MPF BV - HOLLANDE,

BUDELPACK HAMONT

SA/NV - BELGJIKE,

GENERICON PHARMA

GESELLSCHAFT.M.B.H. -

AUSTRI

REGJ.

192/19.03.2009

43.64

1827

BICALUTAMID

"GENERICON"

Film coated tablet x

150mgBICALUTAMIDE Box x 30

GENERICON PHARMA

GMBH - AUSTRI

SYNTHON HISPANIA S.L. -

SPANJE, SYNTHON BV -

HOLLANDE, QUINTA-

ANALYTICA SRO - CEKI,

MPF BV - HOLLANDE,

BUDELPACK HAMONT

SA/NV - BELGJIKE,

GENERICON PHARMA

GESELLSCHAFT.M.B.H. -

AUSTRI

REGJ.

192/19.03.2009

98.35

1828

DOXAZOSIN

"GENERICON" Tablets x 2 mg

DOXAZOSIN (as

DOXAZOSIN MESILATE x

2.425 mg)

Box x 30 "GENERICON PHARMA

GMBH" AUSTRI

"ARENA

PHARMACEUTICALS GMBH"

ZVICER; "SIEGFRED MALTA

LTD" MALTE

Riregj.458/19.08.201

3

5.8

Page 250

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251

1829

DOXAZOSIN

"GENERICON" Tablets x 4 mg

DOXAZOSIN (as

DOXAZOSIN MESILATE x

4.85 mg)

Box x 30 "GENERICON PHARMA

GMBH" AUSTRI

"ARENA

PHARMACEUTICALS GMBH"

ZVICER; "SIEGFRED MALTA

LTD" MALTE

Riregj.458/19.08.201

3

6.5

1830

LISINOCOMP

GENERICON SEMI

Tablets x (10mg +

12.5mg)

LISINOPRIL +

HYDROCHLORTHIAZIDEBox x 30

GENERICON PHARMA

GMBH - AUSTRI

GENERICON PHARMA

GESELLSCHAFT M.B. H. -

AUSTRI; GE

PHARMACEUTICALS LTD -

BULLGARI; ACTAVIS HF -

ISLANDE; ACTAVIS LTD -

MALTE; GL PHARMA GMBH -

AUSTRI

RIREGJ.

325/15.05.2013

4

1831

PANTHRONEnteric-coated

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.4mg)

Box x 30

ERIS

PHARMACEUTICALS

(AUSTRALIA) PTY LTD -

AUSTRALI

IPCA LABORATORIES LTD -

INDI; PHARMAPAK

TECHNOLOGIES PTY LTD -

AUSTRALI

REGJ.

205/20.05.2011

10.5

1832

CALCIPROX Capsules x 0.25µg CALCITRIOLBox x plastic

bottle x 100

ERIS

PHARMACEUTICALS

(AUSTRALIA) PTY LTD -

AUSTRALI

PHARMAPAK

TECHNOLOGIES PTY LTD -

AUSTRALI; STRIDES

ARCOLAB LIMITED - INDI

REGJ.

205/20.05.2011

10

1833

JENE-35 EDTablets x (2mg +

35µg)

CYPROTERONE ACETATE

+ ETHINYLOESTRADIOL

Box x 28 (21

yellow tablets +

7 white tablets)

ERIS

PHARMACEUTICALS

(AUSTRALIA) PTY LTD -

AUSTRALI

DOUGLAS

MANUFACTURING LTD -

ZELANDA E RE

REGJ.

205/20.05.2011

4.5

1834

DERMATANE Capsules x 20mg ISOTRETIONIN Box x 60

ERIS

PHARMACEUTICALS

(AUSTRALIA) PTY LTD -

AUSTRALI

DOUGLAS

MANUFACTURING LTD -

ZELANDA E RE

REGJ. 61/06.02.2013

25

Page 251

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252

1835

BEVIPLEX

Lyophilizate for

solution for

injection with

solvent for

parenteral use x

(40mg + 4mg +

8mg + 100mg +

10mg +

0.004mg)/ampoule

THIAMINE

HYDROCHLORIDE +

RIBOFLAVINE SODIUM

PHOSPHATE +

PYRIDOXINE

HYDROCHLORIDE +

NICOTINAMIDE + CALCIUM

PANTOTHENATE +

CYANOCOBALAMIN

Box x 5

ampoules of

lyophilizate + 5

ampoules of

solvent (water

for injection) x

2ml

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 21/13.01.2011

3.5

1836

CHLORAMPHENIC

OL

Eye ointment x

10mg/gCHLORAMPHENICOL

Box x 1 tube x

5g

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 21/13.01.2011

0.65

1837

ENBECINEye ointment x

(500IU + 3.30mg)/g

BACITRACIN + NEOMYCIN

(as NEOMYCIN SULPHATE)

Box x 1 tube x

5g

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 21/13.01.2011

0.75

1838

GLIORAL Tablets x 80mg GLICLAZIDE Box x 30GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 74/01.03.2011

1.3

1839

HYDROCYCLINOintment x (1% +

3%) w/w

HYDROCORTISONE +

OXYTETRACYCLINE

HYDROCHLORIDE

Box x 1 tube x

20g, Box x 1

tube x 5g

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 74/01.03.2011

1.3

1840

LIDOKAIN

HLORID 1%

Solution for

injection x

35mg/3.5ml

LIDOCAINE

HYDROCHLORIDE (as

LIDOCAINE

HYDROCHLORIDE

MONOHYDRATE)

Box x 10

ampoules x

3.5ml

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 21/13.01.2011

4

1841

LONGACEPH

Powder for solution

for injection x

1g/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM)

Box x 10 vials

(for hospital

use)

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 74/01.03.2011

15

1842

SINODERM Cream x 0.25mg/gFLUOCINOLONE

ACETONIDE

Box x 1 tube x

15g

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISEREGJ. 45/30.01.2012

0.7

1843

SINODERMOintment x

0.25mg/g

FLUOCINOLONE

ACETONIDE

Box x 1 tube x

15g

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISE

REGJ.

140/15.04.20110.7

Page 252

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253

1844

SINODERM Gel x 0.25mg/gFLUOCINOLONE

ACETONIDE

Box x 1 tube x

30g

GALENIKA A.D. -

REPUBLIKA E SERBISE

GALENIKA A.D. - REPUBLIKA

E SERBISE

REGJ.

140/15.04.20111

1845

MILDRONATE

0.5g/5ml

Solution for

injection x

500mg/5ml

MELDONIUMBox x 10

ampoules x 5mlAS GRINDEKS - LETONI

AB SANITAS - LITUANI; HBM

PHARMA SRO - REPUBLIKA

SLLOVAKE

REGJ.

534/15.10.20098.2

1846

MILDRONATE

250mg

Hard capsules x

250mgMELDONIUM Box x 60 AS GRINDEKS - LETONI AS GRINDEKS - LETONI

REGJ.

534/15.10.2009 8.3

1847

MILDRONATE

500mg

Hard capsules x

500mgMELDONIUM Box x 60 AS GRINDEKS - LETONI AS GRINDEKS - LETONI

REGJ.

534/15.10.2009 13

1848

FTORAFUR

400mg

Hard capsules x

400mgTEGAFUR Box x 100 AS GRINDEKS - LETONI AS GRINDEKS - LETONI

REGJ.

534/15.10.2009 85

1849

CAPSICAM

Ointment x (50mg

+ 30mg + 30mg +

20mg + 2mg)/g

DIMETHYL SULFOXIDE +

CAMPHOR + TURPENTINE

OIL + BENZYL NICOTINATE

+ NONIVAMIDE

Box x 1 tube x

30gAS GRINDEKS - LETONI

TALLINNA

FARMAATSIATEHASE AS -

ESTONI

REGJ.

534/15.10.2009

2.66

1850VENLAXOR Tablets x 37.5mg VENLAFAXINE Box x 30 AS GRINDEKS - LETONI AS GRINDEKS - LETONI

REGJ.

420/13.10.2011 3

1851VENLAXOR Tablets x 75mg VENLAFAXINE Box x 30 AS GRINDEKS - LETONI AS GRINDEKS - LETONI

REGJ.

420/13.10.2011 5

1852SOMNOLS

Film-coated tablets

x 7.5mgZOPICLON Box x 30 AS GRINDEKS - LETONI AS GRINDEKS - LETONI

REGJ.

420/13.10.2011 3.4

1853

TERBITAL Cream x 10mg/gTERBINAFINE

HYDROCHLORIDE

Box x tube x

15gAS GRINDEKS - LETONI

TALLINNA

FARMAATSIATEHASE AS -

ESTONI

REGJ.

420/13.10.20113

1854

AZITROFilm tablets x

500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 542.30mg)

Box x 3DEVA HOLDING AS -

TURQIDEVA HOLDING AS - TURQI

REGJ.

664/21.12.2010

4.2

1855

AMOKLAVIN BID

200/28MG

Powder for oral

suspension x

(200mg +

28mg)/5ml

AMOXICILLIN x 4.0g/100ml

(as AMOXICILLIN

TRIHYDRATE x

4.646g/100ml) +

CLAVULANIC ACID x

0.570)/100ml (as

POTASSIUM

CLAVULANATE x

1.433g/100ml)

Box x glass

bottle x 100ml

DEVA HOLDING AS -

TURQIDEVA HOLDING AS - TURQI

REGJ.

588/29.10.2010

3.6

Page 253

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254

1856

CEFAKSFilm tablets x

250mg

CEFUROXIME (as

CEFUROXIME AXETIL x

306.100mg)

Box x 10DEVA HOLDING AS -

TURQIDEVA HOLDING AS - TURQI

REGJ.

664/21.12.20106

1857

CEFAKSFilm tablets x

500mg

CEFUROXIME (as

CEFUROXIME AXETIL x

612.20mg)

Box x 10DEVA HOLDING AS -

TURQIDEVA HOLDING AS - TURQI

REGJ.

664/21.12.201010

1858

DEGASTROL Capsules x 15mg LANSOPRAZOLEBox x 1 plastic

bottle x 28

DEVA HOLDING AS -

TURQI

DEVA ILAC SAN. VE TIC. AS -

TURQI

REGJ.

664/21.12.20106

1859

DEGASTROL Capsules x 30mg LANSOPRAZOLEBox x 1 plastic

bottle x 14

DEVA HOLDING AS -

TURQI

DEVA ILAC SAN. VE TIC. AS -

TURQI

REGJ.

664/21.12.20105.5

1860

CITOLESFilm-coated tablets

x 10mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

x 12.775mg)

Box x 28ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

452/31.10.20118

1861

CITOLESFilm-coated tablets

x 20mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

x 25.55mg)

Box x 28ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

452/31.10.201113

1862

DEMAXFilm-coated tablets

x 10mg

MEMANTINE

HYDROCHLORIDE

Box x 30

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

208/07.05.2012;

VARIACION NR.585

DT.10.10.201224

1863

DEMAXOral drops solution

x 10mg/g

MEMANTINE

HYDROCHLORIDE

Box x 1 bottle x

100g

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ. 433/1 Dt.

28.09.201260

1864

ONCEAIRChewable tablets x

4mg

MONTELUKAST (as

MONTELUKAST SODIUM x

4.16mg)

Box x 28ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

208/07.05.201215

1865

ONCEAIRChewable tablets x

5mg

MONTELUKAST (as

MONTELUKAST SODIUM x

5.2mg)

Box x 28ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

208/07.05.201215

1866

ONCEAIRFilm-coated tablets

x 10mg

MONTELUKAST (as

MONTELUKAST SODIUM x

10.4mg)

Box x 28ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

208/07.05.201219

1867

ORNISID Film-coated tablets

x 250mgORNIDAZOLE Box x 20

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

140/19.03.20138

Page 254

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255

1868

ORNISID FORTFilm-coated tablets

x 500mgORNIDAZOLE Box x 10

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

140/19.03.20138

1869

ORNISID Vaginal tablets x

500mgORNIDAZOLE Box x 3

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

140/19.03.20135

1870

PARKYN Tablets x 0.25mg

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE (eq. to

PRAMIPEXOLE x 0.18mg)

Box x 100 (for

hospital use)

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ. 433/1 Dt.

28.09.2012

10

1871

PARKYN Tablets x 1mg

PRAMIPEXOLE

DIHYDROCHLORIDE

MONOHYDRATE (eq. to

PRAMIPEXOLE x 0.7mg)

Box x 100 (for

hospital use)

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ. 433/1 Dt.

28.09.2012

20

1872

RISONEL

Nasal spray,

suspension x

0.05%

MOMETASONE FUROATE

(as MOMETASONE

FUROATE MONOHYDRATE

x 0.518mg/g)

Box x plastic

bottle x 18g x

140 doses

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

208/07.05.2012

6

1873

VASOSERC Tablets x 8mgBETAHISTINE

DIHYDROCHLORIDEBox x 30

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

452/31.10.20111.5

1874

VASOSERC

FORTETablets x 16mg

BETAHISTINE

DIHYDROCHLORIDEBox x 30

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

452/31.10.20116

1875

VASOSERC BID Tablets x 24mgBETAHISTINE

DIHYDROCHLORIDEBox x 30

ABDI IBRAHIM ILAC SAN.

VE TIC. AS - TURQI

ABDI IBRAHIM ILAC SAN. VE

TIC. AS - TURQI

REGJ.

452/31.10.201110

1876

MOXAI

Solution for

infusion x

400mg/250ml

MOXIFLOXACIN (as

MOXIFLOXACIN

HYDROCHLORIDE x

436.8mg/250ml)

Box x 1 bottle x

250ml

"ABDI IBRAHIM ILAC SAN.

VE TIC. A.S." TURQI

"MEFAR ILAC SAN. A.S."

TURQI

Regj.

384/ 17.06.2013

39

1877

A-FERIN HOTGranules x (500mg

+ 60mg)/ sachet

PARACETAMOL +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 10

sachets x 6g

granules

HUSNU ARSAN ILACLARI

AS TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQIREGJ. 61/06.02.2013

2.2

Page 255

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256

1878

A-FERIN PLUSFilm-coated tablets

x (650mg + 4mg)

PARACETAMOL +

CHLORPHENIRAMINE

MALEATE Box x 30

HUSNU ARSAN ILACLARI

AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI Regj.422/11.07.2013

2

1879

A-FERIN PLUS

Pediatric syrup x

(3.2g + 0.3g +

0.02g)/100ml

PARACETAMOL +

PSEUDOEPHEDRINE

HYDROCHLORIDE +

CHLORPHENIRAMINE

MALEATE

Box x 1 glass

bottle x 100ml

HUSNU ARSAN ILACLARI

AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

452/31.10.2011

1.5

1880

ASIST 4%Granules for syrup

x 4 g / 100mlACETYLCYSTEINE

Box x 1 bottle x

100 ml

HUSNU ARSAN ILACLARI

A.S. - TURQI

BILIM ILAC SANAYII VE

TICARET A.S. - TURQI

RIREGJ. 433/2 Dt.

28.09.20122.2

1881

ASIST 4%Granules for syrup

x 6 g / 150mlACETYLCYSTEINE

Box x 1 bottle x

150 ml

HUSNU ARSAN ILACLARI

A.S. - TURQI

BILIM ILAC SANAYII VE

TICARET A.S. - TURQI

RIREGJ. 433/2 Dt.

28.09.20122.5

1882

ASIST PLUS

Powder for oral

solution x 600mg/

sachet

ACETYLCYSTEINEBox x 30

sachets

HUSNU ARSAN ILACLARI

AS TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

307/07.05.20136

1883

ATEROZFilm Coated

Tablets x 40mg

ATORVASTATIN (as

ATORVASTATIN CALCIUM

x 41.35mg)

Box x 30BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

445/03.08.20109

1884

ATEROZFilm Coated

Tablets x 80mg

ATORVASTATIN (as

ATORVASTATIN CALCIUM

x 82.70mg)

Box x 30BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

445/03.08.201015

1885

CEFTINEXFilm coated tablets

x 300mgCEFDINIR Box x 10

BILIM ILAC SANAYII VE

TICARET AS - TURQI

PHARMAVISION SANAYII VE

TICARET AS - TURQI

REGJ.

422/12.09.201212

1886

CEFTINEX

Powder for oral

suspension x

125mg/5 ml

CEFDINIRBox x 1glass

bottle x 100ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

PHARMAVISION SANAYII VE

TICARET AS - TURQI

REGJ.

422/12.09.20128

1887

ENFEXIAFilm coated tablets

x 500mg

CEFUROXIME (AS

CEFUROXIME AXETIL x

601.44 mg)

Box x 10BILIM ILAC SANAYII VE

TICARET A.S. - TURQI

PHARMA VISION SANAYII VE

TICARET A.S. - TURQI

RIREGJ. 433/2 Dt.

28.09.201210

1888

FERIMAX

Solution for I.M.

injection x

100mg/2ml

ELEMENTARY IRON (as

IRON III HYDROXIDE

POLYMALTOSE COMPLEX

x 333.33mg/ampoule)

Box x 5

ampoules x 2ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

IDOL ILAC DOLUM SAN. VE

TIC. AS - TURQI

REGJ.

445/03.08.2010

5

Page 256

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257

1889

FERIMAXOral solution x

100mg/5ml

ELEMENTARY IRON (as

IRON III HYDROXIDE

POLYMALTOSE COMPLEX

0.333g/vial)

Box x 10 flacons

x 5ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

"IDOL ILAC DOLUM SAN. VE

TIC. AS" TURQIRegj.422/11.07.2013

6.5

1890

FERIMAXSyrup x

1500mg/bottle

ELEMENTARY IRON (as

IRON III HYDROXIDE

POLYMALTOSE COMPLEX

x 5.00g/bottle)

Box x 1 glass

bottle x 150ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

457/06.08.2010

3

1891

FORSEF

Powder and

solvent for solution

for I.V injection x

1g/vial

CEFRIAXONE (as

CEFTRIAXONE DISODIUM

3 1/2 H2O x 1.193g/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent x 10ml

BILIM ILAC SANAYI VE

TICARET AS - TURQI

PHARMAVISION SAN. VE

TIC. AS - TURQI

RIREGJ.

336/20.07.2012

2.6

1892

FORSEF

Powder and

solvent for solution

for I.M injection x

1g/vial

CEFRIAXONE (as

CEFTRIAXONE DISODIUM

3 1/2 H2O x 1.193g/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent

(Lidocaine

hydrochloride

1%) x 4ml

BILIM ILAC SANAYI VE

TICARET AS - TURQI

PHARMAVISION SAN. VE

TIC. AS - TURQI

RIREGJ.

336/20.07.2012

3.2

1893

FORTINEFilm coated tablets

x 100mgFLURBIPROFEN Box x 15

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

422/12.09.20123

1894

GLIFIX Tablets x 15mg

PIOGLITAZONE (as

PIOGLITAZONE HCL x

16.7mg)

Box x 30BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.20096

1895

GLIFIX Tablets x 30mg

PIOGLITAZONE (as

PIOGLITAZONE HCL x

33.4mg)

Box x 30BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.20099

1896

GLIFIX Tablets x 45mg

PIOGLITAZONE (as

PIOGLITAZONE HCL x

50mg)

Box x 30BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.200912

1897

KETORALMedical shampo x

2g/100mlKETOCONAZOLE

Box x 1 bottle x

100ml

BILIMC ILAC SANAYI VE

TICARET A.S. - TURQI

ZENTIVA SAGLIK URUNLERI

SAN. VE TIC. AS - TURQI

REGJ.

307/07.05.20134.5

1898

KETORAL

Vaginal

supositories x

400mg

KETOCONAZOLE

(micronised)Box x 3

"BILIM ILAC SANAYI VE

TICARET A.S." TURQI

"BIOFARMA ILAC SANAYI VE

TICARET A.S." TURQI

Regj.

384/ 17.06.20134

Page 257

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258

1899

LARGOPEN BID

400MG FORT

Powder for oral

suspension x

8g/per unit dose

AMOXICILLIN (as

AMOXICILLIN TRIHYDRATE

x 9.185g/per unit dose)

Box x 1 glass

bottle x 100ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.2009

2

1900

LOSIRAMFilm - coated

tablets x 10mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

X 12.78mg)

Box x 28BILIMC ILAC SANAYI VE

TICARET A.S. - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ.

307/07.05.20136

1901

LOSIRAMFilm - coated

tablets x 20mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

X 12.78mg)

Box x 28BILIMC ILAC SANAYI VE

TICARET A.S. - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ.

307/07.05.201310

1902

METSIL DROPSOral drops, solution

x 2g/30mlSIMETHICONE (66.6mg/ml)

Box x 1 flacon x

30ml

HUSNU ARSAN ILACLARI

AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

RIREGJ.

351/31.07.20123

1903METSIL FORT

Chewable tablets x

80mgSIMETHICONE Box x 50

HUSNU ARSAN ILACLARI

AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

RIREGJ.

351/31.07.2012 3

1904

MUSCOFLEX Capsules x 4mg THIOCOLCHICOSIDE Box x 20BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.20098

1905

MUSCOFLEX Cream x 0.25%THIOCOLCHICOSIDE

(0.075g/tube)

Box x tube x

30g

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.20095

1906

MUSCOFLEXSolution for I.M

injection x 4mg/2mlTHIOCOLCHICOSIDE

Box x 6

ampoules x 2ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

IDOL ILAC DOLUM SAN. VE

TIC. AS - TURQI

REGJ.

733/28.12.20096

1907

SEKROL Tablets x 30mgAMBROXOL

HYDROCHLORIDEBox x 20

BILIM ILAC SANAYI VE

TICARET AS - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ.

646/10.12.20101.6

1908

SEKROL Pediatric Syrup x

15mg/5ml

AMBROXOL

HYDROCHLORIDE x

0.450g/bottle

Box x 1 bottle x

150ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQIREGJ. 98/22.02.2010

2

1909

SPAZMOTEK

Solution for I.V/I.M

sc. injection x

20mg/1ml

HYOSCINE N-

BUTYLBROMIDE

Box x 6

ampoules x 1ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

IDOL ILAC DOLUM SAN. VE

TIC. AS - TURQI

REGJ.

418/12.10.2011

3

1910

SPAZMOTEK

PLUS

Film-coated tablets

x (500mg + 10mg)

PARACETAMOL +

HYOSCINE N-

BUTYLBROMIDE

Box x 20BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

452/31.10.20113.5

Page 258

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259

1911

TERBONILE Cream x 1%

TERBINAFINE

HYDROCHLORIDE

(micronised) x 150.0mg/tube

Box x 1 tube x

15g

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

646/10.12.2010

2.8

1912

TERBONILESpray solution x

1%

TERBINAFINE

HYDROCHLORIDE x

0.30g/bottle

Box x 1 spray

plastic bottle x

30ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

646/10.12.20104.5

1913

TRAVAZOLCream x (0.15g +

0.015g)/tube

ISOCONAZOLE NITRATE +

DIFLUCORTOLONE

VALERATE

Box x 1 tube x

15g

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

457/06.08.2010

3.4

1914

ULCOREKSEnteric coated film

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.1mg)

Box x bottle x

28

BILIM ILAC SANAYI VE

TICARET AS - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ.

646/10.12.2010

9.5

1915

ZELOXIM

Solution for I.M

injection x

15mg/1.5ml

MELOXICAM

Box x 3

ampoules x

1.5ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

IDOL ILAC DOLUM SAN. VE

TIC. AS - TURQI

REGJ.

733/28.12.20091.75

1916

ZELOXIM Tablets x 7.5mg MELOXICAM Box x 10BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.20092

1917

ZELOXIM FORT Tablets x 15mg MELOXICAM Box x 10BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.20094.75

1918

ZESPIRAChewable tablets x

4mg

MONTELUKAST (as

MONTELUKAST SODIUM x

4.16mg)

Box x 28BILIM ILAC SANAYI VE

TICARET AS - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ. 433/1 Dt.

28.09.20125

1919

ZESPIRAChewable tablets x

5mg

MONTELUKAST (as

MONTELUKAST SODIUM x

5.2mg)

Box x 28BILIM ILAC SANAYI VE

TICARET AS - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ. 433/1 Dt.

28.09.20126

1920

ZESPIRAFilm-coated tablets

x 10mg

MONTELUKAST (as

MONTELUKAST SODIUM x

10.4mg)

Box x 28BILIM ILAC SANAYI VE

TICARET AS - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ. 433/1 Dt.

28.09.201210

1921

ZIMAKS

Powder for oral

suspension x

100mg/5ml

CEFIXIME Box x 1 bottle x

50ml

BILIM ILAC SANAYI VE

TICARET AS - TURQI

PHARMAVISION SAN. VE

TIC. AS - TURQI

RIREGJ.

336/20.07.20126.5

1922

ZIMAKSFilm-coated tablets

x 400mgCEFIXIME Box x 5

BILIM ILAC SANAYI VE

TICARET AS - TURQI

PHARMAVISION SAN. VE

TIC. AS - TURQI

RIREGJ.

336/20.07.20128.5

Page 259

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260

1923

ULCOREKSEnteric coated film

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.1mg)

Box x bottle x

14

BILIM ILAC SANAYI VE

TICARET AS - TURQI

BILIM ILAC SANAYI VE

TICARET AS - TURQI

REGJ.

646/10.12.2010

7

1924

SIPROGUT 0.3%Ear drops, solution

x 15mg/5ml

CIPROFLOXACIN (as

CIPROFLOXACIN

HYDROCHLORIDE

MONOHYDRATE x

17.5mg/5ml)

Box x 1 vial x

5ml

"BILIM ILAC SANAYI VE

TICARET A.S." TURQI

"MEFAR ILAC SAN. A.S."

TURQI

Regj.

384/ 17.06.2013

3.5

1925REKONAZOL Cream x 20 mg/g KETOCONAZOLE

Box x 1 tube x

30g

REPLEK FARMA LTD -

SKOPJE - MAQEDONI

REPLEK FARMA LTD -

SKOPJE - MAQEDONI

REGJ.

604/27.11.2012 2.2

1926

ORALSEPTOromucosal spray,

solution x 1.5mg/mlBENZYDAMINE

Box x 1 plastic

metered dose

container with

30 ml

oromucosal

spray

REPLEK FARMA LTD -

SKOPJE - MAQEDONI

REPLEK FARMA LTD -

SKOPJE - MAQEDONI

REGJ.

604/27.11.2012

1.9

1927

PARAFEN

Film - coated

tablets x (200mg +

500mg)

IBUPROFEN +

PARACETAMOL POWDERBox x 10,

REPLEK FARM - SKOPJE -

MAQEDONI

REPLEK FARM SKOPJE -

MAQEDONI

REGJ.

307/07.05.2013

1.2

1928

PARAFEN

Film - coated

tablets x (200mg +

500mg)

IBUPROFEN +

PARACETAMOL POWDER, Box x 20

REPLEK FARM - SKOPJE -

MAQEDONI

REPLEK FARM SKOPJE -

MAQEDONI

REGJ.

307/07.05.2013

1.8

1929

VITAMIN C Tablets x 500mg

ASCORBIC ACID (as

ASCORBIC ACID 97% DC

GRANULATE x 515.50mg)

Box x 250 (for

hospital use)

REPLEK FARM LTD -

SKOPJE - MAQEDONI

REPLEK FARM LTD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

307/07.05.2013

7

1930

VITAMIN C Tablets x 500mg

ASCORBIC ACID (as

ASCORBIC ACID 97% DC

GRANULATE x 515.50mg)

Box x 60REPLEK FARM LTD -

SKOPJE - MAQEDONI

REPLEK FARM LTD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

307/07.05.2013

0.9

1931

VITAMIN C Tablets x 500mg

ASCORBIC ACID (as

ASCORBIC ACID 97% DC

GRANULATE x 515.50mg)

Box x 30REPLEK FARM LTD -

SKOPJE - MAQEDONI

REPLEK FARM LTD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

307/07.05.2013

0.3

Page 260

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261

1932

NORLEVO Tablets x 1.5mg LEVONORGESTREL Box x 1LABORATOIRE HRA

PHARMA - FRANCE

OSNY PHARMA SAS -

FRANCE; DELPHARM LILLE

SAS - FRANCE

REGJ.

527/01.10.20103.82

1933

ALVENTA 37.5

Prolonged-release

capsules, hard x

37.5 mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

580/27.10.2008

5

1934

ALVENTA 75

Prolonged-release

capsules, hard x 75

mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

580/27.10.2008

10

1935

ALVENTA 150

Prolonged-release

capsules, hard x

150 mg

VENLAFAXINE (as

VENLAFAXINE

HYDROCHLORIDE)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

580/27.10.2008

16

1936AMPRIL Tablets x 1.25mg RAMIPRIL Box x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

166/19.04.2012 1.55

1937AMPRIL Tablets x 2.5mg RAMIPRIL Box x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

166/19.04.2012 1.29

1938AMPRIL Tablets x 5mg RAMIPRIL Box x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

166/19.04.2012 2.26

1939AMPRIL Tablets x 10mg RAMIPRIL Box x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

166/19.04.2012 2.37

1940

AMPRIL HDTablets x (5mg +

25mg)

RAMIPRIL +

HYDROCHLOROTHIAZIDEBox x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

166/19.04.20125.5

1941

AMPRIL HLTablets x (2.5mg +

12.5mg)

RAMIPRIL +

HYDROCHLOROTHIAZIDEBox x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

166/19.04.20123.95

1942APAURIN

Coated tablets x

2mgDIAZEPAM Box x 30

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

647/10.12.2010 0.45

1943APAURIN Tablets x 10mg DIAZEPAM Box x 30

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

647/10.12.2010 1.13

1944

ASENTRAFilm - coated

tablets x 50mg

SERTRALINE (as

SERTRALINE

HYDROCHLORIDE x

55.95mg)

Box x 28KRKA D.D. NOVO MESTO

- SLLOVENI

KRKA D.D. NOVO MESTO -

SLLOVENI

RIREGJ.

325/15.05.2013

2.66

Page 261

Page 262: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

262

1945

ASENTRAFilm - coated

tablets x 100mg

SERTRALINE (as

SERTRALINE

HYDROCHLORIDE x

111.9mg)

Box x 28KRKA D.D. NOVO MESTO

- SLLOVENI

KRKA D.D. NOVO MESTO -

SLLOVENI

RIREGJ.

325/15.05.2013

5.21

1946

ATORISFilm coated tablets

x 40mg

ATORVASTATIN AS

ATORVASTATIN CALCIUM

x 41.44mg

Box x 30; KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

372/27.09.20113.5

1947

AZIBIOTFilm coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE)

Box x 3

KRKA, TOVARNA

ZDRAVIL, D.D -

SLLOVENI

KRKA, TOVARNA ZDRAVIL,

D.D - SLLOVENI

REGJ.

421/29.07.20094.5

1948

B-COMPLEX

Coated tablets x

(4mg + 5mg + 2mg

+ 1µg + 5mg +

25mg + 20mg)

THIAMINE

HYDROCHLORIDE +

RIBOFLAVIN +

PYRIDOXINE

HYDROCHLORIDE +

CYANOCOBALAMIN +

CALCIUM PANTOTHENATE

+ NICOTINAMIDE + PARA-

AMINOBENZOIC ACID

Box x 30KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

REGJ.

733/28.12.2009

1.33

1949BILOBIL FORTE

Hard capsules x

80mg

GINKGO LEAF DRY

EXTRACT (35-67:1)Box x 20, 60

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010 2.93

1950

BILOBILHard capsules x

40mg

DRY, REFINED AND

QUANTIFIED EXTRACT

FROM GINKGO LEAF

(GINKGO BILOBA L.,

FOLIUM) (35-67:1)

Box x 60KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

471/11.11.2011

3.4

1951

CALCIUMVITAC

Effervescent

tablets x (500mg +

260mg)

ASCORBIC ACID +

CALCIUM (as CALCIUM

CARBONATE x 327mg and

CALCIUM

LACTOGLUCONATE x

1000mg)

Box x 1 plastic

container x 10

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

344/03.06.2010

1.47

1952

CIPRINOL

Concentrate for

solution for infusion

x 10mg/ml

CIPROFLOXACIN (AS

CIPROFLOXACIN LACTATE

x 12.8mg/ml)

Box x 5

ampoules x

10ml

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010

2.5

Page 262

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263

1953

CO-PRENESSATablets x (2mg +

0.625mg)

PERINDOPRIL ERBUMINE

(eq. to 1.669mg

PERINDOPRIL) +

INDAPAMIDE

Box x 30KRKA-POLSKA SP. Z.O.O.

- POLONI

KRKA-POLSKA SP. Z.O.O. -

POLONI

REGJ.

208/07.05.2012

4.5

1954

CO-PRENESSATablets x (8mg +

2.5mg)

PERINDOPRIL ERBUMINE

(eq. to 6.68mg

PERINDOPRIL) +

INDAPAMIDE

Box x 30"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENI; "KRKA POLSKA

SP. Z.O.O." POLONI; "TAD

PHARMA GMBH" GJERMANI

Regj.451/13.08.2013

5.51

1955

CO-PRENESSATablets x (4mg +

1.25mg)

PERINDOPRIL ERBUMINE

(eq. to 3.34mg

PERINDOPRIL) +

INDAPAMIDE

Box x 30"KRKA POLSKA SP.

Z.O.O." POLONI

"KRKA POLSKA SP. Z.O.O."

POLONIRegj.451/13.08.2013

3.31

1956DALERON Tablets x 500mg PARACETAMOL Box x 12

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.2010 0.49

1957

DALERONOral suspension x

120mg/5mlPARACETAMOL

Box x 1 flacon x

100ml

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.20102.2

1958

DALERON COLD3

Film-coated tablets

x (325mg + 30mg +

15mg)

PARACETAMOL x 325mg +

24.6mg

PSEUDOEPHEDRINE (AS

PSEUDOEPHEDRINE

HYDROCHLORIDE x 30mg)

+ 11mg

DEXTROMETHORPHAN

(AS

DEXTROMETHORPHAN x

15mg)

Box x 12,KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.2010

1.47

1959

DORETA

Film-coated tablets

x (37.5mg +

325mg)

TRAMADOL

HYDROCHLORIDE (eq. to

TRAMADOL x 32.94mg+

PARACETAMOL)

Box x 20"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENIRegj.451/13.08.2013

1.78

Page 263

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264

1960

DUOVIT

Red coated tablets

x (5000 IU + 200 IU

+ 60mg + 13mg +

10mg + 5mg + 2mg

+ 1.2mg + 1mg +

0.4mg + 3µg) Blue

coated tablets x

(20mg + 15mg +

12mg + 10mg +

3mg + 1mg + 1mg

+ 0.1mg)

Red coated tablets: VIT. A

(as RETINILPALMITAT) +

VIT. D3

(CHOLECALCIFEROL) +

VIT. C (ASCORBIC ACID) +

NICOTINAMIDE + VIT. E (α-

TOCOPHERYL ACETATE) +

CALCIUM PANTOTHENATE

+ VIT. B6 (PYRIDOXINE

HYDROCHLORIDE) + VIT.

B2 (RIBOFLAVINE) + VIT.

B1 (THIAMINE NITRATE) +

FOLIC ACID + VIT. B12

(CYANOCOBALAMINE).

Blue coated tablets:

MAGNESIUM (as

MAGNESIUM LACTATE) +

CALCIUM (as CALCIUM

HYDROGEN PHOSPHATE

DIHYDRATE) + PHOSPHOR

(as CALCIUM HYDROGEN

PHOSPHATE DIHYDRATE)

+ FERROUS (as FERROUS

FUMARATE) + ZINC (as

ZINC SULPHATE) +

COPPER (as COPPER

SULPHATE

PENTAHYDRATE) +

MANGANESE (as

MANGANESE SULPHATE

MONOHYDRATE) +

MOLYBDENUM (as SODIUM

MOLYBDATE DIHYDRATE)

Box x 40KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

167/19.04.2012

1.35

1961

ELICEAFilm coated tablets

x 10mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

x 12.78mg)

Box x 28"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENIRegj.451/13.08.2013

8

1962

EMANERA

Gastro-resistant

hard capsules x

20mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

20.645mg)

Box x 14,KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI; TAD PHARMA

GMBH - GJERMANI

REGJ.

213/09.05.2012

2.2

Page 264

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265

1963

EMANERA

Gastro-resistant

hard capsules x

40mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

41.29mg)

Box x 14KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI; TAD PHARMA

GMBH - GJERMANI

REGJ.

213/09.05.2012

3.6

1964

EMANERA

Gastro-resistant

hard capsules x

40mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

41.29mg)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI; TAD PHARMA

GMBH - GJERMANI

REGJ.

213/09.05.2012

6.5

1965

EMANERA

Gastro-resistant

hard capsules x

20mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

20.645mg)

Box x 28,KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI; TAD PHARMA

GMBH - GJERMANI

REGJ.

213/09.05.2012

4.1

1966ENAP Tablets x 5mg ENALAPRIL MALEATE Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

647/10.12.2010 1

1967ENAP Tablets x 10mg ENALAPRIL MALEATE Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

647/10.12.2010 1.2

1968

ENAP - HLTablets x (20mg +

12.5mg)

ENALAPRIL MALEATE +

HYDROCHLOROTHIAZIDEBox x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

470/31.08.2010

2.5

1969

ENAP-HTablets x (10mg +

25mg)

ENALAPRIL MALEATE +

HYDROCHLOROTHIAZIDEBox x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

REGJ.

205/20.05.2011

2

1970

GLICLADAProlonged-release

tablets x 30mgGLICLAZIDE Box x 60

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, D.D. NOVO MESTO -

SLLOVENI (APL: KRKA, D.D.

NOVO MESTO - SLLOVENI)

REGJ.

433/29.07.2010

4

1971

HERBION

Cowslip syrup x

(1.03g + 2.06g +

0.62mg) / 5ml

AQUEOUS EXTRACT OF

COWSLIP ROOTS (1:3.3) +

AQUEOUS EXTRACT OF

GARDEN THYME (1:3.3) +

LEVOMENTHOL

Box x 1glass

bottle x 150ml +

1teaspoon

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

REGJ.

733/28.12.2009

2.2

Page 265

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266

1972

HERBION

Plantain syrup x

(2.5g + 65mg)/5ml

(1 measuring

spoonful)

LIQUID EXTRACT OF THE

MIXTURE OF RIBWORT

PLANTAIN LEAVES

(PLANTAGO LANCEOLATA

L. S.L.,FOLIUM) AND

COMMON MALLOW

FLOWERS (MALVA

SYLVESTRIS L., FLOS),

WHICH IS EQUIVALENT TO

0.25G OF RIBWORT

PLANTAIN LEAVES AND

0.25G OF COMMON

MALLOW FLOWERS +

ASCORBIC ACID (AS

73.12MG SODIUM

ASCORBATE)

Box x 1 glass

bottle x 150ml +

1 teaspoon

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

REGJ.

290/06.05.2010

2.2

1973

IFIRMACOMBI

Film-coated tablets

x (150mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENI; "TAD PHARMA

GMBH" GJERMANI;

"RAFARM S.A.: GREQI

Regj.451/13.08.2013

5.76

1974

IFIRMACOMBI

Film-coated tablets

x (300mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENI; "TAD PHARMA

GMBH" GJERMANI;

"RAFARM S.A.: GREQI

Regj.451/13.08.2013

7.76

1975

IFIRMACOMBIFilm-coated tablets

x (300mg + 25mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENI; "TAD PHARMA

GMBH" GJERMANI;

"RAFARM S.A.: GREQI

Regj.451/13.08.2013

7.76

1976

KVENTIAXFilm coated tablets

x 25mg

QUETIAPINE (as

QUETIAPINE

HEMIFUMARATE)

Box x 60KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; KRKA POLSKA

SP. Z.O.O - POLONI (APL:

KRKA, DD, NOVO MESTO -

SLLOVENI)

REGJ.

249/21.04.2010

15

Page 266

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267

1977

KVENTIAXFilm coated tablets

x 100mg

QUETIAPINE (as

QUETIAPINE

HEMIFUMARATE)

Box x 60KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; KRKA POLSKA

SP. Z.O.O - POLONI (APL:

KRKA, DD, NOVO MESTO -

SLLOVENI)

REGJ.

249/21.04.2010

35

1978

KVENTIAXFilm coated tablets

x 150mg

QUETIAPINE (as

QUETIAPINE

HEMIFUMARATE)

Box x 60KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; KRKA POLSKA

SP. Z.O.O - POLONI (APL:

KRKA, DD, NOVO MESTO -

SLLOVENI)

REGJ.

249/21.04.2010

40

1979

KVENTIAXFilm coated tablets

x 200mg

QUETIAPINE (as

QUETIAPINE

HEMIFUMARATE)

Box x 60KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; KRKA POLSKA

SP. Z.O.O - POLONI (APL:

KRKA, DD, NOVO MESTO -

SLLOVENI)

REGJ.

249/21.04.2010

45

1980

KVENTIAXFilm coated tablets

x 300mg

QUETIAPINE (as

QUETIAPINE

HEMIFUMARATE)

Box x 60KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; KRKA POLSKA

SP. Z.O.O - POLONI (APL:

KRKA, DD, NOVO MESTO -

SLLOVENI)

REGJ.

249/21.04.2010

60

1981

LANZUL S Capsules x 15 mg LANSOPRAZOLE Box x 28

KRKA, TOVARNA

ZDRAVIL, D.D -

SLLOVENI

KRKA, TOVARNA ZDRAVIL,

D.D - SLLOVENI

REGJ.

619/05.11.20081.99

1982

LANZUL Capsules x 30 mg LANSOPRAZOLE Box x 28

KRKA, TOVARNA

ZDRAVIL, D.D -

SLLOVENI

KRKA, TOVARNA ZDRAVIL,

D.D - SLLOVENI

REGJ.

619/05.11.20082.19

1983LORISTA

Film coated tablets

x 100mgLOSARTAN POTASSIUM Box x 28

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

REGJ.

433/29.07.2010 3.17

1984

LORISTA HFilm-coated tablets

x (50mg + 12.5mg)

LOSARTAN POTASSIUM +

HYDROCHLOROTHIAZIDEBox x 28

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

235/07.06.2011

2.91

Page 267

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268

1985

LORISTA HDFilm-coated tablets

x (100mg + 25mg)

LOSARTAN POTASSIUM

(eq. to 91.52mg LOSARTAN)

+

HYDROCHLOROTHIAZIDE

Box x 28KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

235/07.06.2011

3.48

1986MACROPEN

Film-coated tablets

x 400mg MIDECAMYCIN Box x 16

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

583/29.10.2010 1.63

1987MIRZATEN

Film-coated tablets

x 30mgMIRTAZAPINE Box x 30

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

105/06.03.2012 5.29

1988MIRZATEN

Film-coated tablets

x 45mgMIRTAZAPINE Box x 30

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

105/06.03.2012 8.65

1989

MODITEN Coated tablets x

1mg

FLUPHENAZINE

HYDROCHLORIDE

Box x 1 glass

bottle x 25

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

645/10.12.20101.33

1990

MODITEN Coated tablets x

5mg

FLUPHENAZINE

HYDROCHLORIDE

Box x 1 glass

bottle x 100

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

645/10.12.201012.3

1991

NAKLOFEN

Solution for

injection x

75mg/3ml

DICLOFENAC SODIUMBox x 5

ampoules x 3ml

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.20101.23

1992

NAKLOFEN SRProlonged-release

tablets x 100mgDICLOFENAC SODIUM Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

35/25.01.20111.64

1993NAKLOFEN

Suppositories x

50mgDICLOFENAC SODIUM Box x 10

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010 0.41

1994

NALGESIN SFilm-coated tablets

x 275mg

NAPROXEN SODIUM (eq. to

251mg NAPROXEN)Box x 10

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

208/07.05.20121.51

1995NOLICIN

Film-coated tablets

x 400mgNORFLOXACIN Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010 2.2

1996

NOLPAZAGastro-resistant

tablets x 20mg

PANTOPRAZOLE x 20MG

(AS PANTOPRAZOLE

SODIUM SESQUIHYDRATE)

Box x 28KRKA TOVARNA

ZDRAVIL DD - SLLOVENI

KRKA D.D - SLLOVENI, (APL :

KRKA D.D - SLLOVENI)

REGJ.

285/11.05.2009

3

1997

NOLPAZAGastro-resistant

tablets x 40mg

PANTOPRAZOLE x 40MG

(AS PANTOPRAZOLE

SODIUM SESQUIHYDRATE)

Box x 28KRKA TOVARNA

ZDRAVIL DD - SLLOVENI

KRKA D.D - SLLOVENI, (APL :

KRKA D.D - SLLOVENI)

REGJ.

285/11.05.2009

5.8

Page 268

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269

1998NOVOLAX

Coated tablets x

5mgBISACODYL Box x 30

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010 1.39

1999

PIKOVIT

Coated tablets x

(600 IU + 80 IU +

10mg + 0.25mg +

0.3mg + 0.3mg +

0.2µg + 3mg +

1.2mg + 0.04mg +

12.5mg + 10mg)

VIT. A (as RETINYL

PALMITATE) + VIT. D3

(CHOLECALCIFEROL) +

VIT. C (ASCORBIC ACID) +

VIT. B1 (THIAMINE

NITRATE) + VIT. B2

(RIBOFLAVIN) + VITAMIN

B6 (PYRIDOXINE

HYDROCHLORIDE) + VIT.

B12 (CYANOCOBALAMIN) +

NICOTINAMIDE + CALCIUM

PANTHOTENATE + FOLIC

ACID + CALCIUM (as

CALCIUM HYDROGEN

PHOSPHATE) +

PHOSPHORUS (as

CALCIUM HYDROGEN

PHOSPHATE)

Box x 30KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

471/11.11.2011

2.2

Page 269

Page 270: Lista Me Cmimet e Barnave Jo Te Rimbursueshme 2014 , 17Feb2014

270

2000

PIKOVIT

Syrup x (900 IU +

100 IU + 50mg +

1mg + 1mg +

0.6mg + 1µg +

5mg + 2mg)/5ml

VIT. A (as RETINYL

PALMITATE) + VIT. D3

(CHOLECALCIFEROL) +

VIT. C (ASCORBIC ACID) +

VIT. B1 (THIAMINE

HYDROCHLORIDE) + VIT.

B2 (SODIUM RIBOFLAVIN

PHOSPHATE) + VITAMIN B6

(PYRIDOXINE

HYDROCHLORIDE) + VIT.

B12 (CYANOCOBALAMIN) +

NICOTINAMIDE +

DEXPANTHENOL

Box x 1 flacon x

150ml

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

48/30.01.2012

2.31

2001

PRENESSA Tablets x 4mg

PERINDOPRIL ERBUMINE

(eq. to 3.338mg

PERINDOPRIL)

Box x 30KRKA-POLSKA SP. Z.O.O.

- POLONI

KRKA-POLSKA SP. Z.O.O. -

POLONI

REGJ.

186/26.04.20122.66

2002

PRENESSA Tablets x 8mg

PERINDOPRIL ERBUMINE

(eq. to 6.676mg

PERINDOPRIL)

Box x 30KRKA-POLSKA SP. Z.O.O.

- POLONI

KRKA-POLSKA SP. Z.O.O. -

POLONI

REGJ.

186/26.04.20124.41

2003

RAWEL SR

Prolonged-release

film-coated tablets

x 1.5mg

INDAPAMIDE Box x 30KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

47/30.01.2012

2

2004

ROSWERAFilm-coated tablets

x 5mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 5.21mg)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

207/07.05.20122.2

2005

ROSWERAFilm-coated tablets

x 10mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 10.42mg)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

207/07.05.20124.5

2006

ROSWERAFilm-coated tablets

x 20mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 20.83mg)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

207/07.05.20126

2007

ROSWERAFilm-coated tablets

x 40mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 41.66mg)

Box x 28KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

207/07.05.20128.58

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271

2008

ROSWERAFilm-coated tablets

x 15mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 15.62mg)

Box x 28"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENIRegj.451/13.08.2013

5

2009

ROSWERAFilm-coated tablets

x 30mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 31.25mg)

Box x 28"KRKA D.D, NOVO

MESTO" SLLOVENI

"KRKA D.D, NOVO MESTO"

SLLOVENIRegj.451/13.08.2013

8

2010RUTACID

Chewable tablets x

500mgHYDROTALCITE Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010 1.22

2011

SEPTOLETE

CHERRYLozenges x 1.2mg

CETYLPYRIDINUM

CHLORIDEBox x 18

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

506/06.12.2011 1.76

2012

SEPTOLETE

APPLELozenges x 1.2mg

CETYLPYRIDINUM

CHLORIDEBox x 18

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

506/06.12.2011 1.76

2013

SEPTOLETE

LEMONLozenges x 1.2mg

CETYLPYRIDINUM

CHLORIDEBox x 18

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

506/06.12.2011 1.76

2014

SEPTOLETE

MENTHOLLozenges x 1mg

BENZALKONIUM

CHLORIDEBox x 30

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

297/25.06.2012 1.76

2015

SEPTOLETE

PLUS HONEY

AND LIME

Lozenges x (5mg +

1mg)

BENZOCAINE +

CETYLPIRIDINIUM

CHLORIDE

Box x 18KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

REGJ.

205/20.05.20112.2

2016

SEPTOLETE

PLUS

Oromucosal spray,

solution x (2mg +

10mg)/ml

CETYLPYRIDINUM

CHLORIDE + BENZOCAINE

Box x 1 plastic

container x 30ml

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

REGJ.

297/25.06.2012

2.44

2017

STUGERON

FORTETablets x 75mg CINNARIZINE Box x 50

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

409/07.10.2011 1.35

2018TORENDO

Film-coated tablets

x 1mgRISPERIDONE Box x 20

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

190/27.04.2012 0.88

2019

TEOTARD

Hard prolonged-

release capsules x

350mg

THEOPHYLLINE Box x 40KRKA D.D., NOVO

MESTO - SLLOVENI

KRKA D.D., NOVO MESTO -

SLLOVENI

RIREGJ.

366/23.09.2011

2.52

2020TORENDO

Film-coated tablets

x 3mgRISPERIDONE Box x 20

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

190/27.04.2012 2.16

2021TORENDO

Film-coated tablets

x 4mgRISPERIDONE Box x 20

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

190/27.04.2012 2.89

2022TORENDO Q-TAB

Orodispersible

tablets x 0.5mgRISPERIDONE Box x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

266/12.06.2012 1.83

2023TORENDO Q-TAB

Orodispersible

tablets x 1mgRISPERIDONE Box x 28

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI

RIREGJ.

266/12.06.2012 2.2

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272

2024TRAMADOL

Hard capsules x

50mg

TRAMADOL

HYDROCHLORIDEBox x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.2010 2.1

2025

TRAMADOLOral drops, solution

x 100mg/ml

TRAMADOL

HYDROCHLORIDE

Box x 1 glass

bottle x 10ml

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.20102.44

2026TRAMADOL

Suppositories x

100mg

TRAMADOL

HYDROCHLORIDEBox x 5

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.2010 0.92

2027

TRAMADOL

Solution for

injection or infusion

x 50mg/ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 1ml

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

602/05.11.2010

1.99

2028

TRAMADOL

Solution for

injection or infusion

x 100mg/2ml

TRAMADOL

HYDROCHLORIDE

Box x 5

ampoules x 2ml

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI

RIREGJ.

676/31.12.2010

2.64

2029

VIZARSINFilm-coated tablets

x 25mgSILDENAFIL (as CITRATE) Box x 4

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI, TAD PHARMA

GMBH - GJERMANI,

RAFARM SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

345/26.07.2012

5

2030

VIZARSINFilm-coated tablets

x 50mgSILDENAFIL (as CITRATE) Box x 1,

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI, TAD PHARMA

GMBH - GJERMANI,

RAFARM SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

345/26.07.2012

2.4

2031

VIZARSINFilm-coated tablets

x 100mgSILDENAFIL (as CITRATE) Box x 1,

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI, TAD PHARMA

GMBH - GJERMANI,

RAFARM SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

345/26.07.2012

3

2032

VIZARSINFilm-coated tablets

x 50mgSILDENAFIL (as CITRATE) Box x 4

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI, TAD PHARMA

GMBH - GJERMANI,

RAFARM SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

345/26.07.2012

7.84

Page 272

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273

2033

VIZARSINFilm-coated tablets

x 100mgSILDENAFIL (as CITRATE) Box x 4

KRKA D.D, NOVO MESTO

- SLLOVENI

KRKA D.D, NOVO MESTO -

SLLOVENI, TAD PHARMA

GMBH - GJERMANI,

RAFARM SA

PHARMACEUTICAL

INDUSTRY - GREQI

REGJ.

345/26.07.2012

9.8

2034

ZOLSANAFilm coated tablets

x 5mgZOLPIDEM TARTRATE Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; SYNTHON

HISPANIA SL - SPANJE;

SYNTHON BV - HOLLANDE

REGJ.

570/27.10.2009

2.2

2035

ZOLSANAFilm coated tablets

x 10mgZOLPIDEM TARTRATE Box x 20

KRKA, DD, NOVO MESTO

- SLLOVENI

KRKA, DD, NOVO MESTO -

SLLOVENI; SYNTHON

HISPANIA SL - SPANJE;

SYNTHON BV - HOLLANDE

REGJ.

570/27.10.2009

3

2036

DIANE-35Coated tablets x

(2mg + 0.035mg)

CYPROTERONE ACETATE

+ ETHINYLESTRADIOLBox x 21

BAYER VITAL GMBH -

GJERMANI

SCHERING GMBH & CO.

PRODUKTIONS KG -

GJERMANI; BAYER

SCHERING PHARMA AG -

GJERMANI; DELPHARM

LILLE SAS - FRANCE (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

366/23.09.2011

5.31

2037

FEMODEN

Coated tablets x

(0.075mg +

0.03mg)

GESTODENE +

ETHINYLESTRADIOLBox x 21

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI, SHERING

GMBH & CO. PRODUKTIONS

KG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

597/26.11.2012

5.5

2038

GADOVIST PFS

Solution for

injection x

1.0mmol/ml

GADOBUTROL (eq. to

604.720mg/ml

GADOBUTROL)

Box x 5 pre-

filled syringes x

7.5ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

168/04.05.2011

273

Page 273

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274

2039

GASTROGRAFIN

Oral and rectal

solution x (66g +

10g)/100ml

AMIDOTRIZOIC ACID,

MEGLUMINE SALT +

SODIUM AMIDOTRIZOATE

(corresp. to 37g bound

IODINE)

Box x 1 flacon x

100ml

BAYER VITAL GMBH -

GJERMANI

BERLIMED SA - SPANJE

(APL: BAYER SCHERING

PHARMA AG - GJERMANI)

RIREGJ.

260/12.06.2012

9

2040

UROGRAFIN 76%

Solution for

injection and

infusion x (0.1g +

0.66g)/1ml

SODIUM AMIDOTRIZOATE

(eq. to AMIDOTRIZOIC ACID

x 597.3mg/ml) +

MEGLUMINE

AMIDOTRIZOATE (eq. to

MEGLUMINE x

159.24mg/ml)

Box x 10

ampoules x

20ml

QUIMICA

FARMACEUTICA BAYER

SL - SPANJE

BERLIMED SA - SPANJE RIREGJ.

332/29.08.2011

18.26

2041

MAGNEVIST

Aqueous solution

for injection x

469.01mg/1ml

(0.5mmol/ml)

GADOPENTETIC ACID,

DIMEGLUMINE SALT

(corresp. to 78.63mg/ml

GADOLINIUM)

Box x 10 glass

vials x 10ml (for

hospital use

only)

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

260/12.06.2012

353

2042

MAGNEVIST

Aqueous solution

for injection x

469.01mg/1ml

(0.5mmol/ml)

GADOPENTETIC ACID,

DIMEGLUMINE SALT

(corresp. to 78.63mg/ml

GADOLINIUM)

Box x 1 glass

vial x 20ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

260/12.06.2012

46

2043

MICROGYNONCoated tablets x

(0.15mg + 0.03mg)

LEVONORGESTREL +

ETHINYLESTRADIOL

Box x 1 blister x

21 coated

tablets;

BAYER VITAL GMBH -

GJERMANI

SCHERING GMBH & CO.

PRODUKTIONS KG -

GJERMANI; BAYER

SCHERING PHARMA AG -

GJERMANI (APL: BAYER

SCHERING PHARMA AG -

GJERMANI)

RIREGJ.

282/07.07.2011

3.5

2044

NEBIDO

Solution for

injection x

1000mg/4ml

TESTOSTERONE

UNDECANOATE (eq. to

157.9mg/ml

TESTOSTERONE)

Box x 1

ampoule x 4ml

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI

RIREGJ.

105/06.03.2012

88.43

2045

NEO - PENOTRANPessaries x

(500mg + 100mg)

METRONIDAZOLE +

MICONAZOLE NITRATEBox x 14

EMBIL ILAC SAN. LTD -

TURQI

EMBIL ILAC SAN. LTD -

TURQI

RIREGJ.

161/19.03.20106.2

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275

2046

NEO-PENOTRAN

FORTE

Pessaries x (750

mg + 200 mg)

METRONIDAZOLE +

MICONAZOLE NITRATEBox x 7

"EMBIL ILAC SAN. LTD"

TURQI

"EMBIL ILAC SAN. LTD"

TURQIRiregj.468/03.09.201

3 6.5

2047

PRIMOLUT-NOR-5 Tablets x 5mgNORETHISTERONE

ACETATE

Box x 2 blisters

x 10

BAYER VITAL GMBH -

GJERMANI

SCHERING GMBH UND CO.

PRODUKTIONS KG -

GJERMANI (APLIKANT:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

392/01.07.2009

3.76

2048

ULTRAVIST-300Aqueous solution x

623.40mg/ml IOPROMIDE

Box x 10 glass

bottles x 50ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

299/25.06.2012

165

2049

ULTRAVIST-300Aqueous solution x

623.40mg/ml IOPROMIDE

Box x 10 glass

bottles x 100ml

(for hospital use

only)

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

299/25.06.2012

290

2050

ULTRAVIST-370Aqueous solution x

768.86mg/mlIOPROMIDE

Box x 1 glass

bottle x 50ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

713/21.12.2009

27

2051

ULTRAVIST-370Aqueous solution x

768.86mg/mlIOPROMIDE

Box x 8 glass

bottle x 500ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

713/21.12.2009

2700

2052

ULTRAVIST-370Aqueous solution x

768.86mg/mlIOPROMIDE

Box x 10 glass

bottle x 100ml,

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

713/21.12.2009

330

2053

ULTRAVIST-370Aqueous solution x

768.86mg/mlIOPROMIDE

Box x 10 glass

bottle x 200ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

713/21.12.2009

600

Page 275

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276

2054

YASMIN

Film - coated

tablets x (3mg +

0.03mg)

DROSPIRENONE +

ETHINYLESTRADIOLBox x 21

BAYER VITAL GMBH -

GJERMANI

SCHERING GMBH & CO

PRODUCTION KG -

GJERMANI; BAYER

SCHERING PHARMA AG -

GJERMANI (APLIKANT PER

CERTIFIKATE: BAYER

SCHERING AG - GJERMANI)

RIREGJ.

266/19.04.2013

7

2055

AVELOXFilm coated tablets

x 400mg

MOXIFLOXACIN (as

MOXIFLOXACIN

HYDROCHLORIDE x

436.8mg)

Box x 5BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI,

STEGEMANN

LOHNVERPACKUNG &

LOGISTISCHER SERVICE

E.K. - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

71/09.02.2010;

VARIACION EMRI

TREGTAR

15.7

2056

AVELOX

Solution for

infusion x

400mg/250ml

MOXIFLOXACIN (as

MOXIFLOXACIN

HYDROCHLORIDE x

436.8mg/250ml)

Box x 1 glass

bottle x 250ml

BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI,

STEGEMANN

LOHNVERPACKUNG &

LOGISTISCHER SERVICE

E.K. - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

71/09.02.2010;

VARIACION EMRI

TREGTAR

39.59

2057

ILOMEDIN

Concentrate for

solution for infusion

20μg/1ml

ILOPROST (as ILOPROST-

TROMETAMOL x

0.027mg/1ml)

Box x 5

ampoules x 1ml

BAYER VITAL GMBH -

GJERMANI

BERLIMED, S.A. - SPANJË;

BAYER SCHERING PHARMA

AG - GJERMANI (APLIKANT

PËR CERTIFIKATË: BAYER

SCHERING PHARMA AG -

GJERMANI)

RIREGJ.

300/12.05.2010

180.5

Page 276

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277

2058

ASPIRIN

PROTECT

Enteric coated

tablets x 100mgACETYLSALICYLIC ACID Box x 30

BAYER VITAL GMBH -

GJERMANI

BAYER BITTERFELD GMBH -

GJERMANI (APL: BAYER

CONSUMER CARE AG -

ZVICER)

RIREGJ.

632/19.11.2009

1.34

2059

ASPIRIN

PROTECT

Enteric coated

tablets x 100mgACETYLSALICYLIC ACID Box x 40

BAYER VITAL GMBH -

GJERMANI

BAYER BITTERFELD GMBH -

GJERMANI (APL: BAYER

CONSUMER CARE AG -

ZVICER)

RIREGJ.

632/19.11.2009

1.55

2060

ASPIRIN PLUS C

Effervescent

tablets x (400mg +

240mg)

ACETYLSALICYLIC ACID +

VITAMIN C Box x 10

BAYER D.O.O -

SLLOVENI

BAYER BITTERFELD GMBH -

GJERMANI (APL: BAYER

CONSUMER CARE AG -

ZVICER)

RIREGJ.

632/19.11.2009

2.66

2061

ASPIRIN Tablets x 500mg ACETYLSALICYLIC ACID Box x 20BAYER D.O.O -

SLLOVENI

BAYER BITTERFELD GMBH -

GJERMANI (APL: BAYER

CONSUMER CARE AG -

ZVICER)

RIREGJ.

632/19.11.2009

1.3

2062

CANESTEN Cream x 1% CLOTRIMAZOLEBox x 1 tube x

20g

BAYER D.O.O -

SLLOVENI

KERN PHARMA - SPANJE

(APL: BAYER CONSUMER

CARE AG - ZVICER)

RIREGJ.

672/08.12.2009

2.6

2063

CANESTEN DROP

SOLUTION

Drop solution x

1g/100mlCLOTRIMAZOLE

Box x bottle x

20ml

BAYER D.O.O -

SLLOVENI

KVP PHARMA + VETERINAR

PRODUKTE GMBH -

GJERMANI (APLIKANT:

BAYER CONSUMER CARE

AG - ZVICËR)

RIREGJ.

734/28.12.2009

2.6

2064

CANESTEN GYN 3-

DAY-THERAPY

Vaginal tablets x

200mgCLOTRIMAZOLE Box x 3

BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER CONSUMER CARE

AG - ZVICER)

RIREGJ.

78/11.02.2010

4.5

2065

CANESTEN GYN 3-

DAY-THERAPY

VAGINAL CREAM

Cream x 2% CLOTRIMAZOLE

Box x 1 tube x

20g + 3

applicators

BAYER D.O.O -

SLLOVENI

KERN PHARMA - SPANJE

(APL: BAYER CONSUMER

CARE AG - ZVICER)

RIREGJ.

672/08.12.2009

4.5

Page 277

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278

2066

RUPURUTChewable tablets x

500mgHYDROTALCITE Box x 20

BAYER D.O.O -

SLLOVENI

BAYER BITTERFELD GMBH -

GJERMANI (APL: BAYER

CONSUMER CARE AG -

ZVICER)

RIREGJ.

78/11.02.2010

1.7

2067

GLUCOBAY 50MG Tablets x 50mg ACARBOSE Box x 21 BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

632/19.11.2009;

VARIACION MAH

687/1/09.10.20134.5

2068

GLUCOBAY

100MGTablets x 100mg ACARBOSE Box x 21

BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

632/19.11.2009;

VARIACION MAH

687/1/09.10.20136.5

2069

KOGENATE

BAYER

Powder and

solvent for solution

for injection x 250

I.U./vial

RECOMBINANT

COAGULATION FACTOR

VIII (OCTOCOG ALFA)

Box x (1 Vial + 1

Pre-filled

syringe + 1 Bio-

Set device)

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER HEALTHCARE LLC -

SHBA, BAYER HEALTHCARE

MANUFACTURING SRL -

ITALI, BAYER SCHERING

PHARMA AG - GJERMANI

REGJ. 41/28.01.2009

160

2070

KOGENATE

BAYER

Powder and

solvent for solution

for injection x 500

I.U./vial

RECOMBINANT

COAGULATION FACTOR

VIII (OCTOCOG ALFA)

Box x (1 Vial + 1

Pre-filled

syringe + 1 Bio-

Set device)

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER HEALTHCARE LLC -

SHBA, BAYER HEALTHCARE

MANUFACTURING SRL -

ITALI, BAYER SCHERING

PHARMA AG - GJERMANI

REGJ. 41/28.01.2009

312

2071

KOGENATE

BAYER

Powder and

solvent for solution

for injection x 1000

I.U./vial

RECOMBINANT

COAGULATION FACTOR

VIII (OCTOCOG ALFA)

Box x (1 Vial + 1

Pre-filled

syringe + 1 Bio-

Set device)

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER HEALTHCARE LLC -

SHBA, BAYER HEALTHCARE

MANUFACTURING SRL -

ITALI, BAYER SCHERING

PHARMA AG - GJERMANI

REGJ. 41/28.01.2009

620

Page 278

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279

2072

NEXAVARFilm Coated

Tablets x 200 mg

SORAFENIB (as

SORAFENIB TOSYLATE)Box x 112

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER SCHERING PHARMA -

GJERMANI; BAYER

HEALTHCARE

MANUFACTURING SRL -

ITALI

REGJ.

569/24.10.2008

3562

2073

XARELTOFilm coated tablets

x 10mg

RIVAROXABAN

MICRONIZEDBox x 10;

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER SCHERING PHARMA -

GJERMANI; STEGEMANN -

GJERMANI; BAYER

HEALTHCARE

MANUFACTURING SRL -

ITALI

REGJ.

192/19.03.2009

25

2074

XARELTOFilm coated tablets

x 10mg

RIVAROXABAN

MICRONIZED Box x 30

BAYER SCHERING

PHARMA AG - GJERMANI

BAYER SCHERING PHARMA -

GJERMANI; STEGEMANN -

GJERMANI; BAYER

HEALTHCARE

MANUFACTURING SRL -

ITALI

REGJ.

192/19.03.2009

75

2075

MIRENA

Intrauterine

delivery system

(intrauterine device

with hormone

release) x

52mg/1delivery

system (20mcg/24

hours)

LEVONORGESTREL

Box x 1 sterile

intrauterine

delivery system

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

OY - FINLANDE (APL: BAYER

SCHERING PHARMA AG -

GJERMANI)

RIREGJ.

470/31.08.2010

105

2076

GADOVIST PFS

Solution for

injection x

1.0mmol/ml

GADOBUTROL (eq. to

604.720mg/ml

GADOBUTROL)

Box x 5 pre-

filled syringes x

15ml

BAYER VITAL GMBH -

GJERMANI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

168/04.05.2011

490

Page 279

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280

2077

QLAIRA

Dark yellow film-

coated tablets x

3mg; Medium red

film-coated tablets

x (2mg + 2mg);

Light yellow film-

coated tablets x

(2mg + 3mg); Dark

red film-coated

tablets x 1mg;

White film-coated

tablets x none

ESTRADIOL VALERATE;

(ESTRADIOL VALERATE +

DIENOGEST); (ESTRADIOL

VALERATE + DIENOGEST);

ESTRADIOL VALERATE;

NONE

Box x 28 film-

coated tablets

(2 dark yellow +

5 medium red +

17 light yellow +

2 dark red + 2

white)

BAYER VITAL GMBH -

GJERMANI

SCHERING GMBH & CO.

PRODUKTIONS KG -

GJERMANI (APL: BAYER

SCHERING PHARMA AG -

GJERMANI)

REGJ.

527/01.10.2010

8.25

2078

BONEFOSFilm-coated tablets

x 800mg

DISODIUM CLODRONATE

ANHYDRATE (as DISODIUM

CLODRONATE

TETRAHYDRATE x 1000mg)

Box x 60BAYER VITAL GMBH -

GJERMANI

BAYER OY - FINLANDE (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

458/16.08.2010

149.28

2079

XARELTOFilm-coated tablets

x 15mgRIVAROXABAN Box x 28

BAYER PHARMA AG -

GJERMANI

BAYER PHARMA AG -

GJERMANI; STEGEMANN

LOHNVERPACKUNG &

LOGISTISCHER SERVICE

E.K. - GJERMANI

REGJ.

298/25.06.2012

56.56

2080

XARELTOFilm-coated tablets

x 15mgRIVAROXABAN Box x 14

BAYER PHARMA AG -

GJERMANI

BAYER PHARMA AG -

GJERMANI; STEGEMANN

LOHNVERPACKUNG &

LOGISTISCHER SERVICE

E.K. - GJERMANI

REGJ.

298/25.06.2012

35

Page 280

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281

2081

XARELTOFilm-coated tablets

x 20mgRIVAROXABAN , Box x 28

BAYER PHARMA AG -

GJERMANI

BAYER PHARMA AG -

GJERMANI; STEGEMANN

LOHNVERPACKUNG &

LOGISTISCHER SERVICE

E.K. - GJERMANI

REGJ.

298/25.06.2012

56.56

2082

XARELTOFilm-coated tablets

x 20mgRIVAROXABAN Box x 14

BAYER PHARMA AG -

GJERMANI

BAYER PHARMA AG -

GJERMANI; STEGEMANN

LOHNVERPACKUNG &

LOGISTISCHER SERVICE

E.K. - GJERMANI

REGJ.

298/25.06.2012

35

2083

TRAVOGEN Cream x 1% ISOCONAZOLE NITRATEBox x tube x

20gINTENDIS SPA - ITALI

INTENDIS MANUFACTURING

SPA - ITALI

RIREGJ.

672/08.12.20092.78

2084

TRAVOCORTCream x (0.1% +

1%)

DIFLUCORTOLONE

VALERATE x 0.1g/100g +

ISOCONAZOLE NITRATE x

1g/100g

Box x 1 tube x

20gINTENDIS SPA - ITALI

INTENDIS MANUFACTURING

SPA - ITALI

RIREGJ.

470/31.08.2010

4.5

2085

DOLOPROCT

Suppositories x (1

mg + 40 mg)/1

suppository

FLUOCORTOLONE

PIVALATE + LIDOCAINE

HYDROCHLORIDE

MONOHYDRATE

Box x 10INTENDIS GMBH AG -

GJERMANI

ISTITUTO DE ANGELI SRL -

ITALI (APLIKANT: INTENDIS

GMBH - GJERMANI)

REGJ. 41/28.01.2009

7.2

2086

DOLOPROCTCream x (1 mg +

20 mg)/1 g

FLUOCORTOLONE-21-

PIVALATE + LIDOCAINE

HYDROCHLORIDE

MONOHYDRATE

Box x 1 Tube x

15 g

INTENDIS GMBH AG -

GJERMANI

INTENDIS MANUFACTURING

SPA - ITALI (APLIKANT:

INTENDIS GMBH -

GJERMANI)

REGJ. 41/28.01.2009

4.54

2087

YAZ Film Coated tablets

x (0.02mg + 3mg)

ETHINYLESTRADIOL (AS

BETADEX CLATHRATE) +

DROSPIRENONE

Box x 28 (24 +

4)BAYER BV - HOLLANDE

SCHERING GMBH UND CO.

PRODUKTIONS KG -

GJERMANI, BAYER

SCHERING PHARMA AG -

GJERMANI (APL: BAYER

SCHERING PHARMA AG -

GJERMANI)

REGJ.

222/08.04.2009

7.5

Page 281

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282

2088

EYLEASoluton for

injection x 40mg/mlAFLIBERCEPT

Box x 1 vial x

100 microliters

"BAYER PHARMA AG"

GJERMANI

"REGENERON

PHARMACEUTICALS, INC"

SHB A; "BAYER PHARMA

AG" GJERMANI; "VETTER

PHARMA" - FERTIGUNG

GMBH & CO.KG" GJERMANI

Regj.451/13.08.2013

838.88

2089

ABIZOL Tablets x 10mg ARIPIPRAZOLE Box x 28NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBEL ILAC SANAYII VE

TICARET AS - TURQIREGJ. 3/07.01.2013

30

2090

AKSEFFilm-coated tablets

x 500mg

CEFUROXIME (as

CEFUROXIME AXETIL x

601.44mg)

Box x 10 NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

46/30.01.201214.5

2091

AKSEF

Powder and

solvent for solution

for injection x

750mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM)

Box x 1 glass

vial + 1 ampoule

x 6ml solvent

(water for

injection)

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

PHARMAVISION SANAYII VE

TICARET AS - TURQI;

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

75/17.02.2012

2.2

2092

ALORASyrup x

694.444mg/5ml

FLUID EXTRACT OF

PASSIFLORA 0.4%.

[PASSIFLORA FLOWERS

FLUID EXTRACT

CONTAINS NOT LESS

THAN 0.4% OF TOTAL

FLAVONOIDS EXPRESSED

AS ANHYDROUS RUTIN

WITH A VEGETAL

PRODUCT - EXTRACT

RATIO (DER) OF 1.8-4.2 : 1]

Box x 1 glass

bottle x 100ml

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

506/06.12.2011

2

2093

ALORAFilm-coated tablets

x 100mg

PASSIFLORA DRY

EXTRACT (CONTAINS 3.5%

FLAVONOID AS VITEXIN)

Box x 20 NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

264/12.06.2012

2

Page 282

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283

2094

ALZANCERFilm-coated tablets

x 5mg

DONEPEZIL

HYDROCHLORIDE (eq. to

4.56mg DONEPEZIL)

Box x 14NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

264/12.06.201211

2095

ALZANCERFilm-coated tablets

x 10mg

DONEPEZIL

HYDROCHLORIDE (eq. to

9.12mg DONEPEZIL)

Box x 28NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

264/12.06.201226

2096

AMBREKS Syrup x 30mg/5mlAMBROXOL

HYDROCHLORIDE

Box x flacon x

150ml

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

REGJ.

183/18.03.20092.2

2097

AMBREKSPediatric syrup x

15mg/5ml

AMBROXOL

HYDROCHLORIDE

Box x flacon x

100ml

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

Riregj.

385/ 17.06.20131.77

2098

ANZIBEL

LOZENGE WITH

HONEY AND

LEMON FLAVOR

Lozenge x (5mg +

4mg + 3mg)

CHLORHEXIDINE HCL +

BENZOCAINE +

ENOXOLONE

Box x 30NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQIRegj.422/11.07.2013

1.1

2099

ANZIBEL

LOZENGE WITH

MENTHOL

FLAVOR

Lozenge x (5mg +

4mg + 3mg)

CHLORHEXIDINE HCL +

BENZOCAINE +

ENOXOLONE

Box x 30NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQIRegj.422/11.07.2013

1.1

2100

AZAXFilm coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524mg)

Box x 3 NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

380/13.08.20125.5

2101

CANTAB Tablet x 8mg CANDESARTAN CILEXETIL Box x 28NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI Regj.422/11.07.2013

10

2102

CO-IRDA

Film-coated tablets

x (150mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQIREGJ. 3/07.01.2013

8

2103

CO-IRDA

Film-coated tablets

x (300mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQIREGJ. 3/07.01.2013

11

2104

CLASTFilm-coated tablets

x 10mg

MONTELUKAST (as

MONTELUKAST SODIUM x

10.4mg)

Box x 28NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

264/12.06.201214

Page 283

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284

2105

ESRAM Film coated tablets

x 10mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

x 12.775mg)

Box x 28NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

Riregj.

476/09.09.20138.85

2106

ESRAM Film coated tablets

x 20mg

ESCITALOPRAM (as

ESCITALOPRAM OXALATE

x 25.55mg)

Box x 28NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

Riregj.

476/09.09.201314

2107

ETOL FORTFilm-coated tablets

x 400mg

ETODOLAC (eq. to 408mg

ETODOLAC DC 98%)Box x 14

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

46/30.01.20126.15

2108

FUNGOSTATIN

Powder for oral

suapension x

100000IU/ml

NYSTATIN ( x 1000mg/unit

dose)

Box x 1 vial x

60ml

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

307/07.05.20132

2109

FUNITMicropellet

capsules x 100mgITRACONAZOLE Box x 4

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

366/23.09.20114.4

2110

FUNITMicropellet

capsules x 100mgITRACONAZOLE Box x 15

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

366/23.09.201112

2111

HERNOVIR Cream x 5% ACYCLOVIRBox x 1 tube x

10g

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

168/04.05.20112

2112

KONVERIL Tablets x 10mg ENALAPRIL MALEATE Box x 20NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

190/12.05.20111.7

2113

KONVERIL PLUSTablets x (20mg +

12.5mg)

ENALAPRIL MALEATE +

HYDROCHLOROTHIAZIDEBox x 20

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

190/12.05.2011

2.5

2114

LEBEL Film coated tablets

x 500mg

LEVOFLOXACIN (as

LEVOFLOXACIN

HEMIHYDRATE x 512.46mg)

Box x 7NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

Riregj.

476/09.09.2013

16

2115

LEBEL Film coated tablets

x 750mg

LEVOFLOXACIN (as

LEVOFLOXACIN

HEMIHYDRATE x 768.69mg)

Box x 7NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

Riregj.

476/09.09.2013

20

2116

LORDES Syrup x 2.5mg/5ml DESLORATADINEBox x 1 bottle x

150ml

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

331/29.08.20114.4

Page 284

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285

2117

LORDESFilm coated tablets

x 5mgDESLORATADINE Box x 20

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

331/29.08.20114.4

2118

DEKSALGIN

Solution for

injection x

50mg/2ml

DEXKETOPROFEN (as

DEXKETOPROFEN

TROMETAMOL x

73.8mg/2ml)

Box x 6

ampoules s 2ml

NOBEL ILAC

PAZARLAMA VE SANAYII

LTD STI- TURQI

IDOL ILAC DOLUM SANAYII

VE TICARET AS - TURQIREGJ. 61/06.02.2013

5.5

2119

LIPOFEN SR

Sustained release

micropellet

capsules x 250mg

FENOFIBRATE Box x 30NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

REGJ.

327/26.05.2010

7

2120

MELBEK Tablets x 7.5mg MELOXICAM Box x 30NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

366/23.09.20115.5

2121

MELBEK FORT Tablets x 15mg MELOXICAM Box x 10 NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

366/23.09.20113

2122

MELBEK

Solution for

injection x

15mg/1.5ml

MELOXICAM

Box x 3

ampoules x

1.5ml

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

IDOL ILAC DOLUM SANAYII

VE TICARET AS - TURQI

RIREGJ.

46/30.01.20121.8

2123

MYCOCUR Topical spray x 1%TERBINAFINE

HYDROCHLORIDE

Box x flacon x

30ml

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

Riregj.423/11.07.201

35

2124

MEXIAFilm-coated tablets

x 20mg

MEMANTINE

HYDROCHLORIDEBox x 84

NOBEL ILAC

PAZARLAMA VE SANAYII

LTD STI- TURQI

NOBEL ILAC SANAYII VE

TICARET AS - TURQIREGJ. 3/07.01.2013

88

2125

MYCOCUR 1% Cream x 1%

TERBINAFINE

HYDROCHLORIDE (eq. to

8.888mg/g TEREBINAFINE)

Box x tube x

15g

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI Regj.422/11.07.2013

3

2126

PREFIXFilm-coated tablets

x 500mg

CEFPROZIL (as

CEFPROZIL

MONOHYDRATE x

523.13mg)

Box x 20 NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

420/13.10.2011

12

2127

PREFIX

Powder for oral

suspension x

250mg/5ml

CEFPROZIL (as

CEFPROZIL

MONOHYDRATE x

261.55mg/5ml)

Box x 1 bottle x

100ml

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

REGJ.

420/13.10.2011

8

Page 285

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286

2128

PULCETEnteric coated

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.10mg)

Box x 14NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

366/23.09.2011

8

2129

TYLOL HOT-D

Effervescent

powder for oral

suspension x

(500mg + 4mg +

60mg)/sachets

PARACETAMOL +

CHLORPHENIRAMINE

MALEATE +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 12

sachets x 6g

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

506/06.12.2011

2.7

2130

TYLOL HOT

Effervescent

granules for oral

suspension x

(500mg + 4mg +

60mg)/sachets

PARACETAMOL +

CHLORPHENIRAMINE

MALEATE +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 12

sachets x 20g

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

282/07.07.2011

2.62

2131

TYLOL

SUSPENSION

Suspension x

120mg/5mlPARACETAMOL

Box x 1 flacon x

100ml

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

265/12.06.20122.2

2132

TYLOL Tablet x 500mg

PARACETAMOL (as

PARACETAMOL DC 96 X

520.833MG )

Box x 20NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI Regj.422/11.07.2013

0.43

2133

TYLOL HOT

PEDIATRIC

Effervescent

powder for oral

suspension x

(250mg + 2mg +

30mg)/sachets

PARACETAMOL +

CHLORPHENIRAMINE

MALEATE +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 12

sachets x 10g

NOBEL ILAC SANAYII VE

TICARET AS - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET AS - TURQI

RIREGJ.

506/06.12.2011

1.8

2134

TYLOL COLD

Syrup x (160mg +

1mg + 5mg

+15mg)/5ml

PARACETAMOL +

CHLORPHENIRAMINE

MALEATE +

DEXTROMETHORPHAN

HYDROBROMIDE +

PSEUDOEPHEDRINE

HYDROCHLORIDE

Box x 1 flac x

100ml

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI Regj.422/11.07.2013

2

2135

ULTROXFilm coated tablets

x 10mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM)Box x 28

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

NOBELFARMA ILAC SANAYII

VE TICARET A.S. - TURQI

REGJ.

327/26.05.201011

2136

ZOLTEMSolution for

injection x 4mg/2ml

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE)

Box x 1

ampoule

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

MEFAR ILAC SANAYII AS -

TURQI

REGJ.

327/26.05.2010

3.5

Page 286

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287

2137

ZOLTEMSolution for

injection x 8mg/4ml

ONDANSETRON (as

ONDANSETRON

HYDROCHLORIDE

DIHYDRATE)

Box x 1

ampoule

NOBEL ILAC SANAYII VE

TICARET A.S. - TURQI

MEFAR ILAC SANAYII AS -

TURQI

REGJ.

327/26.05.2010

4.47

2138

AZYCYNAFilm-coated tablets

x 500mgAZITHROMYCIN Box x 3

"PABIANICKIE ZAKLADY

FARMACEUTYCZNE

POLFA SA" POLONI

"PABIANICKIE ZAKLADY

FARMACEUTYCZNE POLFA

SA" POLONI

Regj.451/13.08.2013

4.2

2139

AMOXICILLIN

SODIUM

Powder for solution

for

injection/infusion x

500mg/vial

AMOXICILLIN

Box x 10 vials

(for hospital

use)

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR,

LABESFAL-LABORATORIOS

ALMIRO SA - PORTUGALI,

ISTITUTO BIOCHIMICO

ITALIANO GIOVANNI

LORENZINI SPA - ITALI, CP

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR

REGJ.

264/12.06.2012

14

2140

AMOXICILLIN

SODIUM

Powder for solution

for injection x

1g/vial

AMOXICILLIN Box x 1 vial

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR,

LABESFAL-LABORATORIOS

ALMIRO SA - PORTUGALI,

ISTITUTO BIOCHIMICO

ITALIANO GIOVANNI

LORENZINI SPA - ITALI, CP

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR

REGJ.

264/12.06.2012

2.6

Page 287

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288

2141

CO-CODAMOL Tablets x (30mg +

500mg)

CODEINE PHOSPHATE +

PARACETAMOLBox x 30

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR;

WOCKHARDT LIMITED -

INDI; NESTOR (UK) LIMITED -

MBRETERI E BASHKUAR; CP

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR

REGJ.

449/28.10.2011

3.5

2142

FLUCLOXACILLIN

Powder for solution

for

injection/infusion x

250mg/vial

FLUCLOXACILLIN (as

FLUCLOXACILLIN SODIUM

MONOHYDRATE)

Box x 10 vials

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR;

ISTITUTO BIOCHIMICO

ITALIANO GIOVANNI

LORENZINI SPA - ITALI;

LABESFAL-LABORATORIO

DE ESPECIALIDADES

FARMACEUTICAS ALMIRO

SA - PORTUGALI; CP

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR

REGJ.

664/21.12.2010

28

2143

FLUCLOXACILLIN

Powder for solution

for

injection/infusion x

500mg/vial

FLUCLOXACILLIN (as

FLUCLOXACILLIN SODIUM

MONOHYDRATE)

Box x 10 vials

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR;

ISTITUTO BIOCHIMICO

ITALIANO GIOVANNI

LORENZINI SPA - ITALI;

LABESFAL-LABORATORIO

DE ESPECIALIDADES

FARMACEUTICAS ALMIRO

SA - PORTUGALI; CP

PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR

REGJ.

664/21.12.2010

35

Page 288

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289

2144

PROSULF

Solution for

injection x

50mg/5ml

PROTAMINE SULPHATEBox x 10

ampoules x 5ml

WOCKHARDT UK LTD -

MBRETERIA E

BASHKUAR

WOCKHARDT UK LTD -

MBRETERIA E BASHKUAR;

CP PHARMACEUTICALS LTD

- MBRETERIA E BASHKUAR;

ECZACIBASI ZENTIVA

SAGLIK URUNLERI SAN. VE

TIC. ANONIM SIRKETI -

TURQI

REGJ.

310/17.05.2010

57

2145

VANCOMYCIN

Powder for solution

for infusion x

500mg/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE)

Box x 1 vial

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR;

LABORATORIO REIG JOFRE

SA - SPANJE

REGJ.

664/21.12.2010

6

2146

VANCOMYCIN

Powder for solution

for infusion x

1g/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE)

Box x 1 vial

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR;

LABORATORIO REIG JOFRE

SA - SPANJE

REGJ.

664/21.12.2010

9

2147

ADENOSINESolution for

injection x 3mg/mlADENOSINE Box x 6 vials

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

CP PHARMACEUTICALS

LIMITED - MBRETERI E

BASHKUAR

REGJ.

140/19.03.20139

2148

FENPAEDOral suspension x

100mg/5mlIBUPROFEN

Box x 1 glass

bottle x 100ml

PINEWOOD

LABORATORIES LIMITED

- IRLANDE

PINEWOOD LABORATORIES

LIMITED - IRLANDE

REGJ.

664/21.12.20102.6

2149

DUAC GELGel x (50mg +

10mg)/g

ANHYDROUS BENZOYL

PEROXIDE (as BENZOYL

PEROXIDE HYDROUS

PH.EUR. X 66.7mg/g) +

CLINDAMYCIN (as

CLINDAMYCIN

PHOSPHATE x 12.8mg/g)

Box x 1 tube x

25g

"STIEFFEL

LABORATORIES (UK)

LTD" MBRETERI E

BASHKUAR

"STIEFFEL LABORATORIES

(IRLANDE) LIMITED"

IRLANDE

Regj.

384/ 17.06.2013

11.31

Page 289

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290

2150

ZENTEL Tablets x 400mg ALBENDAZOLE Box x 1 tablet

"GLAXOSMITHKLINE

SOUTH AFRICA LIMITED"

REPUBLIKA E AFRIKES

SE JUGUT, (regjistruar ne

France)

GLAXOSMITHKLINE SOUTH

AFRICA LIMITED REPUBLIKA

E AFRIKES SE JUGUT

Regj.

384/ 17.06.2013

1.36

2151

ZENTEL Oral suspension x

0.4g/10mlALBENDAZOLE

Box x 1 flacon x

10ml

"GLAXOSMITHKLINE

SOUTH AFRICA LIMITED"

REPUBLIKA E AFRIKES

SE JUGUT, (regjistruar ne

France)

GLAXOSMITHKLINE SOUTH

AFRICA LIMITED REPUBLIKA

E AFRIKES SE JUGUT

Regj.

384/ 17.06.2013

1.36

2152

ACTONEL once a

week

Film-coated tablets

x 35mg

RISEDRONATE SODIUM

(EQ. TO RISEDRONATE

32.5MG)

Box x 4

WARNER CHILCOTT

DEUTSCHLAND GMBH -

GJERMANI

NORWICH

PHARMACEUTICALS INC -

SHBA; WARNER CHILCOTT

DEUTSCHLAND GMBH -

GJERMANI; CHINOIN

PHARMACEUTICAL AND

CHEMICAL WORKS PRIVATE

CO. LTD - HUNGARI

REGJ.

662/21.12.2010

11.9

2153

AMARYL Tablets x 2mg GLIMEPIRIDE Box x 30

SANOFI - AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI - AVENTIS S.P.A -

ITALI

RIREGJ.

182/18.03.20094.9

2154

AMARYL Tablets x 4mg GLIMEPIRIDE Box x 30

SANOFI - AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI - AVENTIS S.P.A -

ITALI

RIREGJ.

182/18.03.20096.5

2155

AMARYL Tablets x 1mg GLIMEPIRIDE Box x 30

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-AVENTIS SPA -

ITALI

RIREGJ.

325/15.05.20133.2

2156

AMARYL Tablets x 3mg GLIMEPIRIDE Box x 30

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-AVENTIS SPA -

ITALI

RIREGJ.

325/15.05.20135.5

2157

AMIKOZIT

Solution for

iinjection x

500mg/2ml

AMIKACIN (as AMIKACIN

SULPHATE)Box x 1 vial ZENTIVA S.A - RUMANI ZENTIVA S.A - RUMANI

REGJ.

307/07.05.20131.6

Page 290

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291

2158

AZITROXFilm-coated tablets

x 500mg

AZITHROMYCINE (as

AZITHROMYCINE

DIHYDROCHLORIDE x

524.052mg)

Box x 3ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S - REPUBLIKA

CEKE

REGJ.

452/31.10.2011

5

2159

CLAFORAN

Powder and

solvent for solution

for I.M-I.V injection

x 1.0g/vial

CEFOTAXIME (as

CEFOTAXIME SODIUM x

1.048g)

Box x 1 vial of

powder + glass

ampoule x 4ml

water for

injection

SANOFI-AVENTIS

FRANCE - FRANCE

PATHEON UK LIMITED -

MBRETERI E BASHKUAR

REGJ.

156/20.04.2011

3.3

2160

CLEXANE

Solution for

injection x 2000 IU

anti-Xa/0.2ml

ENOXAPARIN SODIUM

(EQUIVALENT TO 20MG)

Box x 2 pre-

filled syringes x

0.2ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PHARMACEUTICAL

AND CHEMICAL WORKS

PRIVATE CO/LTD - HUNGARI

RIREGJ.

532/14.10.2009

4.15

2161

CLEXANE

Solution for

injection x 6000 IU

anti-Xa/0.6ml

ENOXAPARIN SODIUM

(EQUIVALENT TO 60MG)

Box x 2 pre-

filled syringes x

0.6ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PHARMACEUTICAL

AND CHEMICAL WORKS

PRIVATE CO/LTD - HUNGARI

RIREGJ.

392/01.07.2009

9.5

2162

CLEXANE

Solution for

injection x 8000 IU

anti-Xa/0.8ml

ENOXAPARIN SODIUM

(EQUIVALENT TO 80MG)

Box x 2 pre-

filled syringes x

0.8ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PHARMACEUTICAL

AND CHEMICAL WORKS

PRIVATE CO/LTD - HUNGARI

RIREGJ.

532/14.10.2009

10.78

2163

CLEXANE

Solution for

injection x 10000

IU anti-Xa/1ml

ENOXAPARIN SODIUM

(EQUIVALENT TO 100MG)

Box x 2 pre-

filled syringes x

1ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PHARMACEUTICAL

AND CHEMICAL WORKS

PRIVATE CO/LTD - HUNGARI

RIREGJ.

532/14.10.2009

12.72

Page 291

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292

2164

CORDARONE

Solution for I.V.

injection x

150mg/3ml

AMIODARONE

HYDROCHLORIDE

Box x 6

ampoules s 3ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE

RIREGJ.

325/15.05.20133.7

2165

COAPROVEL

Film-coated tablets

x (150mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

SANOFI PHARMA

BRISTOL-MYERS

SQUIBB SNC - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PRIVATE CO. LTD -

HUNGARI; SANOFI

SYNTHELABO LIMITED -

MBRETERI E BASHKUAR

(APL: BRISTOL-MYERS

SQUIBB INTERNATIONAL

CORPORATION - FRANCE)

REGJ.

588/29.10.2010

8.36

2166

COAPROVEL

Film-coated tablets

x (300mg +

12.5mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

SANOFI PHARMA

BRISTOL-MYERS

SQUIBB SNC - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PRIVATE CO. LTD -

HUNGARI; SANOFI

SYNTHELABO LIMITED -

MBRETERI E BASHKUAR

(APL: BRISTOL-MYERS

SQUIBB INTERNATIONAL

CORPORATION - FRANCE)

REGJ.

588/29.10.2010

11.38

2167

COAPROVELFilm-coated tablets

x (300mg + 25mg)

IRBESARTAN +

HYDROCHLOROTHIAZIDEBox x 28

SANOFI PHARMA

BRISTOL-MYERS

SQUIBB SNC - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE;

CHINOIN PRIVATE CO. LTD -

HUNGARI; SANOFI

SYNTHELABO LIMITED -

MBRETERI E BASHKUAR

(APL: BRISTOL-MYERS

SQUIBB INTERNATIONAL

CORPORATION - FRANCE)

REGJ.

588/29.10.2010

11.38

Page 292

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293

2168

ELOXATIN

Concentrate for

solution for infusion

x 5mg/ml

OXALIPLATINBox x 1 vial x

10ml

SANOFI-AVENTIS

FRANCE - FRANCE

AVENTIS PHARMA

DAGENHAM - MBRETERI E

BASHKUAR; SANOFI-

AVENTIS DEUTSCHLAND

GMBH - GJERMANI

REGJ.

369/17.06.2009

18

2169

ELOXATIN

Concentrate for

solution for infusion

x 5mg/ml

OXALIPLATIN Box x 1 vial x

20ml

SANOFI-AVENTIS

FRANCE - FRANCE

AVENTIS PHARMA

DAGENHAM - MBRETERI E

BASHKUAR; SANOFI-

AVENTIS DEUTSCHLAND

GMBH - GJERMANI

REGJ.

369/17.06.2009

35

2170

ENTEROGERMINAOral suspension x

2 billion/5ml

SPORES OF

POLYANTIBIOTIC-

RESISTANT B. CLAUSII

Box x 10 flacons

x 5ml

SANOFI-AVENTIS SPA -

ITALI

LABORATOIRE UNITHER -

FRANCE; SANOFI-AVENTIS

SPA - ITALI

REGJ.

156/20.04.2011

4.5

2171

HELIDESGastro - resistant

capsules x 20mg

ESOMEPRAZOLE (eq. to

ESOMEPRAZOLE

MAGNESIUM DIHYDRATE x

21.69mg)

Box x 28ZENTIVA K.S -

REPUBLIKA CEKE

ETHYPHARMA - FRANCE;

FAMAR L'AIGLE - FRANCE;

LAPHAL INDUSTRIES -

FRANCE; ROTTENDORF

PHARMA - FRANCE; S.C.

ZENTIVA S.A - RUMANI

REGJ.

307/07.05.2013

5.5

2172

KAPIDINFilm - coated

tablets x 20mg

LERCANIDIPINE

HYDROCHLORIDEBox x 28

ZENTIVA K.S -

REPUBLIKA CEKE

ACTAVIS LTD - MALTE;

ACTAVIS HF - ISLANDE;

BALKANPHARMA -

DUPNITSA AD - BULLGARI

(APL: SANOFI - AVENTIS

BULGARIA LTD - BULLGARI)

REGJ.

307/07.05.2013

7

2173

LANTUS

Solution for

injection x 100

Units/ml

INSULIN GLARGINEBox x 5

cartridges x 3ml

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

REGJ.

451/31.10.201155.13

2174

MAALOX

STOMACH PAINS

Oral suspension x

(4g + 3.5g) / 100ml

MAGNESIUM HYDROXIDE

+ ALUMINIUM HYDROXIDE

Box x 1 glass

bottle x 250ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-AVENTIS SPA -

ITALIREGJ. 98/22.02.2010

2.4

Page 293

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294

2175

MAALOX

STOMACH PAINS

Chewable tablets x

(400mg + 400mg)

MAGNESIUM HYDROXIDE

+ ALUMINIUM HYDROXIDEBox x 40

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-AVENTIS SPA -

ITALIREGJ. 98/22.02.2010

2.4

2176

MAGNE B6

Oral solution x

(0.186g + 0.936g +

0.01g)

MAGNESIUM LACTATE

DIHYDRATE + MAGNESIUM

PIDOLATE + PYRIDOXINE

HYDROCHLORIDE

Box x 10

ampoules x

10ml

SANOFI-AVENTIS

FRANCE - FRANCE

COOPERATION

PHARMACEUTIQUE

FRANCAISE - FRANCE;

SANOFI WINTHROP

INDUSTRIE - FRANCE

REGJ.

153/04.03.2009

1.9

2177

MAGNE B6Coated tablet x

470mg + 5mg

MAGNESIUM LACTATE

DIHYDRATE +

PYRIDOXINE

HYDROCHLORIDE

Box x 50 SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE

REGJ.

153/04.03.2009

3.7

2178NEUROL Tablets x 0.25mg ALPRAZOLAM Box x 30

ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S - REPUBLIKA

CEKE

REGJ.

307/07.05.2013 2

2179NEUROL Tablets x 0.5mg ALPRAZOLAM Box x 30

ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S - REPUBLIKA

CEKE

REGJ.

307/07.05.2013 2.5

2180

PARALEN GRIP

HORKY NAPOJ

Granules for

suspension x

(650mg +

10mg/sachet)

PARACETAMOL +

PHENYEPHRINE

HYDROCHLORIDE

Box x 6 sachetsZENTIVA K.S -

REPUBLIKA CEKE

BIOMEDICA S.R.O -

REPUBLIKA CEKE; ZENTIVA

K.S. - REPUBLIKA CEKE

REGJ.

307/07.05.2013

1.3

2181

PLAVIXFilm coated tablets

x 300mg

CLOPIDOGREL (AS

CLOPIDOGREL

HYDROGEN SULPHATE)

Box x 30

SANOFI PHARMA

BRISTOL-MYERS

SQUIBB SNC - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE (APL:

SANOFI-AVENTIS R & D -

FRANCE)

REGJ.

192/19.03.2009

69.9

2182

ROSUCARDFilm-coated tablets

x 10mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 10.4mg)

Box x 30ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S - REPUBLIKA

CEKE

REGJ.

452/31.10.20117

2183

ROSUCARDFilm-coated tablets

x 20mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 20.8mg)

Box x 30ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S - REPUBLIKA

CEKE

REGJ.

452/31.10.201110.5

2184

ROSUCARDFilm-coated tablets

x 40mg

ROSUVASTATIN (as

ROSUVASTATIN CALCIUM

x 41.6mg)

Box x 30ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S - REPUBLIKA

CEKE

REGJ.

452/31.10.201112

2185

ROVAMYCINEFilm coated tablets

x 1 500 000 I.U.SPIRAMYCIN Box x 16

SANOFI-AVENTIS

FRANCE - FRANCEFAMAR LYON - FRANCE

REGJ.

656/20.11.20086

2186SOLIAN

Scored Tablets x

100mgAMISULPRIDE Box x 30

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE

REGJ.

427/04.08.2009 9.23

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295

2187SOLIAN

Scored Tablets x

200mgAMISULPRIDE Box x 30

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE

REGJ.

427/04.08.2009 15

2188

SOLIAN

Scored Film

Coated Tablets x

400mg

AMISULPRIDE Box x 30SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE

REGJ.

427/04.08.200918

2189

SOLIANOral Solution x

100mg/mlAMISULPRIDE

Box x 1 flacon x

60ml

SANOFI-AVENTIS

FRANCE - FRANCE

UNITHER LIQUID

MANUFACTURING - FRANCE

REGJ.

427/04.08.200916.5

2190

STILNOX

Film-coated,

scored tablets x

10mg

ZOLPIDEM TARTRATE Box x 20SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE

RIREGJ.

266/12.06.20123.8

2191

TAVANICFilm - coated

tablets x 500mg

LEVOFOLXACIN (as

LEVOFLOXACIN

HEMIHYDRATES x

512.460mg)

Box x 5

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI WINTHROP

INDUSTRIE - FRANCE

RIREGJ.

325/15.05.2013

8.2

2192

TAVANICSolution for

infusion x 5mg/ml

LEVOFOLXACIN (as

LEVOFLOXACIN

HEMIHYDRATES x

512.460mg/100ml)

Box x 1 vial x

100ml

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI WINTHROP

INDUSTRIE - FRANCE

RIREGJ.

325/15.05.2013

26.52

2193

TAXOTERE

Concentrate and

solvent for solution

for infusion x

20mg/0.5ml

DOCETAXEL

(ANHYDROUS)

Box x (1 single-

dose vial of

concentrate + 1

single-dose vial

of solvent)

AVENTIS PHARMA S.A. -

FRANCE

AVENTIS PHARMA

DAGENHAM - MBRETERI E

BASHKUAR

RIREGJ.

223/08.04.2009

40

2194

TAXOTERE

Concentrate for

solution for infusion

x 80mg/4ml

DOCETAXEL TRIHYDRATEBox x 1 vial x

4ml

AVENTIS PHARMA SA -

FRANCE

AVENTIS PHARMA

DAGENHAM - MBRETERI E

BASHKUAR

REGJ.

189/12.05.2011

80

2195

TELFASTFilm - coated

tablets x 120mg

FEXOFENADIN

HYDROCHLORIDE (eq. to

112mg FEXOFENADIN)

Box x 20

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI - SYNTHELABO LTD -

MBRETERI E BASHKUAR

RIREGJ.

325/15.05.2013

2.81

2196

TRITACE Tablets x 5mg RAMIPRIL Box x 28

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-AVENTIS SPA -

ITALI

RIREGJ.

166/19.04.20124.62

2197

TRITACE Tablets x 10mg RAMIPRIL Box x 28

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-AVENTIS SPA -

ITALI

RIREGJ.

166/19.04.20125.47

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296

2198

RENVELAFilm coated tablets

x 800mgSEVELAMER CARBONATE

Plastic bottle x

180

GENZYME EUROPE BV -

HOLLANDE

GENZYME IRELAND LIMITED

- IRLANDE; GENZYME

LIMITED - MBRETERI E

BASHKUAR

REGJ.

375/18.06.2010

190

2199

ZENCOPANGastro - resistant

tablets x 20mg

PANTOPRAZOLE (eq. to

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

22.575mg)

Box x 28ZENTIVA K.S -

REPUBLIKA CEKE

AET LABORATORIES

PVT.LTD - INDI; CLINTEX-

PRODUCTOS

FARMACEUTICOS SA -

PORTUGALI;

PRZEDSIEBIORSTWO

FARMACEUTYCZNE JELFA

SA - POLONI; SOFARIMEX-

INDUSTRIA QUIMICA E

FARMACEUTICA SA -

PORTUGALI; FARMA - APS -

PORTUGALI; ROTTENDORF

PRODUCTION GMBH -

GJERMANI; ROTTENDORF

VERPACKUNG GMBH -

GJERMANI; ARTESAN GMBH

& CO.KG - GJERMANI;

SANOFI - AVENTIS SP. Z.O.O

- POLONI; ROTTENDORF

PHARMA GMBH - GJERMANI

REGJ.

307/07.05.2013

4

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297

2200

ZENCOPANGastro - resistant

tablets x 40mg

PANTOPRAZOLE (eq. to

PANTOPRAZOLE SODIUM

SESQUIHYDRATE x

45.150mg)

Box x 28ZENTIVA K.S -

REPUBLIKA CEKE

AET LABORATORIES

PVT.LTD - INDI; CLINTEX-

PRODUCTOS

FARMACEUTICOS SA -

PORTUGALI;

PRZEDSIEBIORSTWO

FARMACEUTYCZNE JELFA

SA - POLONI; SOFARIMEX-

INDUSTRIA QUIMICA E

FARMACEUTICA SA -

PORTUGALI; FARMA - APS -

PORTUGALI; ROTTENDORF

PRODUCTION GMBH -

GJERMANI; ROTTENDORF

VERPACKUNG GMBH -

GJERMANI; ARTESAN GMBH

& CO.KG - GJERMANI;

SANOFI - AVENTIS SP. Z.O.O

- POLONI; ROTTENDORF

PHARMA GMBH - GJERMANI

REGJ.

307/07.05.2013

8

2201

TRIAPIN

Film-coated tablets

x (5mg + 5mg)

RAMIPRIL + FELODIPINE Box x 28

SANOFI - AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

ASTRAZENECA AB - SUEDI,

PHARMACEUTICAL AND

CHEMICAL WORKS PRIVATE

CO. LTD. - HUNGARI

REGJ.

284/11.05.2009

5.5

2202

MEXIAFilm-coated tablets

x 10mg

MEMANTINE

HYDROCHLORIDEBox x 100

NOBEL ILAC

PAZARLAMA VE SANAYII

LTD STI- TURQI

NOBEL ILAC SANAYII VE

TICARET AS - TURQIREGJ. 3/07.01.2013

50

2203

VANCOMYCIN

"LEDERLE"

Powder for oral

solution and for

solution for infusion

x 500mg/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE x

501.1mg)

Box x 5 vialsRIEMSER ARZNEIMITTEL

AG - GJERMANIHIKMA ITALIA SPA - ITALI

REGJ.

311/17.05.2010

32.5

Page 297

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298

2204

VANCOMYCIN

"LEDERLE"

Powder for oral

solution and for

solution for infusion

x 1000mg/vial

VANCOMYCIN (as

VANCOMYCIN

HYDROCHLORIDE x

1002.1mg)

Box x 5 vialsRIEMSER ARZNEIMITTEL

AG - GJERMANIHIKMA ITALIA SPA - ITALI

REGJ.

311/17.05.2010

45

2205

NIBIXHard capsules x

400mgIMATINIB Box x 30

"ADAMED SP. Z.O.O."

POLONI

"PABIANICKIE ZAKLADY

FARMACEUTYCZNE POLFA

SA" POLONI

Regj.481/09.09.2013

1480

2206 IMAKREBIN

Film-coated tablets

x 400mg

IMATINIB (as IMATINIB

MESILATE) Box x 30

ALVOGEN IPCo. S.ar.1 -

LUKSEMBURG

REMEDICA LTD - QIPRO;

PHARMADOX HEALTHCARE

LTD - MALTE

REGJ

422/11.07.2013;

Nd/U.477/09.09.2013 1200

2207

COUMEKINCapsules x (12mg

+ 25mg)

OLANZAPINE +

FLUOXETINEBox x 30

"ABDI IBRAHIM ILAC SAN.

VE TIC. A.S." TURQI

"ABDI IBRAHIM ILAC SAN. VE

TIC. A.S." TURQI

Regj.422/11.07.2013;

VARIACION EMRI

TREGTAR 3892/1

/26.12.201316

2208

COUMEKINCapsules x (12mg

+ 50mg)

OLANZAPINE +

FLUOXETINEBox x 30

"ABDI IBRAHIM ILAC SAN.

VE TIC. A.S." TURQI

"ABDI IBRAHIM ILAC SAN. VE

TIC. A.S." TURQI

Regj.422/11.07.2013;

VARIACION EMRI

TREGTAR

805/1/11.112013 16

2209

MORFINA

COLRIDRATO

MONICO

Solution for

injection x 20mg

/ml

MORPHINE

HYDROCHLORIDE

Box x 5

ampoules x 1 ml

"MONICO SPA" ITALI "MONICO SPA" ITALI Regj.422/11.07.2013

9

2210 GLORIXONE

Powder and

solvent for solution

for IM injection x

1000mg/vial

CEFTRIAXONE (as

CEFTRIAXONE SODIUM

TRISESQUIHYDRATE x

1193mg/vial)

Box x (1 vial

with powder + 1

ampoule with

solvent x 3.5ml) MEDICUS SA - GREQI

ANFARM HELLAS SA -

GREQI; FAMAR SA - GREQI;

HELP SA - GREQI

REGJ

422/11.07.2013 3.6

2211

TELFASTFilm-coated tablets

x 180 mg

FEXOFENADINE

HYDROCHLORIDE (eq. to

168mg FEXOFENADINE )

Box x 10

SANOFI-AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-SYNTHELABO LTD. -

MBRETERI E BASHKUAR

RIREGJ.

663/06.12.2013

4.24

Page 298

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299

2212

BERODUAL

DOSIERAEROSOL

Ap metered

aerosol, solution

and propellant x

(0.02mg + 0.05mg)

/ puff

IPRATROPIUM BROMIDE

(as IPRATROPIUM

BROMIDE MONOHYDRATE

x 0.021mg) + FENOTEROL

HYDROBROMIDE

Box x flacon x

10ml - 200

doses

BOEHRINGER

INGELHEIM RCV GMBH &

CO.KG - AUSTRI

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG -

GJERMANI (APL:

BOEHRINGER INGELHEIM

PHARMA GMBH & CO.KG ON

BEHALF OF BOEHRINGER

INGELHEIM INTERNATIONAL

GMBH - GJERMANI)

RIREGJ.

578/02.11.2009 6.83

2213

ELIDELCream x 10mg/g

(1%)PIMECROLIMUS

Box x tube x

15g

MEDA PHARMA GMBH &

CO. KG - GJERMANI

NOVARTIS PHARMA

PRODUKTIONS GMBH -

GJERMANI

RIREGJ.

663/06.12.201316

2214

ADVANTAN

OINTMENT

Ointment x 0.1%

(0.1g/100g)

METHYLPREDNISOLONE

ACEPONATE

Box x 1 tube x

15g

INTENDIS GMBH -

GJERMANI

INTENDIS MANUFACTURING

SPA - ITALI (APLIKANT:

INTENDIS GMBH -

GJERMANI)

RIREGJ.

251/23.04.2009

2.78

2215 NOOTROPIL

Film coated tablets

x 800mg PIRACETAM Box x 30

UCB PHARMA SA -

BELGJIKE

UCB PHARMA SA -

BELGJIKE

RIREGJ

423/11.07.2013 3

2216 NOOTROPIL

Film coated tablets

x 1200mg PIRACETAM Box x 20

UCB PHARMA SA -

BELGJIKE

UCB PHARMA SA -

BELGJIKE

RIREGJ

423/11.07.2013 3

2217 ALGOFREN

Film-coated tablets

x 600mg IBUPROFEN Box x 20

IOULIA & IRENE TSETI

PHARMACEUTICAL

LABORATORIES SA -

"INTERMED S.A." - GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

549/31.10.2012 1.33

2218 ALGOFREN Syrup x 100mg/5ml IBUPROFEN x 20mg/ml

Box x 1 glass

bottle x 150ml

IOULIA & IRENE TSETI

PHARMACEUTICAL

LABORATORIES S.A.

"INTERMED S.A." - GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES S.A. -

GREQI

RIREGJ.

96/16.03.2011 2.21

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300

2219 SUPERO

Powder and

solvent for solution

for IM injection x

750mg/vial

CEFUROXIME (as

CEFUROXIME SODIUM X

789mg/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent x 3ml

(Lidocaine

hydrochloride

15mg/3ml) LIFEPHARMA SPA - ITALI

MITIM SRL - ITALI,

LABESFAL LABORATORIOS

ALMIRO SA - PORTUGALI,

ITALFARMACO SPA - ITALI

RIREGJ

333/29.08.2011 2.5

2220 FLEXEN

Powder and

solvent for solution

for I.M injection x

100mg/2.5ml KETOPROFEN

Box x 6

ampoules of

powder + 6

ampoules of

solvent x 2.5ml

ITALFARMACO SPA -

ITALI

ITALFARMACO SPA - ITALI;

HIKMA ITALIA SPA - ITALI;

BIOLOGICI ITALIA

LABORATORIES SPA - ITALI;

ALFA WASSERMANN SPA -

ITALI

RIREGJ

471/11.11.2011 3.96

2221 FLEXEN Gel x 2.5% KETOPROFEN

Box x 1 tube x

50g

ITALFARMACO SPA -

ITALI

FRANCIA FARMACEUTICI

INDUSTRIA FARMACO

BIOLOGICA SRL - ITALI;

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

RIREGJ

167/19.04.2012 3.7

2222 NATECAL D3

Chewable tablets x

(600mg + 400 I.U.)

CALCIUM (as CALCIUM

CARBONATE x 1500 mg) +

COLECALCIFEROL

Box x 1 bottle x

60

ITALFARMACO SPA -

ITALI

FINE FOODS N.T.M. SPA -

ITALI, ITALFARMACO SPA -

ITALI

RIREGJ.

43/28.01.2009 4.803

2223 FOLIDEX Tablets x 400mcg FOLIC ACID Box x 28

ITALFARMACO SPA -

ITALI ITALFARMACO SPA - ITALI

REGJ.

575/28.10.2010 2.2

2224

GLIATILINSoft capsules x

400mgCHOLINE ALFOSCERATE Box x 14

ITALFARMACO SPA -

ITALI

ITALFARMACO SPA - ITALI,

CATALENT ITALY SPA -

ITALI, CAPSUGEL

PLOERMEL - FRANCE

RIREGJ.

339/03.06.2009

8.851

2225

GLIATILIN

Solution for

injection x

1000mg/4ml

CHOLINE ALFOSCERATEBox x 5 vials x

4ml

ITALFARMACO SPA -

ITALIITALFARMACO SPA - ITALI

RIREGJ.

339/03.06.20099.45

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301

2226 DELTAZIME

Powder and

solvent for solution

for injection I.M. x 1

g/3 ml

CEFTAZIDIME (as

CEFTAZIDIME

PENTAHYDRATE x 1.164 g)

Box x (1 Vial of

powder + 1

Ampoule of

solvent x 3 ml)

LABORATORIO

FARMACEUTICO CT SRL -

ITALI

LABORATORIO

FARMACEUTICO CT SRL -

ITALI, GET SRL - ITALI REGJ. 42/28.01.2009 4.85

2227

CITIFLUXNebulising solution

x 0.1 %FLUNISOLIDE

Box x 1 Flacon

x 30 ml

LABORATORIO

FARMACEUTICO CT SRL -

ITALI

FARMILA-THEA

FARMACEUTICI SPA - ITALIREGJ. 42/28.01.2009

16

2228 FLOLID Tablets x 100mg NIMESULIDE Box x 30

LABORATORIO

FARMACEUTICO C.T. -

ITALI

LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI; GET SRL - ITALI

REGJ.

421/29.07.2009 2.1

2229 FLOLID

Granules for oral

suspension x

100mg NIMESULIDE

Box x 30

sachets

LABORATORIO

FARMACEUTICO C.T.

SRL - ITALI

LABORATORIO

FARMACEUTICO C.T. - ITALI;

GET SRL - ITALI; LAMP S.

PROSPERO SPA - ITALI

REGJ.

421/29.07.2009 2.1

2230 CHEMACIN

Solution for

injection x

500mg/2ml

AMIKACIN (as AMIKACIN

SULPHATE x 667.50mg)

Box x 1 vial x

2ml

LABORATORIO

FARMACEUTICO C.T.

SRL - ITALI

LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI; GET SRL - ITALI

REGJ.

290/06.05.2010 1.2

2231 CHEMACIN

Solution for

injection x

500mg/2ml

AMIKACIN (as AMIKACIN

SULPHATE x 667.50mg)

Box x 5

ampoules

LABORATORIO

FARMACEUTICO C.T.

SRL - ITALI

LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI; GET SRL - ITALI

REGJ.

290/06.05.2010 5.35

2232 CHEMACIN

Solution for

injection x 1g/4ml

AMIKACIN (as AMIKACIN

SULPHATE x 1335mg)

Box x 1 vial x

4ml

LABORATORIO

FARMACEUTICO C.T.

SRL - ITALI

LABORATORIO

FARMACEUTICO C.T. SRL -

ITALI; GET SRL - ITALI

REGJ.

290/06.05.2010 2.4

2233 MIOZAC

Solution for

infusion x

250mg/20ml

DOBUTAMIN (as

DOBUTAMIN

HYDROCHLORIDE x

280.28MG)

Box x 1 flacon x

20ml

FISIOPHARMA SRL -

ITALI FISIOPHARMA SRL - ITALI

REGJ.

284/11.05.2009 5.6

2234

CLORAMFENICOL

O FISIOPHARMA

Powder and

solvent for solution

for injection x

1g/vial-10ml

CHLORAMPHENICOL (as

CHLORAMPHENICOL

SODIUM SUCCINATE x

1.377g)

Box x 50 vials

(for hospital

use)

FISIOPHARMA SRL -

ITALI FISIOPHARMA SRL - ITALI

REGJ.

575/28.10.2010 60

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302

2235

ARGENTO

PROTEINATO

NOVA ARGENTIA

Nasal drops,

solution x 0.5%

(w/w) PROTEINATED SILVER

Box x 1 flacon x

10ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

RIREGJ

48/30.01.2012 1.069

2236

ARGENTO

PROTEINATO

NOVA ARGENTIA

Nasal drops,

solution x 1% (w/w) PROTEINATED SILVER

Box x 1 flacon x

10ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

RIREGJ

48/30.01.2012 1.337

2237

ARGENTO

PROTEINATO

NOVA ARGENTIA

Nasal drops,

solution x 2% (w/w) PROTEINATED SILVER

Box x 1 flacon x

10ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

RIREGJ

48/30.01.2012 1.496

2238

SODIO

BICARBONATO

NOVA ARGENTIA Tablets x 500mg SODIUM BICARBONATE Box x 50

"INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA" - ITALY

"INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA" - ITALY

RIREGJ

332/29.08.2011 1.792

2239

METILTIONINIO

NOVA ARGENTIA

Cutaneous solution

x 1% (w/w)

METHYLTHIONINIUM

CHLORIDE (BLU DI

METILEN)

Box x 1 flacon x

20ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA S.P.A. - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA S.P.A. -

ITALI

REGJ

384/17.06.2013 1.75

2240

METILROSANILINI

O CLORURO

NOVA ARGENTIA

Cutaneous solution

x 1% (w/w)

METHYLROSANILINIUM

CHLORIDE (CRYSTAL

VIOLET)

Box x 1 flacon x

25ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA S.P.A. - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA S.P.A. -

ITALI

REGJ

384/17.06.2013 1.75

2241

DIMENIDRINATO

NOVA ARGENTIA Tablets x 50mg DIMENHYDRINATE Box x 15

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

RIREGJ

48/30.01.2012 1.067

2242

FOSFATO

SODICO ACIDO

NOVA ARGENTIA

Rectal solution x

(16 % + 6 %)

MONOBASIC SODIUM

PHOSPHATE

MONOHYDRATE +

DIBASIC SODIUM

PHOSPHATE

HEPTAHYDRATE

Box x 1 flacon x

120 ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

REGJ.

569/24.10.2008

1.67

2243

FUSCINA FENICA

NOVA ARGENTIA

Cutaneous solution

x (4g + 0.3g + 10g

+ 1g)/100g

PHENOL LIQUID + BASIC

FUCHSIN + RESORCIN +

BORIC ACID

Box x 1 flacon x

30ml

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA S.P.A. - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA S.P.A. -

ITALI

REGJ

384/17.06.2013 1.822

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303

2244

PARACETAMOLO

NOVA ARGENTIA Tablets x 500mg PARACETAMOL Box x 20

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA S.P.A. - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA S.P.A. -

ITALI

REGJ

384/17.06.2013 0.87

2245

PROMETAZINA

NOVA ARGENTIA Cream x 2% (w/w)

PROMETHAZINE BASE (as

PROMETHAZINE

HYDROCHLORIDE x

2.25g/100g)

Box x 1 tube x

30g

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA S.P.A. - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA S.P.A. -

ITALI

REGJ

384/17.06.2013 1.65

2246

ACIDO

SALICILICO NOVA

ARGENTIA Ointment x 5% SALICYLIC ACID

Box x tube x

30g

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

RIREGJ

458/19.08.2013 1.643

2247

ZOLFO E ACIDO

SALICILICO NOVA

ARGENTIA

Ointment x (16% +

4%) w/w

PRECIPITATED SULFUR +

SALICYLIC ACID

Box x 1 tube x

30g

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA S.P.A. - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA S.P.A. -

ITALI

REGJ

384/17.06.2013 1.587

2248

VALERIANA

NOVA ARGENTIA

Coated tablets x

50mg

HYDROALCOHOLIC

EXTRACT (CONTAINING

0.8% VALERENIC ACID) Box x 30

INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA - ITALI

INDUSTRIA FARMACEUTICA

NOVA ARGENTIA SPA - ITALI

RIREGJ

458/19.08.2013 2.205

2249

ZINCO OSSIDO

NOVA ARGENTIA

Ointment x

10%(w/w) ZINC OXIDE

Box x 1 tube x

30g

"INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA" - ITALY

"INDUSTRIA

FARMACEUTICA NOVA

ARGENTIA SPA" - ITALY

RIREGJ

332/29.08.2011 1.445

2250 COROSAN Tablets x 75mg DIPYRIDAMOLE Box x 30

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

LABORATORIO

FARMACOLOGICO

MILANESE S.R.L - ITALI

REGJ

451/13.08.2013 1.941

2251 EUCARBON

Tablets x (105mg +

25mg + 180mg +

50mg + 0.5mg +

0.5mg)

SENNAE FOLIUM + RHEI

RADIX (EXTRACT) +

CARBO (LIGNI) + SULPHUR

(PURIFIED) + MENTHAE

PIPERITAE AETHEROLEUM

+ FOENICULI

AETHEROLEUM Box x 30

F. TRENKA CHEMISCH-

PHARMAZEUTISCHE

FABRIK GMBH - AUSTRI

PHARMAZEUTISCHE

FABRIK MONTAVIT GESMBH

- AUSTRI

RIREGJ

260/12.06.2012 3.12

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304

2252

AMOXICILINA/ACI

DO

CLAVULANICO

SALA

Powder for solution

for injection x (1g +

200mg)/vial

AMOXYCILLIN (as SODIUM

SALT) + CLAVULANIC ACID

(as POTASSIUM SALT)

Box x 1 vial x

20ml

LABORATORIOS RAMON

SALA S.L - SPANJE

LABORATORIO REIG JOFRE

S.A - SPANJE REGJ. 21/13.01.2011 3.2

2253

CEFTAZIDIMA

SALA

Powder and

solvent for solution

for injection x

1g/vial

CEFTAZIDIME

PENTAHYDRATE

Box x 1 vial with

powder + 1

ampoule x 10ml

water for

injection

LABORATORIOS RAMON

SALA S.L - SPANJE

B. BRAUN MEDICAL S.A -

SPANJE; LDP

LABORATORIOS TORLAN

S.A - SPANJE REGJ. 21/13.01.2011 3.5

2254

CEFTRIAXONA

SALA

Powder and

solvent for solution

for IV injection x

1g/vial CEFTRIAXONE SODIUM

Box x 1 vial with

powder + 1

ampoule x 10ml

water for

injection

LABORATORIOS RAMON

SALA S.L - SPANJE

LABORATORIO REIG JOFRE

S.A - SPANJE REGJ. 21/13.01.2011 3

2255

BABY LUUF

BALSAM

Balsam x (15mg +

40mg + 10mg)/g

ETHEREAL EUCALYPTUS

OIL + PURIFIED ETHEREAL

TERPENTINE OIL +

ETHEREAL THYME OIL

Box x 1 glass

bottle x 30g

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH -

AUSTRI

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH - AUSTRI

RIREGJ.

190/12.05.2011 2.827

2256

KINDER LUUF

BALSAM

Balsam x (50mg +

27.5mg + 15mg +

50mg + 2.5mg/g

CAMPHOR + MENTHOL +

ETHEREAL EUCALYPTUS

OIL + RECTIFIED

ETHEREAL TERPENTINE

OIL + THYMOL

Box x 1 glass

bottle x 30g

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH -

AUSTRI

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH - AUSTRI

RIREGJ.

190/12.05.2011 2.827

2257 LUUF

Nasal spray,

solution x (1mg +

1mg)/ml

NAPHAZOLINE

HYDROCHLORIDE +

DIPHENHYDRAMINE

HYDROCHLORIDE

Box x 1

polyethylene

spray bottle x

15ml

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH -

AUSTRI

APOMEDICA

PHARMAZEUTISCHE

PRODUKTE GMBH - AUSTRI

RIREGJ.

190/12.05.2011 2.7078

2258

INDOMETACIN Capsules x 25mg INDOMETACIN Box x 28

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

REGJ. 61/06.02.2013

3.08

2259

INDOMETACIN Capsules x 50mg INDOMETACIN Box x 28

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

REGJ. 61/06.02.2013

3.64

2260

METRONIDAZOLE Tablets x 200mg METRONIDAZOLE Box x 21

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

REGJ. 61/06.02.2013

2.94

Page 304

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305

2261

METRONIDAZOLE Tablets x 400mg METRONIDAZOLE Box x 21

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

CRESCENT PHARMA

LIMITED - MBRETERI E

BASHKUAR

REGJ. 61/06.02.2013

3.57

2262

FOSAMAX ONCE

WEEKLYTablets x 70mg

ALENDRONATE SODIUM x

91.37mg (EQ. TO

ALENDRONATE x 70mg)

Box x 4 MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME (ITALIA)

SPA - ITALI

RIREGJ.

602/05.11.2010

11.7

2263 FOSAVANCE

Tablets x (70mg +

5600 IU)

ALENDRONIC ACID (as

ALENDRONATE SODIUM

TRIHYDRATE) x 70mg +

COLECALCIFEROL

(VITAMIN D3) x 5600 IU

Box x 1 wallet x

4 tablets

MERCK SHARP &

DOHME LTD - MBRETERI

E BASHKUAR

MERCK SHARP & DOHME

BV - HOLLANDE

REGJ.

311/17.05.2010 14.18

2264 RENITEC Tablets x 5mg ENALAPRIL MALEATE Box x 28

MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME LIMITED -

MBRETËRI E BASHKUAR

RIREGJ.

645/10.12.2010 2.66

2265 RENITEC Tablets x 10mg ENALAPRIL MALEATE Box x 28

MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME LIMITED -

MBRETËRI E BASHKUAR

RIREGJ.

645/10.12.2010 3.03

2266 CO-RENITEC

Tablets x (20mg +

12.5mg)

ENALAPRIL MALEATE +

HYDROCHLOROTHIAZIDE Box x 14

MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME -

MBRETËRI E BASHKUAR

RIREGJ.

645/10.12.2010 2.34

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306

2267 SILGARD

Suspension for

injection x (20µg +

40µg + 40µg +

20µg)/1 dose

(0.5ml)

HUMAN PAPILLOMA VIRUS

TYPE 6 L1 PROTEIN +

HUMAN PAPILLOMA VIRUS

TYPE 11 L1 PROTEIN +

HUMAN PAPILLOMA VIRUS

TYPE 16 L1 PROTEIN +

HUMAN PAPILLOMA VIRUS

TYPE 18 L1 PROTEIN

Box x 1 Pre-

filled Syringe x

0.5ml (1 dose) +

2 Needles

MERCK SHARP &

DOHME LTD - MBRETERI

E BASHKUAR

MERCK & CO. INC - SHBA;

MERCK SHARP & DOHME

BV - HOLLANDE

REGJ.

311/17.05.2010 104.56

2268 TIENAM

Powder for

perfusion x (500mg

+ 500mg)/vial

IMIPENEM ANHYDRATE (as

IMIPENEM

MONOHYDRATE) +

CILASTATIN ACID (as

CILASTATIN SODIUM)

Box x 25 vials

(for hospital

use)

MERCK SHARP &

DOHME CHIBRET -

FRANCE

LABORATOIRES MERCK

SHARP & DOHME-CHIBRET -

FRANCE

REGJ.

317/19.05.2010 188.85

2269 SINEMET CR

Controlled-release

tablets x (200mg +

50mg)

LEVODOPA + CARBIDOPA

ANHYDROUS (EQ. TO

CARBIDOPA x 54mg) Box x 100

MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME (ITALIA)

SPA - ITALI

RIREGJ.

291/06.05.2010 22.39

2270 SINGULAIR 5MG

Chewable tablets x

5mg

MONTELUKAST SODIUM x

5.2mg (FREE ACID

EQUIVALENT x 5mg) Box x 28

MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME LIMITED -

MBRETËRI E BASHKUAR

RIREGJ.

602/05.11.2010 25.43

2271 SINGULAIR 10MG

Film-coated tablets

x 10mg

MONTELUKAST SODIUM x

10.4mg (FREE ACID

EQUIVALENT x 10mg) Box x 28

MERCK SHARP &

DOHME B.V. - HOLLANDË

MERCK SHARP & DOHME

B.V. - HOLLANDË; MERCK

SHARP & DOHME LIMITED -

MBRETËRI E BASHKUAR

RIREGJ.

602/05.11.2010 24.71

2272 JANUVIA

Film Coated

Tablets x 100mg

SITAGLIPTIN (as

SITAGLIPTIN PHOSPHATE

MONOHYDRATE) Box x 28

MERCK SHARP &

DOHME LTD - MBRETERI

E BASHKUAR

MERCK SHARP & DOHME

SPA - ITALI

REGJ.

480/11.09.2009 36.02

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307

2273

TEMODALHard capsules x

100mgTEMOZOLOMIDE

Box x 1 glass

bottle x 5

SCHERING-PLOUGH

EUROPE - BELGJIKE

ORION CORPORATION -

FINLANDE, SCHERING-

PLOUGH LABO NV -

BELGJIKE

RIREGJ.

336/20.07.2012

262.5

2274

TEMODALHard capsules x

250mgTEMOZOLOMIDE

Box x 1 glass

bottle x 5

SCHERING-PLOUGH

EUROPE - BELGJIKE

ORION CORPORATION -

FINLANDE, SCHERING-

PLOUGH LABO NV -

BELGJIKE

RIREGJ.

336/20.07.2012

642.9

2275 BEN-U-RON Syrup x 200mg/5ml PARACETAMOL

Box x 1 flacon x

100ml

BENE-ARZNEIMITTEL

GMBH - GJERMANI

BENE-ARZNEIMITTEL GMBH

- GJERMANI REGJ 3/07.01.2013 1.68

2276 BEN-U-RON Tablets x 500mg PARACETAMOL Box x 20

BENE-ARZNEIMITTEL

GMBH - GJERMANI

BENE-ARZNEIMITTEL GMBH

- GJERMANI REGJ 3/07.01.2013 0.97

2277

TALVOSILEN

FORTE

Capsules x (500mg

+ 30mg)

PARACETAMOL +

CODEINE PHOSPHATE

HEMIHYDRATE Box x 20

BENE-ARZNEIMITTEL

GMBH - GJERMANI

BENE-ARZNEIMITTEL GMBH

- GJERMANI REGJ 3/07.01.2013 2.29

2278 TALVOSILEN

Tablets x (500mg +

20mg)

PARACETAMOL +

CODEINE PHOSPHATE

HEMIHYDRATE Box x 20

BENE-ARZNEIMITTEL

GMBH - GJERMANI

BENE-ARZNEIMITTEL GMBH

- GJERMANI REGJ 3/07.01.2013 1.5

2279 IB-U-RON

Suppositories x

75mg IBUPROFEN Box x 10

BENE-ARZNEIMITTEL

GMBH - GJERMANI

BENE-ARZNEIMITTEL GMBH

- GJERMANI

REGJ.

357/10.06.2009 1.34

2280 IB-U-RON

Suppositories x

150mg IBUPROFEN Box x 10

BENE-ARZNEIMITTEL

GMBH - GJERMANI

BENE-ARZNEIMITTEL GMBH

- GJERMANI

REGJ.

357/10.06.2009 1.6

2281

KLAVUNAT BID

200/28MG

Suspension x

(200mg +

28.5mg)/5ml

AMOXICILLIN +

CLAVULANIC ACID

Box x 1 glass

bottle x 70ml

ATABAY KIMYA SANAYI

VE TIC. AS - TURQI

ATABAY KIMYA SANAYI VE

TIC. AS - TURQI

REGJ.

369/17.06.2009 2.37

2282 CIPRONATIN

Film coated tablets

x 750mg CIPROFLOXACIN Box x 14

ATABAY KIMYA SAN. VE

TIC. A.S. - TURQI

ATABAY ILAC FABRIKASI

A.S. - TURQI

REGJ.

421/29.07.2009 2.96

2283 PAROL

Solution for

infusion x 10mg/ml PARACETAMOL

Box x 12 glass

vials x 100ml

(for hospital

use)

ATABAY KIMYA SANAYII

VE TICARET AS - TURQI

MEFAR ILAC SANAYII VE

TICARET AS -TURQI

REGJ

379/10.08.2012 54

2284 PAROL Tablets x 500mg PARACETAMOL Box x 30

ATABAY ILAC FABRIKASI

AS - TURQI

ATABAY ILAC FABRIKASI AS -

TURQI

REGJ.

467/04.09.2009 0.41

2285 TRIMOKS FORT

Tablets x (160mg +

800mg)

TRIMETHOPRIM +

SULPHAMETHOXAZOLE Box x 20

ATABAY KIMYA SAN. VE

TIC. A.S. - TURQI

ATABAY ILAC FABRIKASI

A.S. - TURQI

REGJ.

421/29.07.2009 2.96

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308

2286 TOTEKVIN

Solution for

injection x

1500IU/1ml

TETANUS ANTITOXIN

(IMMUNOGLOBULINE,

EQUINE) MINIMUM 1500IU

Box x 10

ampoules x 1ml

INSTITUTE OF

VIROLOGY, VACCINES

AND SERA TORLAK -

REPUBLIKA E SERBISË

INSTITUTE OF VIROLOGY,

VACCINES AND SERA

TORLAK - REPUBLIKA E

SERBISË

RIREGJ.

148/09.03.2010 9.3

2287

ATASOL FORTE

TAB 500MG

Tablets (extra

strength) x 500mg ACETAMINOPHEN Box x 30

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

632/19.11.2009 2.4

2288

ATASOL FORTE

TAB 500MG

Tablets (extra

strength) x 500mg ACETAMINOPHEN Box x 100

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

632/19.11.2009 7.4

2289

DIOVOL PLUS

TABLETS

Tablets x (25mg +

300mg + 100mg)

SIMETHICONE +

ALUMINUM HYDROXIDE-

MAGNESIUM CARBONATE-

CO DRIED GEL +

MAGNESIUM HYDROXIDE Box x 50

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

71/09.02.2010 4.2

2290

GRAVOL

FILMKOTE TAB

50MG Tablets x 50mg DIMENHYDRINATE Box x 30

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

632/19.11.2009 2.4

2291

GRAVOL LIQUID

15MG/5ML Syrup x 15mg/5ml DIMENHYDRINATE

Box x bottle x

75ml

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

71/09.02.2010 2.8

2292

ULTRA

STRENGTH OVOL Tablets x 180mg SIMETHICONE Box x 16

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

632/19.11.2009 3.3

2293

OVOL DROPS

40MG

Drops solution x

40mg/ml SIMETHICONE

Box x flacon x

15ml

CHURCH & DWIGHT

CANADA CORP.

(MISSISSAUGA) -

KANADA

CHURCH & DWIGHT

CANADA CORP.

(MONTREAL) - KANADA

RIREGJ.

672/08.12.2009 5.2

Page 308

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309

2294 ANTIVOM Tablets x 8mg

BETAHISTINE

DIHYDROCHLORIDE

(corresp. To BETAHISTINE

BASE x 5.28mg) Box x 50

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

527/23.12.2011 2.5

2295 ANTIVOM Tablets x 16mg

BETAHISTINE

DIHYDROCHLORIDE

(corresp. To BETAHISTINE

BASE x 10.56mg) Box x 50

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

527/23.12.2011 4.4

2296 TREBON - N

Powder for oral

suspension x

200mg/5ml ACETYLCYSTEINE

Box x 1 glass

bottle x 120ml

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

527/23.12.2011 2.6

2297 TREBON - N

Granules for oral

suspension x

200mg/sachet ACETYLCYSTEINE

Box x 20

sachets

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

527/23.12.2011 2.5

2298 TREBON - N

Granules for oral

suspension x

600mg/sachet ACETYLCYSTEINE

Box x 20

sachets

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

527/23.12.2011 4.5

2299 SPASMO APOTEL

Solution for

injection x (600 +

20)mg/4ml

PARACETAMOL +

HYOSCINE

BUTYLBROMIDE

Box x 3

ampoules x 4ml

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

549/31.10.2012 1.87

2300 HEMAFER FOL

Chewable tablets x

(100 + 0.35)mg

IRON (III) (as FERRIC

HYDROXIDE

POLYMALTOSE COMPLEX

x 357mg) + FOLIC ACID Box x 30

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

549/31.10.2012 2.93

2301 HEMAFER

Oral drops, solution

x 50mg/ml

IRON (III) (as FERRIC

HYDROXIDE

POLYMALTOSE COMPLEX

x 178.5mg/ml)

Box x 1 flacon x

30ml

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

549/31.10.2012 1.78

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310

2302 APOTEL

Suppositories x

500mg PARACETAMOL Box x 5

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

264/12.06.2012 1.32

2303 APOTEL

Effervescent

tablets x 500mg

PARACETAMOL (as

PARACETAMOL DCP3 x

515mg) Box x 12

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ

264/12.06.2012 1.54

2304 SALOSPIR

Gastro-resistant

tablets x 100mg ACETYLSALICYLIC ACID Box x 20

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

RIREGJ

597/26.11.2012 0.92

2305 SALOSPIR

Gastro-resistant

tablets x 325mg ACETYLSALICYLIC ACID Box x 20

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

RIREGJ

597/26.11.2012 0.84

2306 APOTEL

Solution for

intravenous

infusion x 1g/6.7ml PARACETAMOL

Box x 3

ampoules

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

REGJ.

222/08.04.2009 4.75

2307 APOTEL PLUS

Solution for I.M.

Injection x (600mg

+ 20mg)/4ml

PARACETAMOL +

LIDOCAINE

HYDROCHLORIDE

Box x 3

ampoules x 4ml

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

RIREGJ

166/19.04.2012 4.65

2308 T4 Tablets x 75mcg

LEVOTHYROXINE SODIUM

ANHYDROUS Box x 30

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

RIREGJ

597/26.11.2012 1.05

2309 T4 Tablets x 88mcg

LEVOTHYROXINE SODIUM

ANHYDROUS Box x 30

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

RIREGJ

597/26.11.2012 1.08

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311

2310 UNIMAZOLE Tablets x 5mg THIAMAZOLE Box x 60

UNI-PHARMA KLEON

TSETIS

PHARMACEUTICAL

LABORATORIES SA -

GREQI

UNI-PHARMA KLEON TSETIS

PHARMACEUTICAL

LABORATORIES SA - GREQI

RIREGJ

597/26.11.2012 1.55

2311 PROGEFFIK

Soft capsules for

oral or vaginal use

x 200mg PROGESTERONE Box x 15 EFFIK - FRANCE EFFIK - FRANCE

REGJ

307/07.05.2013 4.5

2312 FLECOXIN Tablets x 8mg

BROMHEXINE

HYDROCHLORIDE Box x 20 REMEDICA LTD - QIPRO REMEDICA LTD - QIPRO

RIREGJ.

268/28.04.2010 0.6

2313 MYCORIL

Spray solution x

1% (w/v) CLOTRIMAZOLE Box x 1 bottle REMEDICA LTD - QIPRO REMEDICA LTD - QIPRO

REGJ

208/07.05.2012 2.8

2314 REMETHAN Gel x 1% (w/w)

DICLOFENAC SODIUM (as

DICLOFENAC

DIETHYLAMINE)

Box x 1 tube x

50g REMEDICA LTD - QIPRO REMEDICA LTD - QIPRO

REGJ

208/07.05.2012 1.5

2315 REMETHAN Gel x 1% (w/w)

DICLOFENAC SODIUM (as

DICLOFENAC

DIETHYLAMINE)

Box x 1 tube x

20g REMEDICA LTD - QIPRO REMEDICA LTD - QIPRO

REGJ

208/07.05.2012 0.9

2316 IMMUNATE 250 IE

Powder and

solvent for solution

for injection x 250

IU/5ml

COAGULATION FACTOR

VIII

Box x 1 vial with

powder + 1 vial

with solvent

(water for

injection) x 5ml

+ 1 transfer/filter

set + 1 syringe

5ml + 1 winged

infusion set BAXTER AG - AUSTRI BAXTER AG - AUSTRI

REGJ.

432/29.07.2010 110

Page 311

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312

2317 IMMUNATE 500 IE

Powder and

solvent for solution

for injection x 500

IU/5ml

COAGULATION FACTOR

VIII

Box x 1 vial with

powder + 1 vial

with solvent

(water for

injection) x 5ml

+ 1 transfer/filter

set + 1 syringe

5ml + 1 winged

infusion set BAXTER AG - AUSTRI BAXTER AG - AUSTRI

REGJ.

432/29.07.2010 220

2318

HUMAN ALBUMIN

BAXTER

Solution for

Infusion x 20%

(200g/L) HUMAN ALBUMIN

Box x 1 bottle x

50ml BAXTER AG - AUSTRI BAXTER AG - AUSTRI

REGJ.

181/18.03.2009 42

2319

HUMAN ALBUMIN

BAXTER

Solution for

Infusion x 20%

(200g/L) HUMAN ALBUMIN

Box x 1 Bottle x

100ml BAXTER AG - AUSTRI BAXTER AG - AUSTRI

REGJ.

181/18.03.2009 84

2320 PARTOBULIN SDF

Solution for

Intramuscular

Injection x 1250

I.U.

HUMAN ANTI-D(Rho)

IMMUNOGLOBULIN

Box x 1

preloaded

syringe BAXTER AG - AUSTRI BAXTER AG - AUSTRI

REGJ.

181/18.03.2009 50

2321 TETABULIN S/D

Solution for

injection x 250 I.U.

HUMAN TETANUS-

ANTITOXIN

IMMUNOGLOBULIN

Box x 1 prefilled

syringe BAXTER AG - AUSTRI BAXTER AG - AUSTRI

REGJ.

180/18.03.2009 11

2322

DIANEL PD4

GLUCOSE

1.36%W/V

Solution for

peritoneal dialysis

x (13.6g + 5.38g +

4.48g + 184mg +

51mg)1L

ANHYDROUS GLUCOSE (or

GLUCOSE MONOHYDRATE

x 15g/1L) + SODIUM

CHLORIDE + SODIUM

LACTATE + CALCIUM

CHLORIDE + MAGNESIUM

CHLORIDE)

Box x 5 plastic

bag x 2000ml

(for hospital

use)

BAXTER HEALTHCARE

LTD - MBRETERI E

BASHKUAR

BAXTER HEALTHCARE SA -

IRLANDE

REGJ

45/30.01.2012 28.5

Page 312

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313

2323

DIANEL PD4

GLUCOSE

2.27%W/V

Solution for

peritoneal dialysis

x (22.7g + 5.38g +

4.48g + 184mg +

51mg)1L

ANHYDROUS GLUCOSE (or

GLUCOSE MONOHYDRATE

x 25g/1L) + SODIUM

CHLORIDE + SODIUM

LACTATE + CALCIUM

CHLORIDE + MAGNESIUM

CHLORIDE)

Box x 5 plastic

bag x 2000ml

(for hospital

use)

BAXTER HEALTHCARE

LTD - MBRETERI E

BASHKUAR

BAXTER HEALTHCARE SA -

IRLANDE

REGJ

45/30.01.2012 28.5

2324

DIANEL PD4

GLUCOSE

3.86%W/V

Solution for

peritoneal dialysis

x (38.6g + 5.38g +

4.48g + 184mg +

51mg)1L

ANHYDROUS GLUCOSE (or

GLUCOSE MONOHYDRATE

x 42.5g/1L) + SODIUM

CHLORIDE + SODIUM

LACTATE + CALCIUM

CHLORIDE + MAGNESIUM

CHLORIDE)

Box x 5 plastic

bag x 2000ml

(for hospital

use)

BAXTER HEALTHCARE

LTD - MBRETERI E

BASHKUAR

BAXTER HEALTHCARE SA -

IRLANDE

REGJ

45/30.01.2012 28.5

2325

METACOLINA

LOFARMA

Powder and

powder for solution

to nebulize x 1%

METHACOLINE CHLORIDE

x 30mg/vial

Box x 10 vial

containing

powder + 5 vial

containing

powder buffer LOFARMA SPA - ITALI

LOFARMA SPA - ITALI;

BIOLAB SPA - ITALI

RIREGJ.

268/28.04.2010 303

2326

METACOLINA

LOFARMA

Powder and

powder for solution

to nebulize x 0.2%

METHACOLINE CHLORIDE

x 6mg/vial

Box x 5 vial

containing

powder + 5 vial

containing

powder buffer LOFARMA SPA - ITALI

LOFARMA SPA - ITALI;

BIOLAB SPA - ITALI

RIREGJ.

268/28.04.2010 73.2

Page 313

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314

2327

CIRKAN A LA

PREDNACINOLON

E

Suppositories x

(0.02g + 0.0005g +

500 UI + 5000 UI +

0.01g + 0.003g)

RUSCOSIDES

(corresponding to 0.04g of

50% extract per suppository)

+ DESONIDE or

PREDNACINOLONE +

HEPARIN SODIUM SALT +

RETINOL or VIT. A

PALMITATE + LIDOCAINE

HYDROCHLORIDE +

TOCOPHEROL ACETATE or

VIT. E Box x 12

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

RIREGJ.

531/14.10.2009 2.64

2328 CYCLO 3 FORT

Hard capsules x

(150mg + 150mg +

100mg)

DRY RUSCUS EXTRACT

TITRATED IN STEROLIC

HETEROSIDES +

HESPERIDIN METHYL

CHALCONE + ASCORBIC

ACID Box x 30

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

RIREGJ.

446/03.08.2010 3.14

2329 ELUDRILPRO

Mouthwash

solution x (0.5ml +

0.5g) / 100ml

CHLORHEXIDINE

DIGLUCONATE SOLUTION

+ CHLOROBUTANOL

HEMIHYDRATE

Box x bottle x

200ml

LABORATOIRES PIERRE

FABRE MEDICAMENT -

FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE (APLIKANT:

PIERRE FABRE

MEDICAMENT - FRANCE)

RIREGJ.

339/03.06.2009 2

2330 ELUDRIL

Spray x (0.05g +

0.015g)

CHLORHEXIDINE

DIGLUCONATE +

TETRACAINE

HYDROCHLORIDE

Box x 1

pressurized

flacon x 55ml +

1 mouthpiece

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE (APLIKANT:

PIERRE FABRE

MEDICAMENT - FRANCE)

RIREGJ.

446/26.08.2009 2.05

2331 PRIMALAN

Syrup x

0.05g/100ml MEQUITAZINE

Box x 1 flacon x

60ml

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

RIREGJ.

251/23.04.2009 1.66

Page 314

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315

2332 PRIMALAN

Scored tablets x

10mg MEQUITAZINE Box x 14

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

RIREGJ.

251/23.04.2009 2.3

2333 TARDYFERON

Coated tablets x

80mg

IRON (as FERROUS

SULPHATE x 1.5 H2O x

256.3 mg ) Box x 30

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

192/19.03.2009 1.86

2334 TARDYFERON B9

Coated tablets x

(50mg + 0.35mg)

IRON (corresp. to FERROUS

SULPHATE x 1.5 H2O x

160.2mg) + FOLIC ACID

ANHYDROUS Box x 30

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

RIREGJ.

339/03.06.2009 1.9

2335 ARTHRODONT

Gingival paste x

1% ENOXOLONE

Box x 1 tube x

80g

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

432/29.07.2010 2

2336 OROPERIDYS

Oral dispersable

tablets x 10mg DOMPERIDONE Box x 30

PIERRE FABRE

FARMAKA A.E - GREQI

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE

REGJ.

596/26.11.2012 1.1

2337 STRUCTUM Capsules x 500mg

SODIUM CHONDROITIN

SULFATE Box x 60

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE (APL: PIERRE

FABRE MEDICAMENT -

FRANCE)

REGJ.

596/26.11.2012 12.5

2338 FLANID

Scored tablets x

200mg TIAPROFENIC ACID Box x 15

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE (APL: PIERRE

FABRE MEDICAMENT -

FRANCE)

REGJ.

596/26.11.2012 2.2

2339 PANSORAL

Gel for oromucosal

application x

(8.7g/100g +

0.01g/100g)

CHOLINE SALICYLATE +

CETALKONIUM CHLORIDE

Box x tube x

15g

PIERRE FABRE

MEDICAMENT - FRANCE

PIERRE FABRE

MEDICAMENT PRODUCTION

- FRANCE (APL: PIERRE

FABRE MEDICAMENT -

FRANCE)

REGJ.

596/26.11.2012 1.7

Page 315

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316

2340 INZITAN

Solution for

injection x (60mg +

0.25mg + 50mg +

4mg)/2ml

LIDOCAINE

HYDROCHLORIDE +

CYANOCOBALAMINE +

THIAMINE

HYDROCHLORIDE +

DEXAMETHASONE

Box x 6

ampoules x 2ml

KERN PHARMA SL -

SPANJE KERN PHARMA SL - SPANJE

REGJ

307/07.05.2013 7.96

2341 FENTANEST

Solution for

injection x

0.15mg/3ml

FENTANYL (as FENTANYL

CITRATE x 0.0785mg/ml)

Box x 5

ampoules x 3ml

KERN PHARMA SL -

SPANJE KERN PHARMA SL - SPANJE

REGJ

359/28.05.2013 7.8

2342 NEOCEF

Film - coated

tablets x 400mg CEFIXIME Box x 8

LABORATORIOS ATRAL

SA - PORTUGALI

LABORATORIOS ATRAL SA -

PORTUGALI (APL:

LABORATORIOS ATRAL SA -

PORTUGALI)

REGJ

452/31.10.2011 10

2343

CEFIXIMA

NEOCEF

Powder for oral

suspension x

100mg/5ml CEFIXIME

Box x 1 glass

bottle x 120ml

LABORATORIOS ATRAL

SA - PORTUGALI

LABORATORIOS ATRAL SA -

PORTUGALI (APL:

LABORATORIOS ATRAL SA -

PORTUGALI)

REGJ

452/31.10.2011 10

2344 AZACID

Film-coated tablets

x 500mg

AZITHROMYCIN

(AZITHROMYCIN

DIHYDRATE) Box x 3

NEAPHARMA S.R.L -

ITALI

DOPPEL FARMACEUTICI

S.R.L, - ITALI REGJ 3/07.01.2013 6.2

2345 GRAY

Film-coated tablets

x 500mg

LEVOFLOXACIN

(LEVOFLOXACIN

HEMIHYDRATE) Box x 5

NEAPHARMA S.R.L -

ITALI

DOPPEL FARMACEUTICI

S.R.L (ROZZANO SITE), -

ITALI; DOPPEL

FARMACEUTICI S.R.L.

(CORTEMAGGIORE SITE), -

ITALI REGJ 3/07.01.2013 9.8

2346 PRIZITEC

Oral drops, solution

x 10mg/ml

CETRIZINE

DIHYDROCHLORIDE

Box x 1 glass

bottle of 20ml

NEAPHARMA S.R.L -

ITALI

DOPPEL FARMACEUTICI

S.R.L, - ITALI REGJ 3/07.01.2013 4.8

2347 FUSINDAC Cream x 2% (w/w) FUSIDIC ACID

Box x 1 tube x

15g VIOFAR LTD - GREQI VIOFAR LTD - GREQI

REGJ.

577/28.10.2010 2.91

2348 FUSINDAC-H

Cream x (2% +

1%) w/w

FUSIDIC ACID +

HYDROCORTISONE

ACETATE

Box x 1 tube x

30g VIOFAR LTD - GREQI VIOFAR LTD - GREQI

REGJ.

577/28.10.2010 4.06

Page 316

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317

2349 ODRINOL

Rectal solution x

(20.8 + 7.8)g/130ml

SODIUM PHOSPHATE

MONOBASIC

MONOHYDRATE 160mg/1ml

+ SODIUM PHOSPHATE

DIBASIC HEPTAHYDRATE

60mg/1ml

Box x 1 plastic

bottle (enema) x

130ml VIOFAR LTD - GREQI VIOFAR LTD - GREQI

REGJ.

577/28.10.2010 1.3

2350 ORPHEDRIN

Oral solution x

50mg/5ml

ORPHENADRINE

HYDROCHLORIDE

Box x 1 glass

bottle x 200ml VIOFAR LTD - GREQI VIOFAR LTD - GREQI

REGJ

307/07.05.2013 11

2351 RADERMIN Gel x 10% (w/w) ETOFENAMATE

Box x 1 tube x

100g VIOFAR LTD - GREQI VIOFAR LTD - GREQI

REGJ.

577/28.10.2010 3.41

2352 ZYRTEC

Oral Drops x 10mg/

ml

CETIRIZINE

DIHYDROCHLORIDE

Box x flacon x

10ml

UCB PHARMA AG -

ZVICER

AESICA

PHARMACEUTICALS SRL -

ITALI

RIREGJ

423/11.07.2013 1.7

2353 XYZAL

Film coated tablets

x 5mg

LEVOCETIRIZINE

DIHYDROCHLORIDE Box x 10

UCB PHARMA AG -

ZVICER

UCB FARCHIM SA - ZVICER;

UCB PHARMA SA -

BELGJIKE

RIREGJ

423/11.07.2013 2.12

2354 XYZAL

Oral Drops x 5mg/

ml

LEVOCETIRIZINE

DIHYDROCHLORIDE

Box x flacon x

20ml

UCB PHARMA AG -

ZVICER

AESICA

PHARMACEUTICALS SRL -

ITALI

RIREGJ

423/11.07.2013 4.5

2355 BIDIEN

Cutaneous solution

x 0.025g/100g BUDESONIDE

Box x flacon x

30ml

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 3.5

2356 BIDIEN

Cream x

0.025g/100g BUDESONIDE

Box x tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 3.5

2357 BIDIEN

Ointment x

0.025g/100g BUDESONIDE

Box x tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 3.5

2358 CITRIZAN

Gel x 800.000

IU/100g CATALASE EQUINE

Box x tube x

50g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 5.2

2359

CITRIZAN

ANTIBIOTICO

Gel x (800.000

IU/100g +

0.1g/100g)

CATALASE EQUINE +

GENTAMYCINE SULPHATE

Box x tube x

50g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 6.3

2360 CISTIDIL Tablet x 500mg L-CISTEINE Box x 30

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 6.58

2361 ALOXIDIL

Cutaneous solution

x 2g/100g MINOXYDIL (dci)

Box x flacon x

60ml

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

RIREGJ

334/20.05.2013 8.86

Page 317

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318

2362 PAF

Cutaneous solution

x 50%

BISBUTYLCARBOETHYLEN

E

Box x 1 flacon x

5g LOFARMA SPA - ITALI

LOFARMA SPA - ITALI;

LABORATORIO ITALIANO

BIOCHIMICO

FARMACEUTICO

LISAPHARMA SPA - ITALI

RIREGJ

458/19.08.2013 7.6

2363 ERITROMICINA IDI Cream x 3% (w/w) ERYTHROMYCIN BASE

Box x 1 tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 6.25

2364 ERITROMICINA IDI

Cutaneous solution

x 3% (w/v) ERYTHROMYCIN BASE

Box x 1 flacon x

40ml

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 6.25

2365 GENTAMICINA IDI

Cream x 0.1%

(w/w)

GENTAMICIN (as

GENTAMICIN SULPHATE x

0.166g/100g)

Box x 1 tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 5.71

2366

GENTAMICINA E

BETAMETASONE

IDI

Cream x (0.1% +

0.1%)w/w

GENTAMICIN (as

GENTAMICIN SULPHATE x

0.166g/100g) +

BETAMETHASONE (as

BETAMETHASONE

VALERATE x 0.122g/100g)

Box x 1 tube x

30g

IDI FARMACEUTICI SRL -

ITALI

IDI FARMACEUTICI SRL -

ITALI

REGJ

298/25.06.2012 5.71

2367 SALONPAS

Plaster x (1.32 +

1.2 + 0.26 + 0.42)

mg/cm2

METHYL SALICYLATE + L-

MENTHOL + DL-CAMPHOR

+ TOCOPHEROL ACETATE

Box 1 Pouch x 2

patches (large)

x (13cm x

8.4cm) VIANEX SA - GREQI

VIANEX SA - GREQI;

HISAMITSU

PHARMACEUTICAL CO.INC -

JAPONI

RIREGJ

471/11.11.2011 2

2368 ROWATINEX

Oral drops, solution

x (24.8g + 6.2g +

15g + 3g + 4g +

10g + 4g)/100g

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

FENCHONE + BORNEOL +

ANETHOL

Box x 1 glass

dropper vial x

10ml

ROWA

PHARMACEUTICALS LTD

- IRLANDE

ROWA PHARMACEUTICALS

LTD - IRLANDE

REGJ

422/11.07.2013 5

2369 ROWACHOL

Oral drops, solution

x (13.6g + 3.4g +

5g + 2g + 6g + 32g

+ 5g)/100g

α-PINENE + β-PINENE +

CAMPHENE + CINEOL +

MENTHONE + MENTHOL +

BORNEOL

Box x 1 glass

dropper vial x

10ml

ROWA

PHARMACEUTICALS LTD

- IRLANDE

ROWA PHARMACEUTICALS

LTD - IRLANDE

REGJ

422/11.07.2013 5

Page 318

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319

2370 IMODIUM Capsules x 2mg

LOPERAMIDE

HYDROCHLORIDE Box x 20

JANSSEN-CILAG AG -

ZVICER

JANSSEN-CILAG SA -

FRANCE; JANSSEN

PHARMACEUTICA NV -

BELGJIKE (APL: CILAG AG -

ZVICER)

RIREGJ.

647/10.12.2010 3

2371

GLUCOBAY 50MG Tablets x 50mg ACARBOSE Box x 30BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

632/19.11.2009;

VARIACION MAH

dhe paketimi

687/1/09.10.2013 4.05

2372

GLUCOBAY

100MGTablets x 100mg ACARBOSE Box x 30

BAYER D.O.O -

SLLOVENI

BAYER SCHERING PHARMA

AG - GJERMANI (APL:

BAYER SCHERING PHARMA

AG - GJERMANI)

RIREGJ.

632/19.11.2009;

VARIACION MAH

dhe paketimi

687/1/09.10.2013 5.85

2373

UBISTESIN 1 / 100

000

Solution for

injection x

(40mg/ml +

10mcg/ml)

ARTICAINE

HYDROCHLORIDE +

EPINEPHRINE (as

EPINEPHRINE

HYDROCHLORIDE x

12mcg/ml)

Tin x 50

cartridges x

1.7ml (for

hospital use

only)

3M ESPE AG - GJERMANI 3M ESPE AG - GJERMANI REGJ. 74/17.02.2012

13.5

2374

SODIUM

CHLORIDE

Solution for

infusion x 0.9%SODIUM CHLORIDE

Plastified PVC

bag x 250ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

30.684

2375

SODIUM

CHLORIDE

Solution for

infusion x 0.9%SODIUM CHLORIDE

Plastified PVC

bag x 500ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

30.693

2376

SODIUM

CHLORIDE

Solution for

infusion x 0.9%SODIUM CHLORIDE

Plastified PVC

bag x 1000ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

31.136

2377

GLUCOSE 5%Solution for

infusion x 5%

GLUCOSE (AS GLUCOSE

MONOHYDRATE)

Plastified PVC

bag x 250ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

30.723

2378

GLUCOSE 5%Solution for

infusion x 5%

GLUCOSE (AS GLUCOSE

MONOHYDRATE)

Plastified PVC

bag x 500ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

30.745

Page 319

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320

2379

RINGER LACTATE

SOLUTION

Solution for

infusion x (6g/ml +

0.27g/ml + 0.4g/ml

+ 3.2g/ml)

SODIUM CHLORIDE,

CALCIUM CHLORIDE

DIHYDRATE, POTASSIUM

CHLORIDE, SODIUM

LACTATE

Plastified PVC

bag x 250ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

3

0.711

2380

RINGER LACTATE

SOLUTION

Solution for

infusion x (6g/ml +

0.27g/ml + 0.4g/ml

+ 3.2g/ml)

SODIUM CHLORIDE,

CALCIUM CHLORIDE

DIHYDRATE, POTASSIUM

CHLORIDE, SODIUM

LACTATE

Plastified PVC

bag x 500ml

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

"S.C. INFOMED FLUIDS

S.R.L." RUMANI

Riregj.458/19.08.201

3

0.742

2381

ATORVASTATIN

PHARMAS

Film-coated tablets

x 40mgATORVASTATIN Box x 30

PHARMAS D.O.O -

KROACIPHARMAS D.O.O - KROACI

REGJ.

596/26.11.2012 6

2382

BETAHISTIN

PHARMASTablets x 24mg BETAHISTINE Box x 20

PHARMAS D.O.O -

KROACIPHARMAS D.O.O - KROACI

REGJ.

596/26.11.2012 3.3

2383

PANTOPRAZOL

PHARMAS

Gastro - resistant

tablets x 20mgPANTOPRAZOLE Box x 28

PHARMAS D.O.O -

KROACIPHARMAS D.O.O - KROACI

REGJ.

140/19.03.20134.9

2384

PANTOPRAZOL

PHARMAS

Gastro - resistant

tablets x 20mgPANTOPRAZOLE Box x 56

PHARMAS D.O.O -

KROACIPHARMAS D.O.O - KROACI

REGJ.

140/19.03.20139.71

2385

PANTOPRAZOL

PHARMAS

Gastro - resistant

tablets x 40mgPANTOPRAZOLE Box x 14

PHARMAS D.O.O -

KROACIPHARMAS D.O.O - KROACI

REGJ.

140/19.03.20133.99

2386

PANTOPRAZOL

PHARMAS

Gastro - resistant

tablets x 40mgPANTOPRAZOLE Box x 28

PHARMAS D.O.O -

KROACIPHARMAS D.O.O - KROACI

REGJ.

140/19.03.20135.99

Page 320

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321

2387 OCTAGAM

Solution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (IVIG).

(1ML SOLUTION

CONTAINS: PROTEIN 50MG

OF WHICH ≥ 95% IS

HUMAN IMMUNOGLOBULIN

G, IgA ≤ 0.2MG.

DISTRIBUTION OF IgG

SUBCLASSES: IgG1 ca.

60%, IgG2 ca. 32%, IgG3 ca.

7%, IgG4 ca. 1%)

Box x 1 glass

bottle x 20ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA S.A.S. -

FRANCE; OCTAPHARMA AB -

SUEDI; OCTAPHARMA

VERTRIEB VON

PLASMADERIVATEN GMBH -

GJERMANI; OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ

61/06.02.2013 48

2388 OCTAGAM

Solution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (IVIG).

(1ML SOLUTION

CONTAINS: PROTEIN 50MG

OF WHICH ≥ 95% IS

HUMAN IMMUNOGLOBULIN

G, IgA ≤ 0.2MG.

DISTRIBUTION OF IgG

SUBCLASSES: IgG1 ca.

60%, IgG2 ca. 32%, IgG3 ca.

7%, IgG4 ca. 1%)

Box x 1 glass

bottle x 50ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA S.A.S. -

FRANCE; OCTAPHARMA AB -

SUEDI; OCTAPHARMA

VERTRIEB VON

PLASMADERIVATEN GMBH -

GJERMANI; OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ

61/06.02.2013 120

2389 OCTAGAM

Solution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (IVIG).

(1ML SOLUTION

CONTAINS: PROTEIN 50MG

OF WHICH ≥ 95% IS

HUMAN IMMUNOGLOBULIN

G, IgA ≤ 0.2MG.

DISTRIBUTION OF IgG

SUBCLASSES: IgG1 ca.

60%, IgG2 ca. 32%, IgG3 ca.

7%, IgG4 ca. 1%)

Box x 1 glass

bottle x 100ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA S.A.S. -

FRANCE; OCTAPHARMA AB -

SUEDI; OCTAPHARMA

VERTRIEB VON

PLASMADERIVATEN GMBH -

GJERMANI; OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ

61/06.02.2013 240

Page 321

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322

2390 OCTAGAM

Solution for

infusion x 50mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (IVIG).

(1ML SOLUTION

CONTAINS: PROTEIN 50MG

OF WHICH ≥ 95% IS

HUMAN IMMUNOGLOBULIN

G, IgA ≤ 0.2MG.

DISTRIBUTION OF IgG

SUBCLASSES: IgG1 ca.

60%, IgG2 ca. 32%, IgG3 ca.

7%, IgG4 ca. 1%)

Box x 1 glass

bottle x 200ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA S.A.S. -

FRANCE; OCTAPHARMA AB -

SUEDI; OCTAPHARMA

VERTRIEB VON

PLASMADERIVATEN GMBH -

GJERMANI; OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ

61/06.02.2013 480

2391

OCTAGAM

Solution for

infusion x

100mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (at least

95% IS HUMAN

IMMUNOGLOBULIN G)

Box x1 bottle x

20ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ.

307/07.05.2013

96

2392

OCTAGAM

Solution for

infusion x

100mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (at least

95% IS HUMAN

IMMUNOGLOBULIN G)

Box x1 bottle x

50ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ.

307/07.05.2013

240

2393

OCTAGAM

Solution for

infusion x

100mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (at least

95% IS HUMAN

IMMUNOGLOBULIN G)

Box x1 bottle x

100ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ.

307/07.05.2013

480

2394

OCTAGAM

Solution for

infusion x

100mg/ml

HUMAN NORMAL

IMMUNOGLOBULIN (at least

95% IS HUMAN

IMMUNOGLOBULIN G)

Box x1 bottle x

200ml

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLS

CHAFT M.B.H. - AUSTRI

OCTAPHARMA

PHARMAZEUTIKA

PRODUKTIONSGESELLSCH

AFT M.B.H. - AUSTRI

REGJ.

307/07.05.2013

960

2395

IBUPROFENO

ARGININA

CODRAMOL

Granules for oral

solution x

400mg/sachet

IBUPROFENBox x 20

sachets

"FARMALIDER SA"

SPANJE

"TOLL MANUFACTURING

SERVICES SL" SPANJE;

"LAMP S. PROSPERO SPA"

ITALI

Regj.

359/28.05.2013 3.5

Page 322

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323

2396

IBUPROFENO

ARGININA

CODRAMOL

Granules for oral

solution x

600mg/sachet

IBUPROFENBox x 40

sachets

"FARMALIDER SA"

SPANJE

"TOLL MANUFACTURING

SERVICES SL" SPANJE;

"LAMP S. PROSPERO SPA"

ITALI

Regj.

359/28.05.2013 8.8

2397

RAMIPRIL

BLUEPHARMATablets x 2.5mg RAMIPRIL Box x 60

BLUEPHARMA

GENERICOS-COMERCIO

DE MEDICAMENTOS SA -

PORTUGALI

BLUEPHARMA - INDUSTRIA

FARMACEUTICA SA -

PORTUGALI (APLIKANT PER

CERTIFIKATE:

BLUEPHARMA GENERICOS-

COMERCIO DE

MEDICAMENTOS SA -

PORTUGALI)

REGJ.

664/21.12.2010

4.8

2398

RAMIPRIL

BLUEPHARMATablets x 5mg RAMIPRIL Box x 60

BLUEPHARMA

GENERICOS-COMERCIO

DE MEDICAMENTOS SA -

PORTUGALI

BLUEPHARMA - INDUSTRIA

FARMACEUTICA SA -

PORTUGALI (APLIKANT PER

CERTIFIKATE:

BLUEPHARMA GENERICOS-

COMERCIO DE

MEDICAMENTOS SA -

PORTUGALI)

REGJ.

664/21.12.2010

7

2399

RAMIPRIL

BLUEPHARMATablets x 10mg RAMIPRIL Box x 60

BLUEPHARMA

GENERICOS-COMERCIO

DE MEDICAMENTOS SA -

PORTUGALI

BLUEPHARMA - INDUSTRIA

FARMACEUTICA SA -

PORTUGALI (APLIKANT PER

CERTIFIKATE:

BLUEPHARMA GENERICOS-

COMERCIO DE

MEDICAMENTOS SA -

PORTUGALI)

REGJ.

664/21.12.2010

10.4

2400

ALGOLIDERPowder for oral

solution x 100mgNIMESULIDE

Box x 30

sachets

"SIAR PHARMA S.R.L"

ITALI

"FINE FOODS &

PHARMACEUTICALS N.T.M.

S.P.A" ITALI

Regj.451/13.08.2013;

Nd.U.477/09.09.2013

3.8

Page 323

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324

2401

SUMAMEDFilm coated tablets

x 500mg

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE)

Box x 3PLIVA HRVATSKA d.o.o -

KROACI

PLIVA HRVATSKA d.o.o -

KROACI

RIREGJ.

532/14.10.20095

2402

LARGOPEN Tablets x 1g

AMOXICILLIN (as

AMOXICILLIN TRIHYDRATE

x 1176,471mg)

Box x 16BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQI

REGJ.

733/28.12.2009

2

2403

BENZYLPENICILLI

N POTASSIUM

Powder for solution

for injection x

1.000.000 IU/vial

BENZYLPENICILLIN (as

BENZYLPENICILLIN

POTASSIUM)

Box x 100 vials

(for hospital use

only)

S.C. ANTIBIOTICE SA -

RUMANI

S.C. ANTIBIOTICE SA -

RUMANI

REGJ.

527/23.12.2011 50

2404

AZITHROMYCIN/V

OCATE

Powder for solution

for infusion x

500mg/vial

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE x 524.1mg/vial)

Box x 1 vial

VOCATE

PHARMACEUTICALS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ.

419/12.10.2011

4.5

2405

ISOFREDILOral drops solution

x 100mg/mlAMISULPRIDE

Box x 1 glass

bottle x 60ml

VOCATE

PHARMACEUTICALS SA -

GREQI

RAFARM SA - GREQIREGJ.

213/09.05.20129.6

2406

ISOFREDILFilm-coated tablets

x 400mgAMISULPRIDE Box x 30

VOCATE

PHARMACEUTICALS SA -

GREQI

RAFARM SA - GREQIREGJ.

213/09.05.201213.5

2407

SOMARGEN

Powder and

solvent for solution

for infusion x

3mg/vial

SOMATOSTATIN (as

SOMATOSTATIN ACETATE

x 3.24mg/vial)

Box x 1 vial of

powder + 1

ampoule of

solvent x 1ml

VOCATE

PHARMACEUTICALS SA -

GREQI

ANFARM HELLAS SA -

GREQI

REGJ.

213/09.05.2012

11.5

2408

ZEFEPIME

Powder for solution

for injection x

2g/vial

CEFEPIME (as CEFEPIME

DIHYDROCHLORIDE

MONOHYDRATE x

2404mg/vial)

Box x 1 glass

vial

VOCATE

PHARMACEUTICALS SA -

GREQI

DEMO SA - GREQI REGJ. 61/06.02.2013 6.5

2409

ZOBACTAM

Powder for solution

for injection x (4 +

0.5)g/vial

PIPERACILLIN (as

PIPERACILLIN SODIUM x

4.17g/vial) + TAZOBACTAM

(as TAZOBACTAM SODIUM

x 0.54g/vial)

Box x 1 vial

VOCATE

PHARMACEUTICALS SA -

GREQI

LABORATORIO REIG JOFRE

SA TOLEDO - SPANJE;

RAFARM SA - GREQI

REGJ.

419/12.10.2011

4.3

Page 324

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325

2410

LEVOFLOXACIN/P

HARMATHEN

Solution for

infusion x

500mg/100ml

LEVOFLOXACIN (as

LEVOFLOXACIN

HEMIHYDRATE x

5.1246mg/ml)

Box x 1 glass

vial x 100ml

PHARMATHEN SA -

GREQIPHARMATHEN SA - GREQI

REGJ.

207/07.05.2012

5.78

2411THEROFLAN Tablets x 0.5mg REPAGLINIDE Box x 30

PHARMATHEN SA -

GREQIPHARMATHEN SA - GREQI

REGJ.

207/07.05.2012 1.79

2412THEROFLAN Tablets x 1mg REPAGLINIDE Box x 30

PHARMATHEN SA -

GREQIPHARMATHEN SA - GREQI

REGJ.

207/07.05.2012 2

2413THEROFLAN Tablets x 2mg REPAGLINIDE Box x 30

PHARMATHEN SA -

GREQIPHARMATHEN SA - GREQI

REGJ.

207/07.05.2012 2.2

2414

KERSTIPONHard capsules x

1.5mg

RIVASTIGMINE (as

RIVASTIGMINE

HYDROGEN TARTRATE x

2.399mg)

Box x 28PHARMATHEN HELLAS

SA - GREQI

PHARMATHEN SA - GREQI

(APL: PHARMATHEN SA -

GREQI)

REGJ.

207/07.05.2012

3.26

2415

KERSTIPONHard capsules x

3mg

RIVASTIGMINE (as

RIVASTIGMINE

HYDROGEN TARTRATE x

4.799mg)

Box x 28PHARMATHEN HELLAS

SA - GREQI

PHARMATHEN SA - GREQI

(APL: PHARMATHEN SA -

GREQI)

REGJ.

207/07.05.2012

4.46

2416

KERSTIPONHard capsules x

4.5mg

RIVASTIGMINE (as

RIVASTIGMINE

HYDROGEN TARTRATE x

7.198mg)

Box x 28PHARMATHEN HELLAS

SA - GREQI

PHARMATHEN SA - GREQI

(APL: PHARMATHEN SA -

GREQI)

REGJ.

207/07.05.2012

6.7

2417

KERSTIPONHard capsules x

6mg

RIVASTIGMINE (as

RIVASTIGMINE

HYDROGEN TARTRATE x

9.597mg)

Box x 28PHARMATHEN HELLAS

SA - GREQI

PHARMATHEN SA - GREQI

(APL: PHARMATHEN SA -

GREQI)

REGJ.

207/07.05.2012

8.17

2418

FUROSEMIDE

Solution for

injection/infusion x

20mg/2ml

FUROSEMIDEBox x 10

ampoules x 2ml

WOCKHARDT UK

LIMITED - MBRETERI E

BASHKUAR

WOCKHARDT UK LIMITED -

MBRETERI E BASHKUAR,

LABORATORIO REIG JOFRE

SA - SPANJE

REGJ.

264/12.06.2012

2.8

2419

FUROSEMIDE Tablets x 40mg FUROSEMIDE Box x 50

"WOCKHARDT UK

LIMITED" MBRETERI E

BASHKUAR

"CP PHARMACEUTICALS

LIMITED" MBRETERI E

BASHKUAR; "WOCKARDT

LIMITED" INDI

Regj.

359/28.05.2013

1.4

2420ANDOL Tablets x 100mg ACETYLSALICYLIC ACID Box x 20

PLIVA HRVATSKA D.O.O. -

KROACI

PLIVA HRVATSKA D.O.O. -

KROACIREGJ. 14/12.01.2011

0.7

Page 325

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326

2421BUSCOL

Sugar Coated

Tablets x 10 mg

HYOSCINE

BUTYLBROMIDEBox x 20

PLIVA CROATIA LTD -

KROACI

PLIVA CROATIA LTD -

KROACI

REGJ.

369/17.06.2009 1.59

2422

DINAMICOFilm-coated tablets

x 100mg

SILDENAFIL (as

SILDENAFIL CITRATE x

140.480mg)

Box x 4PLIVA HRVATSKA D.O.O -

KROACI

PLIVA HRVATSKA D.O.O -

KROACI

REGJ.

419/12.10.201119.99

2423

DINAMICOFilm-coated tablets

x 50mg

SILDENAFIL (as

SILDENAFIL CITRATE x

70.240mg)

Box x 4PLIVA HRVATSKA D.O.O -

KROACI

PLIVA HRVATSKA D.O.O -

KROACI

REGJ.

419/12.10.201115.99

2424DIUVER Tablets x 10mg TORASEMIDE Box x 20

PLIVA HRVATSKA D.O.O -

KROACI

PLIVA HRVATSKA D.O.O -

KROACI

REGJ.

419/12.10.2011 4.1

2425DIUVER Tablets x 5mg TORASEMIDE Box x 20

PLIVA HRVATSKA D.O.O -

KROACI

PLIVA HRVATSKA D.O.O -

KROACI

REGJ.

419/12.10.2011 2.65

2426

HEPTANON Tablets x 5mgMETHADONE

HYDROCHLORIDEBox x 20

PLIVA HRVATSKA D.O.O -

REPUBLIKA E KROACISE

PLIVA HRVATSKA D.O.O -

REPUBLIKA E KROACISE

RIREGJ.

260/12.06.20122.5

2427

RINOCO

Nasal spray

suspension x

50µg/dose

FLUTICASONE (as

FLUTICASONE

PROPIONATE)

Box x 1 fl x 120

doses

PLIVA HRVATSKA D.O.O -

KROACI

TEVA CZECH INDUSTRIES

SRO - REPUBLIKA CEKEREGJ. 61/06.02.2013

4.9

2428

ZIPANTOLAGastro-resistant

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM x

1.5H2O)

Box x 14 PLIVA HRVATSKA D.O.O -

KROACI

PLIVA HRVATSKA D.O.O -

KROACI

REGJ.

419/12.10.20112.6

2429

ZIPANTOLAGastro-resistant

tablets x 40mg

PANTOPRAZOLE (as

PANTOPRAZOLE SODIUM x

1.5H2O)

Box x 28 PLIVA HRVATSKA D.O.O -

KROACI

PLIVA HRVATSKA D.O.O -

KROACI

REGJ.

419/12.10.20115

2430

ZONADINFilm-coated tablets

x 5mgZOLPIDEM TARTRATE Box x 20

PLIVA HRVATSKA D.O.O -

REPUBLIKA E KROACISE

PLIVA HRVATSKA D.O.O -

REPUBLIKA E KROACISE

RIREGJ.

260/12.06.20122.08

2431

ZONADINFilm-coated tablets

x 10mgZOLPIDEM TARTRATE Box x 20

PLIVA HRVATSKA D.O.O -

REPUBLIKA E KROACISE

PLIVA HRVATSKA D.O.O -

REPUBLIKA E KROACISE

RIREGJ.

260/12.06.20122.9

2432

KLAMOKS BID

200/28mg

Powder for oral

suspension x

(2800mg/bottle +

399mg/bottle)

AMOXICILLIN (as

AMOXICILLIN TRIHYDRATE

x 3.135g/bottle) +

CLAVULANIC ACID (as

POTASSIUM

CLAVULANATE-SYLOID AL-

1 x 0.995g/bottle)

Box x 1 bottle x

70ml

BILIM ILAC SANAYII VE

TICARET AS - TURQI

BILIM ILAC SANAYII VE

TICARET AS - TURQIREGJ. 98/22.02.2010

2.5

Page 326

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327

2433 BERLIPRIL 10 Tablets x 10mg ENALAPRIL MALEATE Box x 30

"BERLIN-CHEMIE AG"

GJERMANI

"BERLIN-CHEMIE AG"

GJERMANI; "MENARINI-VON

HEYDEN GMBH" GJERMANI

Riregj.

385/ 17.06.2013

2.88

2434

DERMAZIN Cream x 10mg/g SILVER SULPHADIAZINE Box x 1 tube x

50g

LEK PHARMACEUTICALS

DD - SLLOVENI

LEK PHARMACEUTICALS DD

- SLLOVENI; SALUTAS

PHARMA GMBH - GJERMANI

REGJ.

307/07.05.2013

2.5

2435PRILENAP Tablets x 10mg ENALAPRIL MALEATE Box x 20 HEMOFARM AD - SERBI HEMOFARM AD - SERBI

RIREGJ.

167/19.04.2012 0.352

2436

IBUPROFENFilm-coated tablets

x 200mgIBUPROFEN Box x 30

REPLEKPHARM AD-

SKOPJE - REPUBLIKA E

MAQEDONISE

REPLEKPHARM AD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

297/25.06.2012

0.54

2437

PARACETAMOL +

KOFEIN

Tablets x (500mg +

65mg)

PARACETAMOL +

CAFFEINEBox x 20

REPLEKPHARM AD

SKOPJE - REPUBLIKA E

MAQEDONISE

REPLEKPHARM AD SKOPJE -

REPUBLIKA E MAQEDONISE

RIREGJ.

409/07.10.2011

1.25

2438

IBUPROFENCream x 10%

(w/w)IBUPROFEN

Box x 1 tube x

50g

REPLEKPHARM AD-

SKOPJE - REPUBLIKA E

MAQEDONISE

REPLEKPHARM AD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

186/26.04.2012

2

2439

IBUPROFEN Syrup x 100mg/5ml IBUPROFENBox x 1 glass

bottle x 100ml

REPLEKPHARM AD-

SKOPJE - REPUBLIKA E

MAQEDONISE

REPLEKPHARM AD-SKOPJE -

REPUBLIKA E MAQEDONISE

REGJ.

186/26.04.2012

1.5

2440

EPIRAMATFilm coated tablets

x 200mgTOPIRAMATE Box x 60

PLIVA HRVATSKA d.o.o -

KROACI

PLIVA HRVATSKA d.o.o -

KROACI

REGJ.

551/14.10.2008;

Nd.U.477/09.09.201367

2441

EQUORALOral solution x

100mg/mlCYCLOSPORINE

Box x 1 glass

bottle x 50ml

TEVA CZECH

INDUSTRIES SRO -

REPUBLIKA CEKE

TEVA CZECH INDUSTRIES

SRO - REPUBLIKA CEKE

REGJ.

419/12.10.2011100

2442

EQUORALSoft gelatin

capsules x 50mgCYCLOSPORINE Box x 50

TEVA CZECH

INDUSTRIES SRO -

REPUBLIKA CEKE

TEVA CZECH INDUSTRIES

SRO - REPUBLIKA CEKE

REGJ.

419/12.10.201155

2443

RINOLAN Syrup x 5mg/5ml LORATADINEBox x 1 flacon x

100ml

PLIVA HRVATSKA D.O.O. -

KROACI

PLIVA HRVATSKA D.O.O. -

KROACI

RIREGJ.

516/24.09.20101.85

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328

2444

SUMAMED FORTE

SYRUP

Powder for oral

suspension x

200mg/5ml

AZITHROMYCIN (as

AZITHROMYCIN

DIHYDRATE)

Box x 1 flacon x

15ml

PLIVA HRVATSKA d.o.o -

KROACI

PLIVA HRVATSKA d.o.o -

KROACI

RIREGJ.

532/14.10.20095

2445PARAD Tablets x 500mg

PARACETAMOL DC 90 (as

granules) Box x 60 NOVAL SHPK SHQIPERI

ARTESAN PHARMA GmbH &

KG - GJERMANIREGJ. 21/13.01.2011

145

2446

LORATADINE Syrup x 5mg/5ml LORATADINEBox x 1 glass

bottle x 150ml

PROFARMA SH.A -

SHQIPERI

PROFARMA SH.A -

SHQIPERI

REGJ.

433/29.07.2010 170

2447

FLUTINASAL

Nasal spray,

suspension x

50mcg/dose

FLUTICASONE

PROPIONATE

Box x 1 glass

bottle x 120

doses

IASIS PHARMA - GREQI IASIS PHARMA - GREQIRIREGJ.

597/26.11.20125.8

2448

AMINOPHYLLINE/

COOPER

Solution for

injection x 25mg/ml AMINOPHYLLINE

Box x 10

ampoules x

10ml COOPER SA - GREQI COOPER SA - GREQI

RIREGJ.

632/19.11.2009 2.7

2449 BETNOVATE N

Cream x (0.1% +

0.5%)

BETHAMETHASONE

VALERATE micronised (x

1.22mg/g) + NEOMYCIN

SULPHATE

Box x 1 tube x

15g

GLAXOSMITHKLINE

EXPORT LTD -

MBRETERI E BASHKUAR

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI (APL:

GLAXOSMITHKLINE

PHARMACEUTICALS SA -

POLONI)

RIREGJ

430/24.10.2011 2.09

2450

VOLTAREN 50Suppositories x

50mgDICLOFENAC SODIUM Box x 10

NOVARTIS PHARMA

SCHWEIZ AG - ZVICER

NOVARTIS PHARMA STEIN

AG - ZVICER; DELPHARM

HUNINGUE SAS - FRANCE

(APL: NOVARTIS PHARMA

AG - ZVICER)

RIREGJ.

648/25.11.2009

2.8

2451

LOSTOP Syrup x 5mg/5ml LORATADINEBox x 1 glass

bottle x 100ml

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY,

JOINT STOCK COMPANY

- BOSNJE &

HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY,

JOINT STOCK COMPANY -

BOSNJE & HERCEGOVINE

REGJ.

575/28.10.2010

1.95

2452NIDAGYL Capsules x 500mg METRONIDAZOLE Box x 24 AEGIS LTD - QIPRO AEGIS LTD - QIPRO

RIREGJ.

470/31.08.2010 4

2453

METROZOL Tablets x 500mg METRONIDAZOLE Box x 10

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL AND

CHEMICAL INDUSTRY -

BOSNJE HERCEGOVINE

RIREGJ.

435/29.07.2010

2.05

Page 328

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329

2454

ENDOXANSugar coated

tablets x 50mg

CYCLOPHOSPHAMID

ANHYDROUS (as

CYCLOPHOSPHAMID 1

H2O x 53.5mg)

Box x 50"BAXTER ONCOLOGY

GMBH" GJERMANI

"BAXTER ONCOLOGY

GMBH" GJERMANIRegj. 662/06.12.2013

9.04

2455

ENDOXAN

Dry powder for

solution for

injection x

500mg/vial

CYCLOPHOSPHAMID

ANHYDROUSBox x 1 vial

"BAXTER ONCOLOGY

GMBH" GJERMANI

"BAXTER ONCOLOGY

GMBH" GJERMANIRegj. 662/06.12.2013

7.48

2456

ENDOXAN

Dry powder for

solution for

injection x

1000mg/vial

CYCLOPHOSPHAMID

ANHYDROUSBox x 1 vial

"BAXTER ONCOLOGY

GMBH" GJERMANI

"BAXTER ONCOLOGY

GMBH" GJERMANIRegj. 662/06.12.2013

11.88

2457

HOLOXAN

Dry powder for

solution for

injection x 1g/vial

IFOSFAMIDE Box x 1 vial"'BAXTER ONCOLOGY

GMBH" GJERMANI

"'BAXTER ONCOLOGY

GMBH" GJERMANI

REGJ.

632/20.11.2013

29.54

2458

UROMITEXAN

Solucion for

injection x

400mg/4ml

MESNABox x 15

ampoules x 4ml

"'BAXTER ONCOLOGY

GMBH" GJERMANI

"'BAXTER ONCOLOGY

GMBH" GJERMANI

REGJ.

632/20.11.201319.91

2459

APONALCoated tablets x

10mg

DOXEPIN (as DOXEPIN

HYDROCHLORIDE x

11.31mg)

Box x 50

CHEPLAPHARM

ARZNEIMITTEL GMBH -

GJERMANI

DRAGENOPHARM

APOTHEKER PUSCHL GMBH

- GJERMANI

REGJ. 74/17.02.2012

5.1

2460

ZOLEDRONIC

ACID HOSPIRA

Concentrate for

solution for infusion

x 4mg/5ml

ZOLEDRONIC ACID Box x 1 vial"HOSPIRA UK LIMITED" M

BRETERI E BASHKUAR"HOSPIRA IMC" SHBA Regj. 654/03.12.2013

180

2461 LEKOKLAR

Film coated tablets

x 250mg CLARITHROMYCIN Box x 14

LEK SKOPJE DOOEL -

SKOPJE - REPUBLIKA E

MAQEDONISE

HAUPT PHARMA BERLIN

GMBH - GJERMANI

REGJ.

284/11.05.2009 4.62

2462

VIREADFilm coated tablets

x 245mg

TENOFOVIR DISOPROXIL

(eq. to 300mg TENOFOVIR

DISOPROXIL FUMARATE or

136mg TENOFOVIR)

Box x 1 plastic

bottle x 30

GILEAD SCIENCES

INTERNATIONAL

LIMITED - MBRETERI E

BASHKUAR

PATHEON INC. - KANADA,

NYCOMED ORANIENBURG

GMBH - GJERMANI, GILEAD

SCIENCES LIMITED -

IRLANDE, CATALENT

GERMANY SCHORNDORF

GMB - GJERMANI, GILEAD

SCIENCES INC - SHBA

REGJ.

530/14.10.2009

251.42

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330

2463

TRUVADA

Film coated tablets

x (200mg +

245mg)

EMTRICITABINE +

TENOFOVIR DISOPROXIL

(eq. to 300mg TENOFOVIR

DISOPROXIL FUMARATE or

136mg TENOFOVIR)

Box x 1 plastic

bottle x 30

GILEAD SCIENCES

INTERNATIONAL

LIMITED - MBRETERI E

BASHKUAR

PATHEON INC. - KANADA,

NYCOMED GMBH -

GJERMANI, GILEAD

SCIENCES LIMITED -

IRLANDE, CATALENT

GERMANY SCHORNDORF

GMB - GJERMANI, GILEAD

SCIENCES INC - SHBA

REGJ.

530/14.10.2009

352.91

2464

EVIPLERA

Film - coated

tablets s (200mg +

25mg + 245mg)

EMTRICITABINE +

RILPIVIRINE (as

HYDROCHLORIDE) +

TENOFOVIR DISOPROXIL

(as FUMARATE)

Box x 1 plastic

bottle x 30

GILEAD SCIENCES

INTERNATIONAL

LIMITED - MBRETERI E

BASHKUAR

PATHEON INC - KANADA;

GILEAD SCIENCES LIMITED -

IRLANDE; MICROCHEM

LABORATORIES IRELAND

LTD - IRELAND; GILEAD

SCIENCES INC - SHBA

REGJ. 61/06.02.2013

672.76

2465 BUSCOLYSIN

Solution for

injection x 20mg/ml

HYOSCINE

BUTYLBROMIDE

Box x 10

ampoules x 1ml

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI REGJ. 21/13.01.2011 7.9

2466

TEMPALGINFilm-coated tablets

x (500mg + 20mg)

METAMIZOLE SODIUM +

TRIACETONAMINE-4-

TOLUENSULFONATE

Box x 20SOPHARMA PLC -

BULLGARISOPHARMA PLC - BULLGARI

RIREGJ.

291/06.05.20101.943

2467

METHYLPREDNIS

OLONE

SOPHARMA

Powder and

solvent for solution

for injection x

250mg/ampoule

METHYLPREDNISOLONE

(as

METHYLPREDNISOLONE

SODIUM SUCCINATE x

331.48mg)

Box x 5

ampoules + 5

ampoules -

water for

injection x 5ml

SOPHARMA PLC -

BULLGARISOPHARMA PLC - BULLGARI

REGJ.

212/25.05.2011

29.995

2468

PARACETAMOL

SOPHARMASyrup x 120mg/5ml PARACETAMOL

Box x 1 glass

bottle x 125ml

SOPHARMA PLC -

BULLGARISOPHARMA PLC - BULLGARI REGJ. 21/13.01.2011

1.8

2469 DEFLAMOL

Ointment x (350 +

400) IU/g

RETINOL PALMITATE +

ERGOCALCIFEROL

Box x 1 tube x

18g

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI REGJ. 21/13.01.2011 2.485

2470

BROMHEXINE

SOPHARMA Syrup x 4mg/5ml

BROMHEXINE

HYDROCHLORIDE

Box x 1 glass

bottle x 125ml

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI REGJ. 21/13.01.2011 2.5

2471

EPHEDRINE

SOPHARMA

Solution for

injection x 50mg/ml

EPHEDRINE

HYDROCHLORIDE

Box x 10

ampoules x 1ml

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

REGJ

207/07.05.2012 6.37

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331

2472 BRONCHOLYTIN

Syrup x (4.6mg +

5.75mg)/5ml

EPHEDRINE

HYDROCHLORIDE +

GLAUCINE

HYDROBROMIDE

Box x bottle x

125g

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

RIREGJ.

291/06.05.2010 2.223

2473 TABEX

Film-coated tablets

x 1.5mg CYTISINE

Box x 100 (for

hospital use

only)

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

REGJ

208/07.05.2012 12.16

2474 TRIBESTAN

Film-coated tablets

x 250mg

TRIBULUS TERRESTRIS

HERBA EXTRACTUM

SICCUM (35-45:1) (content

of FUROSTANOL

SAPONINS not less than

112.5mg) Box x 60

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

REGJ

208/07.05.2012 17.85

2475

SALBUTAMOL

SOPHARMA Syrup x 2mg/5ml

SALBUTAMOL (as

SALBUTAMOL SULPHATE)

Box x 1 glass

bottle x 125ml

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

REGJ

422/12.09.2012 1.4

2476

RANITIDIN

SOPHARMA

Film-coated tablets

x 150mg

RANITIDINE (eq. to 168mg

RANITIDINE

HYDROCHLORIDE) Box x 20

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

REGJ

422/12.09.2012 1.55

2477

AMIKACIN

SOPHARMA

Solution for

injection/infusion x

1g/4ml

AMIKACIN (as AMIKACIN

SULPHATE)

Box x 10

ampoules x 4ml

SOPHARMA PLC -

BULLGARI SOPHARMA PLC - BULLGARI

REGJ

422/12.09.2012 22

2478 MERONEM

Powder for solution

for IV injection x

500mg/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 570mg)

Box x 10 vials

(for hospital

use)

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR;

DAINIPPON SUMITOMO

PHARMACEUTICALS

COMPANY LTD - JAPONI;

ACS DOBFAR SPA - ITALI;

ZAMBON SWITZERLAND

LTD - ZVICER; CORDEN

PHARMA - ITALI

REGJ.

140/15.04.2011 140

Page 331

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332

2479 MERONEM

Powder for solution

for IV injection x

1g/vial

MEROPENEM (as

MEROPENEM

TRIHYDRATE x 1140mg)

Box x 10 vials

(for hospital

use)

ASTRAZENECA UK

LIMITED - MBRETERI E

BASHKUAR

ASTRAZENECA UK LIMITED -

MBRETERI E BASHKUAR;

DAINIPPON SUMITOMO

PHARMACEUTICALS

COMPANY LTD - JAPONI;

ACS DOBFAR SPA - ITALI;

ZAMBON SWITZERLAND

LTD - ZVICER; CORDEN

PHARMA - ITALI

REGJ.

140/15.04.2011 255

2480

NEXIUM

Powder for solution

for

injection/infusion x

40mg/vial

ESOMEPRAZOLE (as

ESOMEPRAZOLE SODIUM

x 42.5mg/vial)

Box x 10 vials

(for hospital

use)

ASTRAZENECA AB -

SUEDIASTRAZENECA AB - SUEDI

RIREGJ.

48/30.01.2012

47.83

2481 NEXIUM

Gastro-resistant

tablets x 20mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM TRIHYDRATE

x 22.3mg) Box x 14

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI;

ASTRAZENECA UK LTD -

MBRETERI E BASHKUAR;

(APL: ASTRAZENECA R&D

MOLNDAL - SUEDI)

RIREGJ

48/30.01.2012 4.29

2482 NEXIUM

Gastro-resistant

tablets x 20mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM TRIHYDRATE

x 22.3mg) Box x 28

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI;

ASTRAZENECA UK LTD -

MBRETERI E BASHKUAR;

(APL: ASTRAZENECA R&D

MOLNDAL - SUEDI)

RIREGJ

48/30.01.2012 7.37

2483 NEXIUM

Gastro-resistant

tablets x 40mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM TRIHYDRATE

x 44.5mg) Box x 14

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI;

ASTRAZENECA UK LTD -

MBRETERI E BASHKUAR;

(APL: ASTRAZENECA R&D

MOLNDAL - SUEDI)

RIREGJ

48/30.01.2012 12.46

2484 NEXIUM

Gastro-resistant

tablets x 40mg

ESOMEPRAZOLE (as

ESOMEPRAZOLE

MAGNESIUM TRIHYDRATE

x 44.5mg) Box x 28

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI;

ASTRAZENECA UK LTD -

MBRETERI E BASHKUAR;

(APL: ASTRAZENECA R&D

MOLNDAL - SUEDI)

RIREGJ

48/30.01.2012 22.3

Page 332

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333

2485

PLENDILProlonged-release

tablets x 2.5mgFELODIPINE Box x 30

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI,

ASTRAZENECA

PHARMACEUTICAL CO LTD -

KINE

RIREGJ.

633/20.11.2013

5.97

2486

PULMICORT

TURBUHALER

Inhalation powder x

400mcg/dose BUDESONIDE

Box x 1

turbuhaler x 100

doses

"ASRTAZENECA AB" -

SUEDI

"ASRTAZENECA AB" - SUEDI

DHE ME APLIKANT PER

CERTIFIKATE

"ASTRAZENECA R&D LUND" -

SUEDI

RIREGJ

372/27.09.2011 17.99

2487 PULMICORT

Nebuliser

suspension x

0.5mg/ml BUDESONIDE

Box x 20 single

dose-unit x 2ml

ASTRAZENECA AB -

SUEDI

ASTRAZENECA AB - SUEDI

(APL: ASTRAZENECA -

MBRETERI E BASHKUAR)

REGJ.

140/15.04.2011 15.2

2488

ASIST Capsules x 200mg ACETYLCYSTEINE Box x 30HUSNU ARSAN ILACLARI

A.S. - TURQI

BILIM ILAC SANAYII VE

TICARET A.S. - TURQI

RIREGJ. 433/2 Dt.

28.09.20123.5

2489

ARAVAFilm coated tablet x

10mgLEFLUNOMIDE

Box x 1 bottle x

30

SANOFI - AVENTIS

DEUTSCHLAND GMBH -

GJERMANI

SANOFI-WINTHROP

INDUSTRIE - FRANCE

RIREGJ.

633/20.11.201324.93

2490

PLAVIXFilm coated tablets

x 300mg

CLOPIDOGREL (AS

CLOPIDOGREL

HYDROGEN SULPHATE)

Box x 4

SANOFI PHARMA

BRISTOL-MYERS

SQUIBB SNC - FRANCE

SANOFI WINTHROP

INDUSTRIE - FRANCE (APL:

SANOFI-AVENTIS R & D -

FRANCE)

REGJ.

192/19.03.2009

13

2491

TARKA

Modified-release

tablets x (240mg +

4mg)

VERAPAMIL

HYDROCHLORIDE +

TRANDOLAPRIL

Box x 28"ABBOTT GMBH &

CO.KG" GJERMANI

"ABBOTT GMBH & CO.KG"

GJERMANI dhe me aplikant

per çertifikate "ABBOTT

GMBH & CO.KG" GJERMANI

Regj. 662/06.12.2013

14

2492

TRIAPIN

Film coated

tablets x (2.5mg

+ 2.5mg)

RAMIPRIL +

FELODIPINEBox x 14

SANOFI - AVENTIS

DEUTSCHLAND

GMBH - GJERMANI

ASTRAZENECA AB -

SUEDI,

PHARMACEUTICAL

AND CHEMICAL

WORKS PRIVATE CO.

LTD. - HUNGARI

REGJ.

284/11.05.2009

1.75

2493ZENARO

Film - coated

tablets x 5mg

LEVOCETIRIZINE

DIHYDROCHLORIDEBox 20

ZENTIVA K.S -

REPUBLIKA CEKE

ZENTIVA K.S -

REPUBLIKA CEKE

REGJ.

307/07.05.2013 3.85

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334

2494

SEVORANEInhalation liquid

x 100% v/vSEVOFLURANE

Box x 1 bottle

x 250ml

ABBOTT

LABORATORIES

LIMITED - MBRETERI

E BASHKUAR

ABBOTT

LABORATORIES

LIMITED - MBRETERI E

BASHKUAR; AESICA

QUEENBOROUGH

LIMITED - MBRETERI E

BASHKUAR

RIREGJ.

161/19.03.2010;

ndryshime u.m.

227/01.06.2011

160

2495

CLEXANE

Solution for

injection x 4000

IU anti-Xa/0.4ml

ENOXAPARIN SODIUM

(EQUIVALENT TO

40MG)

Box x 10 pre-

filled syringes

x 0.4ml

SANOFI-AVENTIS

FRANCE - FRANCE

SANOFI-WINTHROP

INDUSTRIE - FRANCE;

CHINOIN

PHARMACEUTICAL

AND CHEMICAL

WORKS PRIVATE

CO/LTD - HUNGARI

RIREGJ.

392/01.07.2009

35

2496

ACENOKUMA

ROLTablets x 4mg ACENOCOUMAROL Box x 20

"REPLEKPHARM AD-

SKOPJE" REPUBLIKA

E MAQEDONISE

"REPLEKPHARM AD-

SKOPJE" REPUBLIKA E

MAQEDONISE

Regj.

662/06.12.2013

1.1

2497

OMEPRAZOL

Gastro-resistant

hard capsules x

20mg

OMEPRAZOL Box x 14

"REPLEK FARM LTD-

SKOPJE" REPUBLIKA

E MAQEDONISE

"REPLEK FARM LTD-

SKOPJE" REPUBLIKA E

MAQEDONISE;

"RAFARM SA" GREQI

Regj.

662/06.12.2013

0.79

2498

NIFEDIPIN

RETARD

Prolonged-

release film

coated tablets x

20mg

NIFEDIPINE Box x 20

"REPLEK FARM LTD-

SKOPJE" REPUBLIKA

E MAQEDONISE

"REPLEK FARM LTD-

SKOPJE" REPUBLIKA E

MAQEDONISE;

"RAFARM SA" GREQI

Regj.

662/06.12.2013

0.5

2499

POLYGYNAX

Vaginal capsules

x (35 000 IU +

35 000 IU + 100

000 IU)

NEOMYCIN SULPHATE

+ POLYMYXIN B

SULPHATE +

NYSTATIN

Box x 6

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

333/29.08.2011

3.65

2500

POLYGYNAX

Vaginal capsules

x (35 000 IU +

35 000 IU + 100

000 IU)

NEOMYCIN SULPHATE

+ POLYMYXIN B

SULPHATE +

NYSTATIN

Box x 12

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

333/29.08.2011

7.3

2501

HELMINTOX Oral suspension

x 125mg/5ml

PYRANTEL (as

PYRANTEL

EMBONATE x

14.420g/100ml)

Box x glass

bottle x 15ml

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

109/01.03.2013

2.44

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335

2502

HELMINTOX

Scored film-

coated tablets x

125mg

PYRANTEL

EMBONATE x 360.5MG

CORRESPONDING TO

PYRANTEL BASE x

125MG

Box x 6

scored film-

coated tablets

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

409/07.10.2011

1.45

2503

HELMINTOX

Scored film-

coated tablets x

250mg

PYRANTEL

EMBONATE x 721MG

CORRESPONDING TO

PYRANTEL BASE x

250MG

Box x 3

scored film-

coated tablets

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

409/07.10.2011

1.45

2504

ATRICAN

Gastro-resistant

soft capsules x

250mg

TENONITROZOLE Box x 8

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

75/17.02.2012

3.4

2505

FLUDITEC Syrup x 20mg/ml CARBOCISTEINEBox x 1 bottle

x 125ml

"LABORATOIRE

INNOTECH

INTERNATIONAL"

FRANCE

"INNOTHERA CHOUZY"

FRANCE, dhe me aplikant

per çertifikate

"LABORATOIRE

INNOTECH

INTERNATIONAL"

BULLGARI

Regj.422/11.07.201

3; Revokuar

U.17/14.01.2014

3.1

2506

FLUDITEC Syrup x 50mg/ml CARBOCISTEINEBox x 1 bottle

x 125ml

"LABORATOIRE

INNOTECH

INTERNATIONAL"

FRANCE

"INNOTHERA CHOUZY"

FRANCE, dhe me aplikant

per çertifikate

"LABORATOIRE

INNOTECH

INTERNATIONAL"

BULLGARI

Regj.422/11.07.201

3; Revokuar

U.17/14.01.2014

3.3

2507

FLUDITEC,

DRY COUGH,

ADULTS

Drinkable

solution in bottle

x 0.15%

DEXTROMETHORPHA

N HYDROBROMIDE

Box x bottle x

150ml

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

672/08.12.2009

4.1

2508

IDEOS

Chewable tablets

x (500mg + 400

IU)

CALCIUM ELEMENT

(as CALCIUM

CARBONATE x 1250mg)

+ CHOLECALCIFEROL

(VITAMIN D3)

Box x 30

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

266/12.06.2012

4.75

Page 335

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336

2509

TOT'HEMA

Oral solution x

(50mg + 1.33mg

+ 0.7mg)/10ml

IRON (AS FERROUS

GLUCONATE) +

MANGANESE (AS

MANGANESE

GLUCONATE +

COPPER (AS COPPER

GLUCONATE)

Box x 20

ampoules x

10ml

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

409/07.10.2011

4.4

2510

PHLEBODIAFilm coated

tablets x 600mgDIOSMIN Box x 30

LABORATOIRES

INNOTHERA -

FRANCE

INNOTHERA CHOUZY -

FRANCE (APL:

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE)

RIREGJ.

149/04.03.2009

9.2

2511

SYMPATHYL

Film coated

tablets x (20mg +

75mg +

125.35mg)

ESCHSCHOLTZIA (dry

aqueous extract +

HAWTHORN BLOSSOM

(dry aqueous - alcoholic

of the flowering head) +

HEAVY MAGNESIUM

OXIDE (equivalent to

75mg elemental

magnesium i.e. 6.2mEq)

Box x 40

LABORATOIRE

INNOTECH

INTERNATIONAL -

FRANCE

INNOTHERA CHOUZY -

FRANCE

RIREGJ.

109/01.03.2013

2.9

2512

SELEMYCIN

Solution for

injection x

500mg/2ml

AMIKACIN (as

AMIKACIN SULPHATE)

Box x 10 vials

(for hospital

use only)

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

REGJ.

213/09.05.2012

6.76

2513

MEDOCLAV

1.2g

Powder for

solution for

injection/infusion

x (1000mg +

200mg)/vial

AMOXICILLIN +

CLAVULANIC ACID

Box x 10 vials

(for hospital

use)

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

REGJ.

186/26.04.2012

22

2514

ZEPILEN

Powder for

injection x

1g/vial

CEFAZOLIN (as

STERILE CEFAZOLIN

SODIUM)

Box x 10 vialsMEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRORiregj.468/03.09.

2013; Revokuar

U.700/30.12.2013 7.5

2515

MEDOCEF

Powder for

solution for

injection x

1g/vial

CEFOPERAZONE (AS

CEFOPERAZONE

SODIUM)

Box x 10 vialsMEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

REGJ.

181/18.03.2009

20.62

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337

2516

AXETINE

Powder for

solution for

injection x

750mg

CEFUROXIME (as

STERILE CEFUROXIME

SODIUM)

Box x 10 vialsMEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

REGJ.

222/08.04.2009

11.93

2517MEDOPHENIC

OL 250

Capsules x

250mgCHLORAMPHENICOL Box x 10

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

268/28.04.2010 0.3

2518RUPAN

Film-coated

tablets x 200mgIBUPROFEN Box x 30

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

47/30.01.2012 0.75

2519 MELOX Tablets x 7.5mg MELOXICAM Box x 10MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

435/29.07.2010 2.5

2520 MELOX Tablets x 15mg MELOXICAM Box x 10MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

435/29.07.2010 3.5

2521 APONIL Tablets x 100mg NIMESULIDE Box x 20MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

REGJ.

45/30.01.2012 0.7

2522 ARFEN Tablets x 500mg PARACETAMOL Box x 20MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

291/06.05.2010 0.5

2523 ARKETISFilm coated

tablets x 20mg

PAROXETINE

HYDROCHLORIDEBox x 30

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

455/06.08.2010 9.8

2524ARNETIN

Solution for

injection x

50mg/2ml

RANITIDINE (as

RANITIDINE

HYDROCHLORIDE)

Box x 5

ampoules x

2ml

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

REGJ.

208/07.05.2012 1.3

2525MEDOCYCLIN

E

Capsules x

250mg

TETRACYCLINE

HYDROCHLORIDEBox x 30

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

RIREGJ.

48/30.01.2012 0.56

2526

ENTEROFURY

L

Hard capsules x

100mgNIFUROXAZIDE Box x 30

BOSNALIJEK,

PHARMACEUTICAL

& CHEMICAL

INDUSTRY- BOSNJE

HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

Riregj.01/07.01.20

14

2.2

2527

ENTEROFURY

L

Oral suspension

x 200mg/5mlNIFUROXAZIDE

Box x 1 glass

bottle x 90ml

BOSNALIJEK,

PHARMACEUTICAL

& CHEMICAL

INDUSTRY- BOSNJE

HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

Riregj.01/07.01.20

14

2.8

2528

LOPRIL Tablets x 10mg

LISINOPRIL (as

LISINOPRIL

DIHYDRATE x

10.888mg)

Box x 20

BOSNALIJEK,

PHARMACEUTICAL

& CHEMICAL

INDUSTRY- BOSNJE

HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

Riregj.01/07.01.20

14

1.47

Page 337

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338

2529

LOPRIL Tablets x 20mg

LISINOPRIL (as

LISINOPRIL

DIHYDRATE x

21.776mg)

Box x 20

BOSNALIJEK,

PHARMACEUTICAL

& CHEMICAL

INDUSTRY- BOSNJE

HERCEGOVINE

BOSNALIJEK,

PHARMACEUTICAL &

CHEMICAL INDUSTRY-

BOSNJE HERCEGOVINE

Riregj.01/07.01.20

14

2

2530 ARFENSuppositories x

125mg PARACETAMOL Box x 10

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

Riregj.01/07.01.20

14 0.73

2531 ARFENSuppositories x

250mg PARACETAMOL Box x 10

MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

Riregj.01/07.01.20

14 0.9

2532 MEDOVIR Tablet x 800mg ACICLOVIR Box x 10MEDOCHEMIE LTD -

QIPRO

MEDOCHEMIE LTD -

QIPRO

Riregj.01/07.01.20

14 5

2533

DORMICUMFilm coated

tablets x 7.5mg

MIDAZOLAM (as

MIDAZOLAM

MALEATE)

Box x 10

ROCHE PHARMA

(SCHWEIZ) LTD -

ZVICER

PRODUCTOS ROCHE SA

de C.V - MEKSIKË

(APLIKANT:

F.HOFFMANN-LA

ROCHE LTD - ZVICER)

Riregj.01/07.01.20

14

1.4

2534

DORMICUM

Solution for

injection x

15mg/3ml

MIDAZOLAM

Box x 5

ampoules x

3ml

ROCHE PHARMA

(SCHWEIZ) LTD -

ZVICER

CENEXI SAS - FRANCE,

(APLIKANT:

F.HOFFMANN-LA

ROCHE LTD - ZVICER)

Riregj.01/07.01.20

14

5.98

2535

ESPUMISAN

EMULSION

Oral emulsion x

40mg/1ml SIMETICONE

Box x 1 glass

bottle x 30ml

BERLIN-CHEMIE AG -

GJERMANI

BERLIN-CHEMIE AG -

GJERMANI

REGJ.

448/26.08.2009 3.66

2536 ANTIFUNGOL

Cream x 10 mg

/ g CLOTRIMAZOLE

Box x 1 tube

x 50 g

"LEK SKOPJE

DOOEL-SKOPJE"

MAQEDONI

SALUTAS PHARMA

BARLEBEN -

GJERMANI; SALUTAS

PHARMA GMBH

OSTERWEDDINGEN -

GJERMANI

Riregj.01/07.01.20

14

2.3

2537 CITERAL

Concentrate for

solution for

injection x

100mg/10ml

CIPROFLOXACIN (AS

CIPROFLOXACIN

LACTATE

MONOHYDRATE)

Box x 5

ampoules x

10ml

ALKALOID AD-

SKOPJE -

MAQEDONI

ALKALOID AD-SKOPJE -

MAQEDONI; (APL:

ALKALOID AD-SKOPJE -

MAQEDONI)

RIREGJ

423/11.07.2013 4.5

2538 DIALOSA Tablets x 1 mg GLIMEPIRIDE Box x 30

SPECIFAR SA -

GREQI SPECIFAR SA - GREQIRiregj.01/07.01.20

14 3

2539 DIALOSA Tablets x 2 mg GLIMEPIRIDE Box x 30

SPECIFAR SA -

GREQI SPECIFAR SA - GREQIRiregj.01/07.01.20

14 5

2540 DIALOSA Tablets x 3 mg GLIMEPIRIDE Box x 30

SPECIFAR SA -

GREQI SPECIFAR SA - GREQIRiregj.01/07.01.20

14 7

2541 DIALOSA Tablets x 4 mg GLIMEPIRIDE Box x 30

SPECIFAR SA -

GREQI SPECIFAR SA - GREQIRiregj.01/07.01.20

14 8

Page 338

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339

2542 DIALOSA Tablets x 6 mg GLIMEPIRIDE Box x 30

SPECIFAR SA -

GREQI SPECIFAR SA - GREQIRiregj.01/07.01.20

14 10

2543

SOLU-MEDROL

Powder and

solvent for

solution for

injection-vial +

vial x 500mg

METHYLPREDNISOLO

N NATRIUM

SUCCINATE converted

from

METHYLPREDNISOLO

N HEMISUCCINATE

corresponding to

METHYLPREDNISOLO

N x 500mg

Box x (1 vial

powder + 1

vial solvent x

7.8ml)

PFIZER SA -

BELGJIKE

PFIZER

MANUFACTURING

BELGIUM NV -

BELGJIKE

(APLIKANT:PFIZER

MANUFACTURING

BELGIUM NV -

BELGJIKE)

RIREGJ.

663/06.12.2013

8

2544

SOLU-MEDROL

Solution for

injection - Act-O-

Vial x 40mg

METHYLPREDNISOLO

N NATRIUM

SUCCINATE converted

from

METHYLPREDNISOLO

N HEMISUCCINATE

corresponding to

METHYLPREDNISOLO

N X 40mg

Box x 1ml Act-

O-Vial

PFIZER SA -

BELGJIKE

PFIZER

MANUFACTURING

BELGIUM NV -

BELGJIKE

(APLIKANT:PFIZER

MANUFACTURING

BELGIUM NV -

BELGJIKE)

RIREGJ.

663/06.12.2013

1.44

2545

UMAN ALBUMIN

Solucion for

infusion x

200g/liter

SOLUTION OF

PLASMATIC PROTEINS

CONTAINING AT

LEAST 95% HUMAN

ALBUMIN

Box x 1 flacon

x 50mlKEDRION SPA - ITALI KEDRION SPA - ITALI

Riregj.

385/ 17.06.2013

30

2547

RECORMON

Solution for

injection x 10

000 IU/prefilled

syringe

EPOETIN BETA

Box x 6

prefilled

syringes x

0.6ml + 6

needles 27 Ga

1 / 2

ROCHE

REGISTRATION LTD -

MBRETERIA E

BASHKUAR

ROCHE DIAGNOSTICS

GMBH - GJERMANI;

F.HOFFMANN-LA

ROCHE LTD - ZVICER;

VETTER PHARMA-

FERTIGUNG GMBH &

CO.KG - GJERMANI

RIREGJ.

663/06.12.2013

380

Page 339

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340

2548

ROCEPHIN

Powder for

solution for I.M

injection x

1g/vial

CEFTRIAXONE (AS

CEFTRIAXONE

DISODIUM)

Box x (1 vial

with powder +

1 ampoule

with solvent

[Lidocaine

hydrochloride)

x 3.5ml]

ROCHE PHARMA

(SCHWEIZ) LTD -

ZVICER

F.HOFFMANN-LA

ROCHE LTD - ZVICER;

CENEXI S.A.S. - FRANCE

(APLIKANT:

F.HOFFMANN-LA

ROCHE LTD - ZVICER)

Riregj.01/07.01.20

14

4.69

2549

ENGERIX B

JUNIOR

Suspension for

injection x

10µg/0.5ml

HEPATITIS B SURFACE

ANTIGEN (ADSORBED

ON ALUMINIUM

HYDROXIDE,

HYDRATED)

Box x 1 pre-

filled syringe

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

Riregj.01/07.01.20

14

6.05

2550

ENGERIX B

Suspension for

injection x

20µg/1ml

HEPATITIS B SURFACE

ANTIGEN (ADSORBED

ON ALUMINIUM

HYDROXIDE,

HYDRATED)

Box x 1 pre-

filled syringe

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

GLAXOSMITHKLINE

BIOLOGICALS S.A. -

BELGJIKE

Riregj.01/07.01.20

14

7.2

2551ERITROMICINA IDI Gel x 3% (w/w) ERYTHROMYCIN

Box x tube x

30g

IDI FARMACEUTICI

SRL - ITALI

IDI FARMACEUTICI SRL

- ITALI

RIREGJ.

334/20.05.2013 6.25

2552

ENEMA COOPER

Solution x

(60mg/ml +

160mg/ml)

SODIUM PHOSPHATE

DIBASIC

HEPTAHYDRATE +

SODIUM PHOSPHATE

MONOBASIC

MONOHYDRATE

Box x 1

plastic bottle

(enema) x

125ml

COOPER SA - GREQI COOPER SA - GREQIRIREGJ.

578/02.11.2009

1.43

2554

ALFASIDFilm coated tablets

x 750mg

SULTAMICILLIN

(SULTAMICILLIN

TOSYLATE DEHYDRATE)

Box x 10ACTAVIS ILACLARI AS -

TURQI

BILIM ILAC SAN.VE TIC. AS -

TURQI

Riregj.423/11.07.201

3

9

2555 ANTIFUNGOL Cream x 10 mg / g CLOTRIMAZOLE

Box x 1 tube x

50 g

"LEK SKOPJE DOOEL-

SKOPJE" MAQEDONI

SALUTAS PHARMA

BARLEBEN - GJERMANI;

SALUTAS PHARMA GMBH

OSTERWEDDINGEN -

GJERMANI

Riregj.01/07.01.2014

2.3

Lista mbyllet me nr. Rendor 2555

Page 340