lista me cmimet e barnave jo te rimbursueshme 2014 , 17feb2014
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Lista e BarnaveTRANSCRIPT
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 26
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 64
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
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
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
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
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
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
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
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
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
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
Page 74
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
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
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
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
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
Page 79
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
Page 80
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
Page 81
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
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
Page 83
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
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
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
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
Page 87
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 139
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
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
Page 141
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
Page 142
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
Page 143
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
Page 144
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
Page 145
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 173
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
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
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
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
Page 177
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
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
Page 179
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
Page 180
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
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
Page 182
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
Page 183
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
Page 184
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
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
Page 186
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 270
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
Page 271
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
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
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
Page 274
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 294
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
Page 295
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
Page 296
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
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
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
Page 299
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
Page 300
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
Page 301
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
Page 302
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
Page 303
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
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
Page 305
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
Page 306
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
Page 307
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
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
Page 309
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
Page 310
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Page 327
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
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
Page 329
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
Page 330
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
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
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
Page 333
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
Page 334
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
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
Page 336
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
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
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
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