viðauki i listi yfir heiti, lyfjaform, styrkleika lyfjanna ......lodshusvej 11 4230 skaelskoer...

1

Viðauki I

Listi yfir heiti, lyfjaform, styrkleika lyfjanna, íkomuleiðir og markaðsleyfishafa í aðildarlöndunum

2

Aðildarríki

(í EES)

Markaðsleyfishafi INN Sérheiti Styrkleiki Lyfjaform Íkomuleið

Austurríki Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark

Járnbundið (III) hýdroxíð-dextran-samstæða

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50mg/ml Stungulyf/innrennslislyf, lausn

Til notkunar í bláæð til notkunar í vöðva

Austurríki VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France

Járnbundinn karboxýmaltsykur

Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


Til notkunar í bláæð

Austurríki Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany

Járnblönduð súkrosa-samstæða

FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Austurríki Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Austurríki Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark

Járnblandað (III) ísómaltósíð-samstæða

Monofer 100 mg/ml Injektions- oder Infusionslösung



Austurríki VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France


Venofer 20 mg/ml - Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung



3

Aðildarríki

(í EES)


Belgía Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Cosmofer 50mg/ml Stungulyf/innrennslislyf, lausn


Belgía Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Monover 100mg/ml Stungulyf/innrennslislyf, lausn


Belgía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Venofer 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Belgía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Injectafer 50,00 mg/ml

Stungulyf/innrennslislyf, lausn


Búlgaría VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Ferinject 50mg/ml Stungulyf/innrennslislyf, lausn


Búlgaría Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia Bulgaria


Idafer 20mg/ml Stungulyf, lausn Til notkunar í bláæð

4

Aðildarríki

(í EES)


Búlgaría Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Cosmofer 50mg/ml Stungulyf, lausn Til notkunar í bláæð

Búlgaría Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Monofer 100mg/ml Stungulyf/innrennslislyf, lausn


Kýpur VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML



Kýpur Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


MONOFER SOLUTION FOR INJECTION OR INFUSION 100MG/ML



Kýpur Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


COSMOFER SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML



Kýpur The Star Medicines Importers & co ltd, 9A Loukis Akritas Street, P.O.box 50151, 3601 Lemesos, Cyprus


VENOFER INJECTION 100MG IRON/5ML

100mg/5ml Stungulyf, lausn Til notkunar í bláæð

5

Aðildarríki

(í EES)


Kýpur Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML



Tékkland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


VENOFER 20mg/ml Stungulyf, lausn Til notkunar í bláæð

Tékkland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


FERROLOGIC 20 MG/ML 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Tékkland PHARMABIDE LTD 20, Lakonias str, 15234 Halandri Athens - Greece


IRON SUCROSE PHARMABIDE 20 MG/ML



Tékkland Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland


FERION 20 MG/ML 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Tékkland Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Praha 6 Czech Republic

sódíum járnbundin glókónat-samstæða

FERRLECIT 12,5mg/ml Stungulyf, lausn Til notkunar í bláæð

6

Aðildarríki

(í EES)


Tékkland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT 50mg/ml Stungulyf/innrennslislyf, lausn


Danmörk Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Danmörk VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Danmörk Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland


Ferion 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Danmörk Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn




Jerndextran "Pharmacosmos" 50mg/ml Stungulyf/innrennslislyf, lausn


7

Aðildarríki

(í EES)




MonoFer 100mg/ml Stungulyf/innrennslislyf, lausn


Danmörk VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Eistland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Eistland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20mg/ml 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Eistland Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland




Eistland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




8

Aðildarríki

(í EES)


Eistland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Eistland Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia


Ferrum Lek 50mg/ml Stungulyf, lausn Til notkunar í vöðva

Finnland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Finnland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany




Finnland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Finnland Alternova A/S Lodshusvej 11 4230 Skaelskoer Denmark


Venotrix 20mg/ml Innrennslisþykkni, lausn/stungulyf, lausn


9

Aðildarríki

(í EES)


Finnland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Finnland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Frakkland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT 50 mg/ml, solution injectable/pour perfusion



Frakkland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


VENOFER 20mg/ml, solution injectable

20mg/ml Stungulyf, lausn Til notkunar í bláæð

Frakkland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


FERRISAT 50 mg/ml, solution injectable ou pour perfusion



Frakkland Pharmaki Generics Ltd 5 Bourlet Close W1W 7BL London United Kingdom


FER ACTAVIS 100 mg/5 ml, solution injectable


10

Aðildarríki

(í EES)


Frakkland IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier 69003 Lyon France


FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion

100mg/5ml Innrennslisþykkni, lausn


Frakkland Mylan SAS 117, allée des Parcs 69800 Saint-Priest France


FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion



Frakkland SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France


FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion



Frakkland TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE


FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)


Þýskaland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20 mg/ml Injektionslösung/ Konzentrat zur Herstellung einer Infusionslösung

1709mg/5ml

Innrennslisþykkni, lausn/stungulyf, lausn


11

Aðildarríki

(í EES)


Þýskaland Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany


FerMed 1563 - 1887mg/5ml



Þýskaland Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany


Nefro-Fer 1563 - 1887mg/5ml

Stungulyf, lausn Til notkunar í bláæð

Þýskaland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Monofer 100 mg/ml Lösung zur Injektion/Infusion

377-465mg/ml

Stungulyf/innrennslislyf, lausn


Þýskaland Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany


Ferrlecit 40 mg 1288,9mg/3,2ml


Þýskaland Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany


Ferrlecit 62,5 mg 2013,9mg/5ml


Þýskaland Pharmacosmos A/S Roervangsvei 30 Holbaek DK-4300 Denmark


CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5mg/ml Stungulyf/innrennslislyf, lausn


12

Aðildarríki

(í EES)


Þýskaland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France

Járnbundinn karboxýmaltsykur-samstæða

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung



Þýskaland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Venofer 20 mg FR / ml Injektionslösung

2700mg/5ml



Grikkland Medicus SA Valaoritou 10 Metamorfosi Attikis 14452 Greece


REOXYL 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Vianex S.A. Tatoiou Street Nea Erythrea 14671 Greece


INTRAFER 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Alapis ABEE Aftokratoros Nikolaou 2 Athens 17671 Greece


FAREMIO 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Intermed ABEE Kalyftaki 27 Athens 14564 Greece


DEXTRIFER-S 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


13

Aðildarríki

(í EES)


Grikkland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


VENOFER 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Demo ABEE 21ST Km National Highway Athens-Lamia, 14565 Greece

Járnblandað (III) hýdroxíð-dextran

COSMOFER 50mg/ml Stungulyf/innrennslislyf, lausn


Grikkland Rafarm AEBE Korinthou 12, N. Psychiko, 15451 Greece


FERROVIN 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Nephrotech S.A. Parnithos 44 Metamorfosi Attikis 14452 Greece


SUCRO-FER 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Uni-Pharma Kleon Tseitis Pharmaceutical Laboratories 14KM National Highway Athens-Lamia Kifissia 14564 Greece


HEMAFER-S 100mg/5ml Innrennslisþykkni, lausn


Grikkland Verisfield (UK) Ltd, U.K. 41 Chalton street London, NW1 1JD United Kingdom


NEPHROFEROL 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


14

Aðildarríki

(í EES)


Grikkland HELP ABEE Valaoritou 10 Metamorfosi Attikis, 14452 Greece


FERRINEMIA 100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland Specifar AEBE 28th October Street 1 Agia Barbara 12351 Greece


ALVOFER 100mg/5ml Innrennslisþykkni, lausn


Grikkland Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351 Greece


SUCROVEN 100mg/5ml Innrennslisþykkni, lausn


Grikkland Target Pharma Ltd Menandrou 54 Athens 10431 Greece


IRONCROSE 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Grikkland HELP ABEE Valaoritou 10 Metamorfosi Attikis, 14452 Greece


IRONATE 50mg/ml Stungulyf/innrennslislyf, lausn


Grikkland Demo ABEE 21st km National Highway Athens-Lamia, 14565 Greece


MONOFER 100mg/ml Stungulyf/innrennslislyf, lausn


15

Aðildarríki

(í EES)


Grikkland Viofar EPE Ethnikis Antistaseos & Trifyllias, Aharnai, 13671 Greece


VENIRON 100mg/5ml Innrennslisþykkni, lausn


Grikkland Medicus SA Valaoritou 10 Metamorfosi Attikis 14452 Greece


IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES



Ungverjaland

VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Ungverjaland

VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Venofer 20mg/ml Stungulyf/innrennslislyf, lausn


Ungverjaland

Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20mg/ml Stungulyf/innrennslislyf, lausn


16

Aðildarríki

(í EES)


Ungverjaland

Sanofi-Aventis Zrt Tó utca 1-5, 1045 Budapest Hungary

Sódíum járnbundin glókónat-samstæða

Ferrlecit 12,5mg/ml Stungulyf, lausn Til notkunar í bláæð

Ísland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Ísland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Monofer 100mg/ml Innrennslislyf, lausn


Ísland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Venofer 20mg/ml Stungulyf, lausn Til notkunar í bláæð

Írland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


CosmoFer 50mg/ml solution for infusion and injection





Monover 100mg/ml solution for injection/infusion (ampoules)



17

Aðildarríki

(í EES)




Monover 100mg/ml solution for injection/infusion (vials)



Írland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule





FERINJECT 50 mg iron/ml solution for injection/infusion




Járnblönduð súkrosa-samstæða)

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial



Írland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion

20mg/ml Stungulyf, lausn Til notkunar í bláæð

18

Aðildarríki

(í EES)


Ítalía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT 50mg/ml Stungulyf/innrennslislyf, lausn


Ítalía Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


FERRO SACCARATO FME 20mg/ml Innrennslisþykkni, lausn/stungulyf, lausn


Ítalía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


VENOFER 20mg/ml Stungulyf, lausn Til notkunar í bláæð

Ítalía Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy


FERLIXIT 62,5mg/5ml Mixtúra, lausn eða innrennslislyf, lausn

Til inntöku Til notkunar í bláæð

Lettland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




19

Aðildarríki

(í EES)


Lettland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France



Lettland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


FerroLogic 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Lettland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


CosmoFer 50mg/ml Stungulyf/innrennslislyf, lausn


Lettland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Litháen VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Litháen VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France



20

Aðildarríki

(í EES)


Litháen Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany




Litháen Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Litháen Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Lúxemborg VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Injectafer-50mg/l 50mg/ml Stungulyf, lausn Til notkunar í bláæð

Lúxemborg Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Cosmofer-50mg/ml 50mg/ml Stungulyf, lausn Til notkunar í bláæð

Lúxemborg Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany


Fermed-100mg/5ml 100mg/5ml Gegnflæðislausn Til notkunar í bláæð

21

Aðildarríki

(í EES)


Lúxemborg Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic-20mg/ml 20mg/ml Gegnflæðislausn Til notkunar í bláæð

Malta VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France


FERINJECT 50 mg iron/ml solution for injection/infusion



Malta Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany

Járnblönduð súkrosa-samstæða.

Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion



Noregur Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark



Til inndælingar

Noregur VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France



Til inndælingar

22

Aðildarríki

(í EES)


Noregur Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland



Til inndælingar

Noregur Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany



Til inndælingar




Til inndælingar



Uniferon 200mg/ml Stungulyf, lausn Til inndælingar

Noregur VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France



Til inndælingar

Pólland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




23

Aðildarríki

(í EES)


Pólland VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France


Ferinject 50mg/ml Stungulyf, lausn Til notkunar í bláæð

Pólland VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France




Pólland Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg Germany


Ferrologic 20 mg/ml 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Pólland Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria


Ferrum-Lek 50mg/ml Stungulyf, lausn Til notkunar í vöðva

Pólland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Monover 100mg/ml Stungulyf/innrennslislyf, lausn


Portúgal Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Referen 100mg/5ml Stungulyf, lausn Til notkunar í bláæð

24

Aðildarríki

(í EES)


Portúgal Vifor France, SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France


Venofer 100mg/5ml Stungulyf, lausn Til notkunar í bláæð

Portúgal Combino Pharm Portugal, Unipessoal, Lda. Lagoas Park Edifício 8 Piso 0 2740-268 Porto Salvo Portugal


Óxido Férrico Sacarosado Combino


Portúgal Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal


Óxido Férrico Sacarosado Farmoz


Portúgal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal


Óxido Férrico Sacarosado Generis


25

Aðildarríki

(í EES)


Portúgal Laboratórios Normon, S.A. Rua Armando Villar, Lote 42 1º Dto. Quinta das Patinhas, Cobre 2750 - 777 Cascais Portugal


Óxido Férrico Sacarosado Normon


Portúgal Vifor France, SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France




Portúgal Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




Portúgal Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Monofar 100mg/ml Stungulyf/innrennslislyf, lausn


Rúmenía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


VENOFER® 20mg/ml Stungulyf/innrennslislyf, lausn


Rúmenía Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


MONOFER 100 mg/ml 100mg/ml Stungulyf/innrennslislyf, lausn


26

Aðildarríki

(í EES)


Rúmenía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT 50 mg fer/ml 50mg/ml Stungulyf/innrennslislyf, lausn


Slóvakía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Slóvakía Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland


Ferion 20 mg/ml 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Slóvakía Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20 mg/ml 20mg/ml Stungulyf, lausn Innrennslisþykkni, lausn


Slóvakía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France



27

Aðildarríki

(í EES)


Slóvenía Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


Ferrologic 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje



Slóvenía VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France

Karboxýmaltsykur Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje



Slóvenía Lek farmacevtska družba d.d., Verovškova 57, 1000 Ljubljana Slovenia


Venofer 20 mg/ml raztopina za injiciranje/ koncentrat za raztopino za infundiranje



Spánn Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50mg/ml Stungulyf, lausn Innrennslislyf, lausn


Spánn GUERBET B.P. 57400 ROISSY CdG CEDEX F-95943 France


ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION

11,2mg/ml Innrennslisþykkni, dreifa


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Aðildarríki

(í EES)


Spánn G.E.S. Genericos Espanoles Laboratorio S.A.Cólquide, 6 - Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain


FERIV 20mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION



Spánn Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61346 Bad Homburg Germany


HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION



Spánn Laboratorios Normon S.A. Ronda de Valdecarrizo 6 28760 Tres Cantos Madrid Spain


HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION



Spánn Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany


FERMED 100 mg/ 5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

100mg/5ml Stungulyf, lausn Innrennslisþykkni, lausn


Spánn VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION



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Aðildarríki

(í EES)


Spánn VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION



Spánn Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN



Svíþjóð VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France


Venofer® 20mg/ml Stungulyfsþykkni, lausn


Svíþjóð Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


Cosmofer® 50mg/ml Stungulyf, lausn Til notkunar í bláæð

Svíþjóð VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France


Ferinject 50mg/ml Stungulyf, lausn Til notkunar í bláæð

Svíþjóð Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61346 Bad Homburg Germany


Ferrologic 20mg/ml Stungulyfsþykkni, lausn


30

Aðildarríki

(í EES)


Svíþjóð Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland


Ferion 20mg/ml Stungulyfsþykkni, lausn


Svíþjóð Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


MonoFer® 100mg/ml Stungulyf, lausn Til notkunar í bláæð

Holland Pharmamatch B.V. Egelenburg 2 Amsterdam GK - 1081 The Netherlands


IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie



Holland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany


FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie



Holland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


MonoFer 100 mg/ml oplossing voor injectie/infusie



31

Aðildarríki

(í EES)


Holland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie



Holland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France


FERINJECT 50 mg ijzer/ ml, oplossing voor injectie/infusie



Holland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark


CosmoFer 50 mg/ml oplossing voor infusie en injectie



Holland Pharmachemie B.V. Haarlem - 2031 GA The Netherlands


IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie



Bretland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




Bretland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark




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Aðildarríki

(í EES)




Diafer 50mg/ml Stungulyf, lausn Til notkunar í bláæð





Bretland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany




Bretland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France




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