Member State (in EEA) Marketing authorisation holder INN Invented name Strength Pharmaceutical form Route of administration

Austria Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex CosmoFer 50 mg/ml Injektionslösung und Infusionslösung 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Austria VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung 50 mg/ml Solution for injection/infusion Intravenous use

Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany Iron sucrose complex FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Austria Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Austria Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Injektions- oder Infusionslösung 100 mg/ml Solution for injection/infusion Intravenous use

Austria VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Belgium Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Intravenous use

Belgium Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monover 100 mg/ml Solution for injection/infusion Intravenous use

Belgium VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Belgium VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric Carboxymaltose Injectafer 50,00 mg/ml Solution for injection/infusion Intravenous use

Bulgaria VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Bulgaria Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia Bulgaria Iron sucrose complex Idafer 20 mg/ml Solution for injection Intravenous use

Bulgaria Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection Intravenous use

Bulgaria Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Intravenous use

Cyprus VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France ferric carboxymaltose FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML 50 mg/ml Solution for injection/infusion Intravenous use

Cyprus Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML 100 mg/ml Solution for injection/infusion Intravenous use

Cyprus Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML 50 mg/ml Solution for injection/infusion Intravenous use

Cyprus The Star Medicines Importers & co ltd, 9A Loukis Akritas Street, P.O.box 50151, 3601 Lemesos, Cyprus Iron sucrose complex VENOFER INJECTION 100 MG IRON/5 ML 100 mg/5 ml Solution for injection Intravenous use

Cyprus Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML 20 mg/ml Solution for injection/infusion Intravenous use

Czech Republic VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex VENOFER 20 mg/ml Solution for injection Intravenous use

Czech Republic Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex FERROLOGIC 20 MG/ML 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Czech Republic PHARMABIDE LTD 20, Lakonias str, 15234 Halandri Athens — Greece Iron sucrose complex IRON SUCROSE PHARMABIDE 20 MG/ML 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Czech Republic Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland Iron sucrose complex FERION 20 MG/ML 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Czech Republic Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Praha 6 Czech Republic sodium ferric gluconate complex FERRLECIT 12,5 mg/ml Solution for injection Intravenous use

Czech Republic VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France ferric carboxymaltose FERINJECT 50 mg/ml Solution for injection/infusion Intravenous use

Denmark Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Intravenous use

Denmark VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Denmark Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland Iron sucrose complex Ferion 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Denmark Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Denmark Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Jerndextran ‘Pharmacosmos’ 50 mg/ml Solution for injection/infusion Intravenous use

Denmark Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex MonoFer 100 mg/ml Solution for injection/infusion Intravenous use

Denmark VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Estonia VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Estonia Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Estonia Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland Iron sucrose complex Ferion 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Estonia Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Estonia Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Intravenous use

Estonia Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana Slovenia Iron (III) hydroxide dextran complex Ferrum Lek 50 mg/ml Solution for injection Intramuscular use

Finland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Finland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Finland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Finland Alternova A/S Lodshusvej 11 4230 Skaelskoer Denmark Iron sucrose complex Venotrix 20 mg/ml Concentrate for solution for infusion/solution for injection Intravenous use

Finland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Intravenous use

Finland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Intravenous use

France VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric Carboxymaltose FERINJECT 50 mg/ml, solution injectable/pour perfusion 50 mg/ml Solution for injection/infusion Intravenous use

France VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex VENOFER 20 mg/ml, solution injectable 20 mg/ml Solution for injection Intravenous use

France Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex FERRISAT 50 mg/ml, solution injectable ou pour perfusion 50 mg/ml Solution for injection/infusion Intravenous use

France Pharmaki Generics Ltd 5 Bourlet Close W1W 7BL London United Kingdom Iron sucrose complex FER ACTAVIS 100 mg/5 ml, solution injectable 100 mg/5 ml Solution for injection Intravenous use

France IBD3 Pharma Consulting Immeuble l’Orient 10, place Charles Béraudier 69003 Lyon France Iron sucrose complex FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion 100 mg/5 ml Concentrate for solution for infusion Intravenous use

France Mylan SAS 117, allée des Parcs 69800 Saint-Priest France Iron sucrose complex FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion 100 mg/5 ml Concentrate for solution for infusion Intravenous use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France Iron sucrose complex FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion 100 mg/5 ml Concentrate for solution for infusion Intravenous use

France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE Iron sucrose complex FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV) 100 mg/5 ml Solution for injection Intravenous use

Germany Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung 1 709 mg/5 ml Concentrate for solution for infusion/solution for injection Intravenous use

Germany Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany Iron sucrose complex FerMed 1 563 — 1 887 mg/5 ml Concentrate for solution for infusion/solution for injection Intravenous use

Germany Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany Iron sucrose complex Nefro-Fer 1 563 — 1 887 mg/5 ml Solution for injection Intravenous use

Germany Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Lösung zur Injektion/Infusion 377-465 mg/ml Solution for injection/infusion Intravenous use

Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex Ferrlecit 40 mg 1 288,9 mg/3,2 ml Solution for injection Intravenous use

Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex Ferrlecit 62,5 mg 2 013,9 mg/5 ml Solution for injection Intravenous use

Germany Pharmacosmos A/S Roervangsvei 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex CosmoFer 50 mg/ml Injektionslösong und Infusionslösung 312,5 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Germany VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose complex FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung 180 mg/ml Solution for injection/infusion Intravenous use

Germany VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg FR/ml Injektionslösung 2 700 mg/5 ml Concentrate for solution for infusion/solution for injection Intravenous use

Greece Medicus SA Valaoritou 10 Metamorfosi Attikis 14452 Greece Iron sucrose complex REOXYL 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Vianex S.A. Tatoiou Street Nea Erythrea 14671 Greece Iron sucrose complex INTRAFER 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Alapis ABEE Aftokratoros Nikolaou 2 Athens 17671 Greece Iron sucrose complex FAREMIO 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Intermed ABEE Kalyftaki 27 Athens 14564 Greece Iron sucrose complex DEXTRIFER-S 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex VENOFER 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Demo ABEE 21ST Km National Highway Athens-Lamia, 14565 Greece Iron (III) hydroxide dextran COSMOFER 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Greece Rafarm AEBE Korinthou 12, N. Psychiko, 15451 Greece Iron sucrose complex FERROVIN 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Nephrotech S.A. Parnithos 44 Metamorfosi Attikis 14452 Greece Iron sucrose complex SUCRO-FER 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Uni-Pharma Kleon Tseitis Pharmaceutical Laboratories 14KM National Highway Athens-Lamia Kifissia 14564 Greece Iron sucrose complex HEMAFER-S 100 mg/5 ml Concentrate for solution for infusion Intravenous use

Greece Verisfield (UK) Ltd, U.K. 41 Chalton street London, NW1 1JD United Kingdom Iron sucrose complex NEPHROFEROL 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece HELP ABEE Valaoritou 10 Metamorfosi Attikis, 14452 Greece Iron sucrose complex FERRINEMIA 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece Specifar AEBE 28th October Street 1 Agia Barbara 12351 Greece Iron sucrose complex ALVOFER 100 mg/5 ml Concentrate for solution for infusion Intravenous use

Greece Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351 Greece Iron sucrose complex SUCROVEN 100 mg/5 ml Concentrate for solution for infusion Intravenous use

Greece Target Pharma Ltd Menandrou 54 Athens 10431 Greece Iron sucrose complex IRONCROSE 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Greece HELP ABEE Valaoritou 10 Metamorfosi Attikis, 14452 Greece Iron (III) hydroxide dextran complex IRONATE 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Greece Demo ABEE 21st km National Highway Athens-Lamia, 14565 Greece Iron(III) isomaltoside complex MONOFER 100 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Greece Viofar EPE Ethnikis Antistaseos & Trifyllias, Aharnai, 13671 Greece Iron sucrose complex VENIRON 100 mg/5 ml Concentrate for solution for infusion Intravenous use

Greece Medicus SA Valaoritou 10 Metamorfosi Attikis 14452 Greece Iron (III) hydroxide dextran complex IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Hungary VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Hungary VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection/infusion Intravenous use

Hungary Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Solution for injection/infusion Intravenous use

Hungary Sanofi-Aventis Zrt Tó utca 1-5, 1045 Budapest Hungary Sodium ferric gluconate complex Ferrlecit 12,5 mg/ml Solution for injection Intravenous use

Iceland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Iceland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for infusion Intravenous use

Iceland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Intravenous use

Ireland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex CosmoFer 50 mg/ml solution for infusion and injection 50 mg/ml Solution for injection/infusion Intravenous use

Ireland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monover 100 mg/ml solution for injection/infusion (ampoules) 100 mg/ml Solution for injection/infusion Intravenous use

Ireland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monover 100 mg/ml solution for injection/infusion (vials) 100 mg/ml Solution for injection/infusion Intravenous use

Ireland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Ireland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France ferric carboxymaltose FERINJECT 50 mg iron/ml solution for injection/infusion 50 mg/ml Solution for injection/infusion Intravenous use

Ireland VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex) Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial 20 mg/ml Solution for injection/infusion Intravenous use

Ireland Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion 20 mg/ml Solution for injection Intravenous use

Italy VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France ferric carboxymaltose FERINJECT 50 mg/ml Solution for injection/infusion Intravenous use

Italy Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex FERRO SACCARATO FME 20 mg/ml Concentrate for solution for infusion/solution for injection Intravenous use

Italy VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex VENOFER 20 mg/ml Solution for injection Intravenous use

Italy Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy sodium ferric gluconate complex FERLIXIT 62,5 mg/5 ml Oral solution or solution for infusion Oral use Intravenous use

Latvia VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Latvia VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Intravenous use

Latvia Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex FerroLogic 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Latvia Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex CosmoFer 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Latvia Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Intravenous use

Lithuania VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Lithuania VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Intravenous use

Lithuania Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Lithuania Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Intravenous use

Lithuania Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Ferric (III) hydroxide dextran complex CosmoFer 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Luxembourg VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Injectafer-50 mg/l 50 mg/ml Solution for injection Intravenous use

Luxembourg Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer-50 mg/ml 50 mg/ml Solution for injection Intravenous use

Luxembourg Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany Iron sucrose complex Fermed-100 mg/5 ml 100 mg/5 ml Solution for perfusion Intravenous use

Luxembourg Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic-20 mg/ml 20 mg/ml Solution for perfusion Intravenous use

Malta VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France ferric carboxymaltose FERINJECT 50 mg iron/ml solution for injection/infusion 50 mg/ml Solution for injection/infusion Intravenous use

Malta Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex. Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Norway Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Parenteral use

Norway VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Parenteral use

Norway Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland Iron sucrose complex Ferion 20 mg/ml Solution for injection Concentrate for solution for infusion Parenteral use

Norway Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Solution for injection Concentrate for solution for infusion Parenteral use

Norway Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Parenteral use

Norway Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Uniferon 200 mg/ml Solution for injection Parenteral use

Norway VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Concentrate for solution for infusion Parenteral use

Poland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex CosmoFer 50 mg/ml Solution for injection/infusion Intravenous use

Poland VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France ferric carboxymaltose Ferinject 50 mg/ml Solution for injection Intravenous use

Poland VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection/infusion Intravenous use

Poland Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Poland Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria Iron(III) isomaltoside complex Ferrum-Lek 50 mg/ml Solution for injection Intramuscular use

Poland Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monover 100 mg/ml Solution for injection/infusion Intravenous use

Portugal Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Referen 100 mg/5 ml Solution for injection Intravenous use

Portugal Vifor France, SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France Iron sucrose complex Venofer 100 mg/5 ml Solution for injection Intravenous use

Portugal Combino Pharm Portugal, Unipessoal, Lda. Lagoas Park Edifício 8 Piso 0 2740-268 Porto Salvo Portugal Iron sucrose complex Óxido Férrico Sacarosado Combino 100 mg/5 ml Solution for injection Intravenous use

Portugal Farmoz — Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal Iron sucrose complex Óxido Férrico Sacarosado Farmoz 100 mg/5 ml Solution for injection Intravenous use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal Iron sucrose complex Óxido Férrico Sacarosado Generis 100 mg/5 ml Solution for injection Intravenous use

Portugal Laboratórios Normon, S.A. Rua Armando Villar, Lote 42 1o Dto. Quinta das Patinhas, Cobre 2750 — 777 Cascais Portugal Iron sucrose complex Óxido Férrico Sacarosado Normon 100 mg/5 ml Solution for injection Intravenous use

Portugal Vifor France, SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Portugal Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Portugal Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Monofar 100 mg/ml Solution for injection/infusion Intravenous use

Romania VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex VENOFER® 20 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Romania Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex MONOFER 100 mg/ml 100 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Romania VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose FERINJECT 50 mg fer/ml 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

Slovak Republic VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection/infusion Intravenous use

Slovak Republic Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland Iron sucrose complex Ferion 20 mg/ml 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Slovak Republic Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Slovak Republic VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection Intravenous use

Slovenia Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Slovenia VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France carboxymaltose Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje 50 mg/ml Solution for injection/infusion Intravenous use

Slovenia Lek farmacevtska družba d.d., Verovškova 57, 1000 Ljubljana Slovenia Iron sucrose complex Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Spain Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION 50 mg/ml Solution for injection Solution for infusion Intravenous use intramuscular use

Spain GUERBET B.P. 57400 ROISSY CdG Cedex F-95943 France Iron sucrose complex ENDOREM 11,2 mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION 11,2 mg/ml Concentrate for suspension for infusion Intravenous use

Spain G.E.S. Genericos Espanoles Laboratorio S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain Iron sucrose complex FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Spain Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61346 Bad Homburg Germany Iron sucrose complex HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Spain Laboratorios Normon S.A. Ronda de Valdecarrizo 6 28760 Tres Cantos Madrid Spain Iron sucrose complex HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Spain Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 DE-58638 Iserlohn Germany Iron sucrose complex FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION 100 mg/5 ml Solution for injection Concentrate for solution for infusion Intravenous use

Spain VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

Spain VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION 50 mg/ml Solution for injection Solution for infusion Intravenous use

Spain Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN 100 mg/ml Solution for injection Solution for infusion Intravenous use

Sweden VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France Iron sucrose complex Venofer® 20 mg/ml Concentrate for solution for injection Intravenous use

Sweden Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer® 50 mg/ml Solution for injection Intravenous use

Sweden VIFOR France SA 7-13 Boulevard Paul Emile Victor 92200 Neuilly-sur-Seine France Ferric carboxymaltose Ferinject 50 mg/ml Solution for injection Intravenous use

Sweden Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61346 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Concentrate for solution for injection Intravenous use

Sweden Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland Iron sucrose complex Ferion 20 mg/ml Concentrate for solution for injection Intravenous use

Sweden Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex MonoFer® 100 mg/ml Solution for injection Intravenous use

The Netherlands Pharmamatch B.V. Egelenburg 2 Amsterdam GK — 1081 The Netherlands Iron sucrose complex IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

The Netherlands Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

The Netherlands Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex MonoFer 100 mg/ml oplossing voor injectie/infusie 100 mg/ml Solution for injection/infusion Intravenous use

The Netherlands VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

The Netherlands VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Ferric carboxymaltose FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie 50 mg/ml Solution for injection/infusion Intravenous use

The Netherlands Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex CosmoFer 50 mg/ml oplossing voor infusie en injectie 50 mg/ml Solution for injection/infusion Intravenous use

The Netherlands Pharmachemie B.V. Haarlem — 2031 GA The Netherlands Iron sucrose complex IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use

United Kingdom VIFOR France SA 7-13 Boulevard Paul Emile Victor 92521 Neuilly-sur-Seine France Iron sucrose complex Venofer 20 mg/ml Solution for injection/infusion Intravenous use

United Kingdom Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Monofer 100 mg/ml Solution for injection/infusion Intravenous use

United Kingdom Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron(III) isomaltoside complex Diafer 50 mg/ml Solution for injection Intravenous use

United Kingdom Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark Iron (III) hydroxide dextran complex Cosmofer 50 mg/ml Solution for injection/infusion Intravenous use intramuscular use

United Kingdom Fresenius Medical Care Nephrologica Deutschland GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Iron sucrose complex Ferrologic 20 mg/ml Solution for injection Concentrate for solution for infusion Intravenous use