Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 1 Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use (in EEA) Austria Pharmacosmos A/S Iron (III) hydroxide CosmoFer 50 mg/ml Roervangsvej 30 dextran complex Injektionslösung und Holbaek DK-4300 50mg/ml Infusionslösung Denmark Austria VIFOR France SA Ferric Ferinject 50 mg Eisen/ml 7-13 Boulevard Paul Emile carboxymaltose Injektionslösung oder Victor Konzentrat zur Herstellung 92200 Neuilly-sur-Seine einer Infusionslösung 50mg/ml injection/infusion France Austria Medice Arzneimittel Pütter Iron sucrose FerMed 100 mg/5 ml GmbH & Co KG complex 100mg/5ml Injektionslösung oder injection Kuhloweg 37 Konzentrat zur Herstellung Concentrate for DE-58638 Iserlohn einer Infusionslösung solution for Germany Austria Solution for Intravenous use infusion Fresenius Medical Care Iron sucrose Ferrologic 20 mg/ml Nephrologica Deutschland complex Injektionslösung oder injection GmbH Konzentrat zur Herstellung Concentrate for Else-Kröner-Strasse 1 einer Infusionslösung solution for 20mg/ml 61352 Bad Homburg Solution for Intravenous use infusion Germany Austria Pharmacosmos A/S Iron(III) Monofer 100 mg/ml Roervangsvej 30 isomaltoside Injektions- oder Holbaek DK-4300 complex Infusionslösung Denmark 2 100mg/ml Solution for injection/infusion Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Austria VIFOR France SA Iron sucrose Venofer 20 mg/ml - 7-13 Boulevard Paul Emile complex 20mg/ml Injektionslösung oder injection Victor Konzentrat zur Herstellung Concentrate for 92200 Neuilly-sur-Seine einer Infusionslösung solution for France Belgium infusion Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark Belgium Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monover 100mg/ml Solution for Intravenous use injection/infusion Denmark Belgium Belgium VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml Solution for injection Victor Concentrate for 92521 Neuilly-sur-Seine solution for France infusion VIFOR France SA Ferric 7-13 Boulevard Paul Emile Carboxymaltose Intravenous use Injectafer 50.00 mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Bulgaria VIFOR France SA 7-13 Boulevard Paul Emile Ferric Ferinject 50mg/ml carboxymaltose Solution for injection/infusion Victor 92521 Neuilly-sur-Seine France 3 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Bulgaria Pharmalog AG, Iron sucrose 33 Cherni vrah blvd., complex Idafer 20mg/ml injection 1421 Sofia Bulgaria Bulgaria Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Solution for Intravenous use injection Holbaek DK-4300 Denmark Bulgaria Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml Solution for Intravenous use injection/infusion Denmark Cyprus VIFOR France SA 7-13 Boulevard Paul Emile ferric carboxymaltose Victor FERINJECT SOLUTION FOR 50mg/ml INJECTION OR INFUSION Solution for Intravenous use injection/infusion 50MG IRON/ML 92521 Neuilly-sur-Seine France Cyprus Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Iron(III) isomaltoside complex MONOFER SOLUTION FOR Iron (III) hydroxide dextran complex COSMOFER SOLUTION FOR 100mg/ml INJECTION OR INFUSION Solution for Intravenous use injection/infusion 100MG/ML Denmark Cyprus Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 INJECTION OR INFUSION 50MG IRON/ML Denmark 4 50mg/ml Solution for injection/infusion Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Cyprus The Star Medicines Importers & co ltd, Iron sucrose complex VENOFER INJECTION 100MG Iron sucrose complex FERROLOGIC SOLUTION FOR 100mg/5ml IRON/5ML injection 9A Loukis Akritas Street, P.O.box 50151, 3601 Lemesos, Cyprus Cyprus Fresenius Medical Care Nephrologica Deutschland 20mg/ml INJECTION/CONCENTRATE GmbH FOR SOLUTION FOR Else-Kröner-Strasse 1 INFUSION 20MG/ML Solution for Intravenous use injection/infusion 61352 Bad Homburg Germany Czech VIFOR France SA Iron sucrose Republic 7-13 Boulevard Paul Emile complex VENOFER 20mg/ml Solution for Intravenous use injection Victor 92521 Neuilly-sur-Seine France Czech Fresenius Medical Care Iron sucrose Republic Nephrologica Deutschland complex FERROLOGIC 20 MG/ML 20mg/ml Solution for Intravenous use injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Czech PHARMABIDE LTD Iron sucrose IRON SUCROSE PHARMABIDE Republic 20, Lakonias str, complex 20 MG/ML 20mg/ml Solution for injection 15234 Halandri Concentrate for Athens - Greece solution for infusion 5 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Czech Orion Corporation, Iron sucrose Republic Orionintie 1, complex FERION 20 MG/ML 20mg/ml injection FI-02200 Espoo, Concentrate for Finland solution for infusion Czech Sanofi-Aventis, s.r.o. sodium ferric Republic Evropská 846/176a gluconate complex FERRLECIT 12.5mg/ml Solution for Intravenous use injection 160 00 Praha 6 Czech Republic Czech VIFOR France SA ferric Republic 7-13 Boulevard Paul Emile carboxymaltose FERINJECT 50mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Denmark Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark Denmark VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Denmark Orion Corporation, Iron sucrose Orionintie 1, complex Ferion 20mg/ml Solution for injection FI-02200 Espoo, Concentrate for Finland solution for infusion 6 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Denmark Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Denmark Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Jerndextran "Pharmacosmos" 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark Denmark Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex MonoFer 100mg/ml Solution for Intravenous use injection/infusion Denmark Denmark Estonia VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml Solution for Victor Concentrate for 92521 Neuilly-sur-Seine solution for France infusion VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Intravenous use injection Venofer 20mg/ml Solution for injection Victor Concentrate for 92521 Neuilly-sur-Seine solution for France infusion 7 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Estonia Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml 20mg/ml injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Estonia Orion Corporation, Iron sucrose Orionintie 1, complex Ferion 20mg/ml Solution for Intravenous use injection FI-02200 Espoo, Concentrate for Finland solution for infusion Estonia Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use Holbaek DK-4300 Denmark Estonia Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml injection/infusion Denmark Estonia Lek Pharmaceuticals d.d. Iron (III) hydroxide Verovškova 57 dextran complex Ferrum Lek 50mg/ml Solution for Intramuscular use injection 1526 Ljubljana Slovenia Finland VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml Solution for injection/infusion Victor 92521 Neuilly-sur-Seine France 8 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Finland Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Finland VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml Victor Concentrate for 92521 Neuilly-sur-Seine solution for infusion Alternova A/S Iron sucrose Lodshusvej 11 complex Venotrix 20mg/ml Concentrate for Intravenous use solution for 4230 Skaelskoer infusion/solution Denmark Finland Intravenous use injection France Finland Solution for for injection Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark Finland Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml Solution for Intravenous use injection/infusion Denmark France VIFOR France SA Ferric FERINJECT 50 mg/ml, solution 7-13 Boulevard Paul Emile Carboxymaltose injectable/pour perfusion Victor 92521 Neuilly-sur-Seine France 9 50mg/ml Solution for injection/infusion Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) France VIFOR France SA Iron sucrose VENOFER 20mg/ml, solution 7-13 Boulevard Paul Emile complex injectable Pharmacosmos A/S Iron (III) hydroxide FERRISAT 50 mg/ml, solution Roervangsvej 30 dextran complex injectable ou pour perfusion Pharmaki Generics Ltd Iron sucrose FER ACTAVIS 100 mg/5 ml, 5 Bourlet Close complex solution injectable IBD3 Pharma Consulting Iron sucrose FER IBD3 PHARMA Immeuble l'Orient complex 20mg/ml injection Victor 92521 Neuilly-sur-Seine France France 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark France 100mg/5ml Solution for Intravenous use injection W1W 7BL London United Kingdom France 100mg/5ml Concentrate for CONSULTING 100 mg/5 ml, solution for 10, place Charles solution à diluer pour infusion Béraudier perfusion Intravenous use 69003 Lyon France France Mylan SAS Iron sucrose FER MYLAN 100 mg/5 ml, 117, allée des Parcs complex solution à diluer pour solution for perfusion infusion 69800 Saint-Priest 100mg/5ml Concentrate for Intravenous use France France SANDOZ Iron sucrose FER SANDOZ 100 mg/5 ml, 49, avenue Georges complex solution à diluer pour solution for perfusion infusion Pompidou 92300 Levallois-Perret France 10 100mg/5ml Concentrate for Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) France TEVA SANTE Iron sucrose FER TEVA PHARMA 100 mg/5 100mg/5ml 110, Esplanade du Général complex ml, solution injectable (IV) Fresenius Medical Care Iron sucrose Ferrologic 20 mg/ml Nephrologica Deutschland complex Injektionslösung/ Konzentrat solution for GmbH zur Herstellung einer infusion/solution Else-Kröner-Strasse 1 Infusionslösung for injection injection de Gaulle 92931 Paris La Défense Cedex FRANCE Germany 1709mg/5ml Concentrate for Intravenous use 61352 Bad Homburg Germany Germany Medice Arzneimittel Pütter Iron sucrose GmbH & Co KG complex FerMed 1563 - Concentrate for 1887mg/5ml solution for Kuhloweg 37 infusion/solution DE-58638 Iserlohn for injection Intravenous use Germany Germany Medice Arzneimittel Pütter Iron sucrose GmbH & Co KG complex Nefro-Fer 1563 - Solution for 1887mg/5ml injection Intravenous use Kuhloweg 37 DE-58638 Iserlohn Germany Germany Pharmacosmos A/S Iron(III) Monofer 100 mg/ml Lösung 377- Solution for Roervangsvej 30 isomaltoside zur Injektion/Infusion 465mg/ml injection/infusion Holbaek DK-4300 complex Denmark 11 Intravenous use Member Marketing authorisation State holder INN Invented name Pharmaceutical Route of form administration 1288.9mg/3.2 Solution for Intravenous use ml injection 2013.9mg/5m Solution for l injection 312.5mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use Strength (in EEA) Germany Sanofi-Aventis sodium ferric Deutschland GmbH gluconate complex Ferrlecit 40 mg Brüningstrasse 50, D-65926 Frankfurt am Main Germany Germany Sanofi-Aventis sodium ferric Deutschland GmbH gluconate complex Ferrlecit 62,5 mg Intravenous use Brüningstrasse 50, D-65926 Frankfurt am Main Germany Germany Pharmacosmos A/S Iron (III) hydroxide CosmoFer 50 mg/ml Roervangsvei 30 dextran complex Injektionslösong und Holbaek DK-4300 Infusionslösung Denmark Germany VIFOR France SA Ferric FERINJECT 50 mg Eisen/ml 7-13 Boulevard Paul Emile carboxymaltose Injektions- und Victor complex Infusionslösung VIFOR France SA Iron sucrose Venofer 20 mg FR / ml 7-13 Boulevard Paul Emile complex Injektionslösung 180mg/ml injection/infusion 92521 Neuilly-sur-Seine France Germany 2700mg/5ml Concentrate for solution for Victor infusion/solution 92521 Neuilly-sur-Seine for injection France 12 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Greece Greece Medicus SA Iron sucrose Valaoritou 10 complex REOXYL 100mg/5ml injection Metamorfosi Concentrate for Attikis 14452 solution for Greece infusion Vianex S.A. Iron sucrose Tatoiou Street complex INTRAFER 100mg/5ml Solution for Intravenous use injection Nea Erythrea 14671 Concentrate for Greece solution for infusion Greece Alapis ABEE Iron sucrose Aftokratoros Nikolaou 2 complex FAREMIO 100mg/5ml Solution for Intravenous use injection Athens 17671 Concentrate for Greece solution for infusion Greece Intermed ABEE Iron sucrose Kalyftaki 27 complex DEXTRIFER-S 100mg/5ml Solution for Intravenous use injection Athens 14564 Concentrate for Greece solution for infusion Greece VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex VENOFER 100mg/5ml Solution for injection Victor Concentrate for 92521 Neuilly-sur-Seine solution for France infusion 13 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use (in EEA) Greece Demo ABEE Iron (III) hydroxide 21ST Km National dextran COSMOFER 50mg/ml Highway Athens-Lamia, 14565 Greece Greece Rafarm AEBE Iron sucrose Korinthou 12, complex FERROVIN 100mg/5ml injection N. Psychiko, 15451 Concentrate for Greece solution for infusion Greece Nephrotech S.A. Iron sucrose Parnithos 44 complex SUCRO-FER 100mg/5ml Solution for Intravenous use injection Metamorfosi Attikis 14452 Concentrate for Greece solution for infusion Greece Uni-Pharma Kleon Tseitis Iron sucrose Pharmaceutical complex HEMAFER-S 100mg/5ml Concentrate for Intravenous use solution for Laboratories infusion 14KM National Highway Athens-Lamia Kifissia 14564 Greece Greece Verisfield (UK) Ltd, U.K. Iron sucrose 41 Chalton street complex NEPHROFEROL 100mg/5ml Solution for injection London, NW1 1JD Concentrate for United Kingdom solution for infusion 14 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Greece Greece HELP ABEE Iron sucrose Valaoritou 10 complex FERRINEMIA 100mg/5ml injection Metamorfosi Concentrate for Attikis, 14452 solution for Greece infusion Specifar AEBE Iron sucrose 28th October Street 1 complex ALVOFER 100mg/5ml Concentrate for Intravenous use solution for Agia Barbara 12351 infusion Greece Greece Alet Pharmaceuticals Iron sucrose M. Alexander 121, complex SUCROVEN 100mg/5ml Concentrate for Intravenous use solution for Agia Varvara, 12351 infusion Greece Greece Target Pharma Ltd Iron sucrose Menandrou 54 complex IRONCROSE 20mg/ml Solution for Intravenous use injection Athens 10431 Concentrate for Greece solution for infusion Greece HELP ABEE Iron (III) hydroxide Valaoritou 10 dextran complex IRONATE 50mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use injection/infusion intramuscular use Metamorfosi Attikis, 14452 Greece Greece Demo ABEE Iron(III) 21st km National Highway isomaltoside Athens-Lamia, 14565 complex MONOFER Greece 15 100mg/ml Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Concentrate for Intravenous use (in EEA) Greece Viofar EPE Iron sucrose Ethnikis Antistaseos & complex VENIRON 100mg/5ml solution for Trifyllias, infusion Aharnai, 13671 Greece Greece Medicus SA Iron (III) hydroxide IRON (III)-HYDROXIDE Valaoritou 10 dextran complex DEXTRAN Metamorfosi COMPLEX/BIOMEDIC Attikis 14452 LABORATORIES 50mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use Greece Hungary VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml injection/infusion Victor 92521 Neuilly-sur-Seine France Hungary VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Hungary Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml Solution for injection/infusion GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany 16 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Hungary Sanofi-Aventis Zrt Sodium ferric Tó utca 1-5, gluconate complex Ferrlecit 12.5mg/ml injection 1045 Budapest Hungary Iceland VIFOR France SA ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Iceland Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml Solution for Intravenous use infusion Denmark Iceland VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml Solution for Intravenous use injection Victor 92521 Neuilly-sur-Seine France Ireland Pharmacosmos A/S Iron (III) hydroxide CosmoFer 50mg/ml solution Roervangsvej 30 dextran complex for infusion and injection Pharmacosmos A/S Iron(III) Monover 100mg/ml solution Roervangsvej 30 isomaltoside for injection/infusion Holbaek DK-4300 complex (ampoules) 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark Ireland Denmark 17 100mg/ml Solution for injection/infusion Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Ireland Pharmacosmos A/S Iron(III) Monover 100mg/ml solution Roervangsvej 30 isomaltoside for injection/infusion (vials) Holbaek DK-4300 complex 100mg/ml injection/infusion Denmark Ireland VIFOR France SA Iron sucrose Venofer 20 mg iron/ml 7-13 Boulevard Paul Emile complex solution for injection or 20mg/ml injection Victor concentrate for solution for Concentrate for 92521 Neuilly-sur-Seine infusion, ampoule solution for France Ireland Solution for Intravenous use infusion VIFOR France SA ferric FERINJECT 50 mg iron/ml 7-13 Boulevard Paul Emile carboxymaltose solution for injection/infusion VIFOR France SA Iron sucrose Venofer 20 mg iron/ml 7-13 Boulevard Paul Emile complex) solution for injection or 50mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Ireland Victor concentrate for solution for 92521 Neuilly-sur-Seine infusion, vial 20mg/ml Solution for Intravenous use injection/infusion France Ireland Fresenius Medical Care Iron sucrose FerroLogic 20 mg/ml solution Nephrologica Deutschland complex for injection/concentrate for GmbH solution for infusion Else-Kröner-Strasse 1 61352 Bad Homburg Germany 18 20mg/ml Solution for injection Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Italy VIFOR France SA ferric 7-13 Boulevard Paul Emile carboxymaltose FERINJECT 50mg/ml injection/infusion Victor 92521 Neuilly-sur-Seine France Italy Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex FERRO SACCARATO FME 20mg/ml Concentrate for Intravenous use solution for GmbH infusion/solution Else-Kröner-Strasse 1 for injection 61352 Bad Homburg Germany Italy VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex VENOFER 20mg/ml Solution for Intravenous use injection Victor 92521 Neuilly-sur-Seine France Italy Sanofi-Aventis SPA sodium ferric Viale Luigi Bodio, 37/B gluconate complex FERLIXIT 62,5mg/5ml 20158 Milano Oral solution or Oral use solution for Intravenous use infusion Italy Latvia VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml Solution for injection/infusion Victor 92521 Neuilly-sur-Seine France 19 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Latvia VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml injection Victor 92521 Neuilly-sur-Seine France Latvia Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex FerroLogic 20mg/ml Solution for Intravenous use injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Latvia Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex CosmoFer 50mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use Holbaek DK-4300 Denmark Latvia Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml injection/infusion Denmark Lithuania VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml Solution for injection/infusion Victor 92521 Neuilly-sur-Seine France 20 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Lithuania VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml injection Victor 92521 Neuilly-sur-Seine France Lithuania Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml Solution for Intravenous use injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Lithuania Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml Solution for Intravenous use injection/infusion Denmark Lithuania Pharmacosmos A/S Ferric (III) hydroxide Roervangsvej 30 dextran complex CosmoFer 50mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use Holbaek DK-4300 Denmark Luxembourg VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Injectafer-50mg/l 50mg/ml injection Victor 92521 Neuilly-sur-Seine France Luxembourg Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer-50mg/ml 50mg/ml Solution for injection Holbaek DK-4300 Denmark 21 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Luxembourg Medice Arzneimittel Pütter Iron sucrose GmbH & Co KG complex Fermed-100mg/5ml 100mg/5ml perfusion Kuhloweg 37 DE-58638 Iserlohn Germany Luxembourg Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic-20mg/ml 20mg/ml Solution for Intravenous use perfusion GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Malta VIFOR France SA ferric FERINJECT 50 mg iron/ml 50mg/ml Solution for 7-13 Boulevard Paul Emile carboxymaltose solution for injection/infusion Fresenius Medical Care Iron sucrose Ferrologic 20 mg/ml solution Nephrologica Deutschland complex. for injection/concentrate for injection solution for infusion Concentrate for Intravenous use injection/infusion Victor 92200 Neuilly-sur-Seine France Malta GmbH 20mg/ml Solution for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Intravenous use Germany Norway Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Solution for injection/infusion Holbaek DK-4300 Denmark 22 Parenteral use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Parenteral use (in EEA) Norway VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml injection/infusion Victor 92521 Neuilly-sur-Seine France Norway Orion Corporation, Iron sucrose Orionintie 1, complex Ferion 20mg/ml Solution for Parenteral use injection FI-02200 Espoo, Concentrate for Finland solution for infusion Norway Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml Solution for Parenteral use injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Norway Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml Solution for Parenteral use injection/infusion Denmark Norway Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Uniferon 200mg/ml Solution for injection Holbaek DK-4300 Denmark 23 Parenteral use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Parenteral use (in EEA) Norway Poland VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 20mg/ml injection Victor Concentrate for 92521 Neuilly-sur-Seine solution for France infusion Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex CosmoFer 50mg/ml Solution for Intravenous use injection/infusion Holbaek DK-4300 Denmark Poland VIFOR France SA ferric 123 Rue Jules Guesde carboxymaltose Ferinject 50mg/ml Solution for Intravenous use injection 92200 Neuilly-sur-Seine France Poland VIFOR France SA Iron sucrose 123 Rue Jules Guesde complex Venofer 20mg/ml Solution for Intravenous use injection/infusion 92200 Neuilly-sur-Seine France Poland Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20 mg/ml 20mg/ml Intravenous use injection GmbH Concentrate for 61346 Bad Homburg solution for Germany Poland Solution for infusion Sandoz GmbH Iron(III) Biochemiestrasse 10 isomaltoside A-6250 Kundl complex Ferrum-Lek 50mg/ml Solution for injection Austria 24 Intramuscular use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Poland Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monover 100mg/ml injection/infusion Denmark Portugal Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Referen 100mg/5ml Solution for Intravenous use injection GmbH Else-Kröner-Strasse 1 61352 Bad Homburg Germany Portugal Vifor France, SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer 100mg/5ml Solution for Intravenous use injection Victor 92200 Neuilly-sur-Seine France Portugal Combino Pharm Portugal, Iron sucrose Óxido Férrico Sacarosado Unipessoal, Lda. complex Combino 100mg/5ml Solution for injection Lagoas Park Edifício 8 Piso 0 2740-268 Porto Salvo Portugal 25 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Portugal Farmoz - Sociedade Iron sucrose Óxido Férrico Sacarosado Técnico Medicinal, S.A. complex Farmoz Generis Farmacêutica, Iron sucrose Óxido Férrico Sacarosado S.A. complex Generis Laboratórios Normon, S.A. Iron sucrose Óxido Férrico Sacarosado Rua Armando Villar, complex Normon Vifor France, SA Ferric Ferinject 7-13 Boulevard Paul Emile carboxymaltose 100mg/5ml injection Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal Portugal 100mg/5ml Solution for Intravenous use injection Rua João de Deus, 19 2700-487 Amadora Portugal Portugal 100mg/5ml Solution for Intravenous use injection Lote 42 1º Dto. Quinta das Patinhas, Cobre 2750 - 777 Cascais Portugal Portugal 50mg/ml Solution for Intravenous use injection/infusion Victor 92200 Neuilly-sur-Seine France Portugal Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer 50mg/ml Holbaek DK-4300 Denmark 26 Solution for Intravenous use injection/infusion intramuscular use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Portugal Pharmacosmos A/S Iron (III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofar 100mg/ml injection/infusion Denmark Romania VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex VENOFER® 20mg/ml Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use injection/infusion intramuscular use Solution for Intravenous use Victor 92521 Neuilly-sur-Seine France Romania Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex MONOFER 100 mg/ml 100mg/ml Denmark Romania VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose FERINJECT 50 mg fer/ml 50mg/ml Victor 92521 Neuilly-sur-Seine France Slovak VIFOR France SA Ferric Republic 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml injection/infusion Victor 92521 Neuilly-sur-Seine France Slovak Orion Corporation, Iron sucrose Republic Orionintie 1, complex Ferion 20 mg/ml 20mg/ml Solution for injection FI-02200 Espoo, Concentrate for Finland solution for infusion 27 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Slovak Fresenius Medical Care Iron sucrose Republic Nephrologica Deutschland complex Ferrologic 20 mg/ml 20mg/ml injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany Slovak VIFOR France SA Iron sucrose Republic 7-13 Boulevard Paul Emile complex Venofer 20mg/ml Solution for Intravenous use injection Victor 92521 Neuilly-sur-Seine France Slovenia Fresenius Medical Care Iron sucrose Ferrologic 20 mg/ml raztopina Nephrologica Deutschland complex za injiciranje/ koncentrat za injection raztopino za infundiranje Concentrate for GmbH 20mg/ml Solution for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Intravenous use Germany Slovenia VIFOR France SA carboxymaltose 7-13 Boulevard Paul Emile Iroprem 50 mg/ml raztopina 50mg/ml za iniciranje ali infundiranje Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France Slovenia Lek farmacevtska družba Iron sucrose Venofer 20 mg/ml raztopina d.d., complex za injiciranje/ koncentrat za injection raztopino za infundiranje Concentrate for Verovškova 57, 20mg/ml Solution for 1000 Ljubljana solution for Slovenia infusion 28 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use intramuscular use (in EEA) Spain Pharmacosmos A/S Iron (III) hydroxide COSMOFER 50 mg/ml Roervangsvej 30 dextran complex SOLUCION PARA PERFUSION injection E INYECCION Solution for Holbaek DK-4300 50mg/ml Denmark Spain Spain infusion GUERBET B.P. Iron sucrose ENDOREM 11,2 mg FE/ml 57400 ROISSY CdG complex CONCENTRADO PARA 11,2mg/ml suspension for CEDEX F-95943 SUSPENSION PARA infusion France PERFUSION 20mg/ml Concentrate for G.E.S. Genericos Iron sucrose FERIV 20mg/ml SOLUCION Espanoles Laboratorio complex INYECTABLE O injection S.A.Cólquide, 6 - Portal 2, CONCENTRADO PARA Concentrate for 1 Oficina F.Las Rozas SOLUCION PARA PERFUSION solution for 28230 MADRID Solution for Intravenous use Intravenous use infusion Spain Spain Fresenius Medical Care Iron sucrose HIERRO SACAROSA FME 20 Nephrologica Deutschland complex 20mg/ml Solution for mg/ml SOLUCION injection GmbH INYECTABLE O Concentrate for Else-Kröner-Strasse 1 CONCENTRADO PARA solution for 61346 Bad Homburg SOLUCION PARA PERFUSION infusion Intravenous use Germany Spain Laboratorios Normon S.A. Iron sucrose HIERRO SACAROSA NORMON Ronda de Valdecarrizo 6 complex 20mg/ml Solution for 20 mg/ml SOLUCION injection 28760 Tres Cantos INYECTABLE O Concentrate for Madrid CONCENTRADO PARA solution for Spain SOLUCION PARA PERFUSION infusion 29 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Spain Medice Arzneimittel Pütter Iron sucrose FERMED 100 mg/ 5 ml GmbH & Co KG complex 100mg/5ml SOLUCION INYECTABLE O injection Kuhloweg 37 CONCENTRADO PARA Concentrate for DE-58638 Iserlohn SOLUCION PARA PERFUSION solution for Germany Spain infusion VIFOR France SA Iron sucrose VENOFER 20 mg/ml 7-13 Boulevard Paul Emile complex 20mg/ml SOLUCION INYECTABLE O injection Victor CONCENTRADO PARA Concentrate for 92521 Neuilly-sur-Seine SOLUCION PARA PERFUSION solution for France Spain Solution for Intravenous use infusion VIFOR France SA Ferric FERINJECT 50 mg/ml 7-13 Boulevard Paul Emile carboxymaltose SOLUCION INYECTABLE Y injection PARA PERFUSION Solution for Victor 50mg/ml 92521 Neuilly-sur-Seine Solution for Intravenous use infusion France Spain Pharmacosmos A/S Iron(III) MONOFERRO 100 mg/ml 100mg/ml Roervangsvej 30 isomaltoside SOLUCIÓN INYECTABLE O injection Holbaek DK-4300 complex PARA PERFUSIÓN Solution for Denmark Sweden Solution for Intravenous use infusion VIFOR France SA Iron sucrose 7-13 Boulevard Paul Emile complex Venofer® 20mg/ml Concentrate for Intravenous use solution for Victor injection 92200 Neuilly-sur-Seine France Sweden Pharmacosmos A/S Iron (III) hydroxide Roervangsvej 30 dextran complex Cosmofer® 50mg/ml Solution for injection Holbaek DK-4300 Denmark 30 Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) Sweden VIFOR France SA Ferric 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml injection Victor 92200 Neuilly-sur-Seine France Sweden Fresenius Medical Care Iron sucrose Nephrologica Deutschland complex Ferrologic 20mg/ml Concentrate for Intravenous use solution for GmbH injection Else-Kröner-Strasse 1 61346 Bad Homburg Germany Sweden Orion Corporation, Iron sucrose Orionintie 1, complex Ferion 20mg/ml Concentrate for Intravenous use solution for FI-02200 Espoo, injection Finland Sweden Pharmacosmos A/S Iron(III) Roervangsvej 30 isomaltoside Holbaek DK-4300 complex MonoFer® 100mg/ml Solution for Intravenous use injection Denmark The Pharmamatch B.V. Iron sucrose IJzerhydroxide sacharose Netherlands Egelenburg 2 complex complex bevattende 20 mg/ml injection Amsterdam GK - 1081 IJzer PHARMAMATCH, Concentrate for The Netherlands oplossing/concentraat voor solution for oplossing voor injectie infusion 31 20mg/ml Solution for Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) The Fresenius Medical Care Iron sucrose FerroLogic 20 mg/ml, Netherlands Nephrologica Deutschland complex 20mg/ml oplossing voor injectie of injection GmbH concentraat voor oplossing Concentrate for Else-Kröner-Strasse 1 voor infusie solution for 61352 Bad Homburg infusion Germany The Pharmacosmos A/S Iron(III) MonoFer 100 mg/ml oplossing Netherlands Roervangsvej 30 isomaltoside voor injectie/infusie Holbaek DK-4300 complex 100mg/ml Solution for Intravenous use injection/infusion Denmark The VIFOR France SA Iron sucrose Venofer 20 mg/ml ijzer (III), Netherlands 7-13 Boulevard Paul Emile complex oplossing voor injectie of 20mg/ml injection Victor concentraat voor oplossing Concentrate for 92521 Neuilly-sur-Seine voor intraveneuze infusie solution for France Solution for Intravenous use infusion The VIFOR France SA Ferric FERINJECT 50 mg ijzer/ ml, Netherlands 7-13 Boulevard Paul Emile carboxymaltose oplossing voor injectie/infusie 50mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France The Pharmacosmos A/S Iron (III) hydroxide CosmoFer 50 mg/ml oplossing Netherlands Roervangsvej 30 dextran complex voor infusie en injectie Holbaek DK-4300 Denmark 32 50mg/ml Solution for injection/infusion Intravenous use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) The Pharmachemie B.V. Iron sucrose IJzerhydroxide sacharose Netherlands Haarlem - 2031 GA complex complex 20 mg/ml PCH, injection oplossing voor Concentrate for injectie/concentraat voor solution for oplossing voor infusie infusion The Netherlands United VIFOR France SA Iron sucrose Kingdom 7-13 Boulevard Paul Emile complex Venofer 20mg/ml 20mg/ml Solution for Intravenous use injection/infusion Victor 92521 Neuilly-sur-Seine France United Pharmacosmos A/S Iron(III) Kingdom Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Monofer 100mg/ml Solution for Intravenous use injection/infusion Denmark United Pharmacosmos A/S Iron(III) Kingdom Roervangsvej 30 isomaltoside Holbaek DK-4300 complex Diafer 50mg/ml Solution for Intravenous use injection Denmark United Pharmacosmos A/S Iron (III) hydroxide Kingdom Roervangsvej 30 dextran complex Cosmofer 50mg/ml Holbaek DK-4300 Denmark 33 Solution for Intravenous use injection/infusion intramuscular use Member Marketing authorisation State holder INN Invented name Strength Pharmaceutical Route of form administration Solution for Intravenous use (in EEA) United Fresenius Medical Care Iron sucrose Kingdom Nephrologica Deutschland complex Ferrologic 20mg/ml injection GmbH Concentrate for Else-Kröner-Strasse 1 solution for 61352 Bad Homburg infusion Germany United VIFOR France SA Ferric Kingdom 7-13 Boulevard Paul Emile carboxymaltose Ferinject 50mg/ml Solution for injection/infusion Victor 92521 Neuilly-sur-Seine France 34 Intravenous use
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