EN Official Journal of the European Union C 311/8

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2013/C 311/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 5.9.2013 Okrido See Annex I See Annex I 6.9.2013 24.9.2013 Deltanil See Annex II See Annex II 26.9.2013 13.9.2013 Iron See Annex III See Annex III 16.9.2013 18.9.2013 Aprotinin See Annex IV See Annex IV 19.9.2013 25.9.2013 Cydectin See Annex V See Annex V 26.9.2013 12.9.2013 Targocid See Annex VI See Annex VI 13.9.2013 5.9.2013 Flupirtine See Annex VII See Annex VII 6.9.2013 6.9.2013 Doramectin See Annex VIII See Annex VIII 9.9.2013 25.9.2013 Diclofenac See Annex IX See Annex IX 26.9.2013 27.9.2013 Ergot derivatives (dihydroergocristine) See Annex X See Annex X 30.9.2013 27.9.2013 Ergot derivatives (dihydroergocryptine) See Annex XI See Annex XI 30.9.2013 27.9.2013 Ergot derivatives (nicergoline) See Annex XII See Annex XII 30.9.2013 27.9.2013 Ergot derivatives (dihydroergotamine) See Annex XIII See Annex XIII 30.9.2013





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 27.9.2013 Ergot derivatives (dihydroergocristine) See Annex X See Annex X 30.9.2013 27.9.2013 Ergot derivatives (dihydroergocryptine) See Annex XI See Annex XI 30.9.2013 27.9.2013 Ergot derivatives (nicergoline) See Annex XII See Annex XII 30.9.2013 27.9.2013 Ergot derivatives (dihydroergotamine) See Annex XIII See Annex XIII 30.9.2013





— Lift of suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 18.9.2013 Aprotinin See Annex IV See Annex IV 19.9.2013

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant Invented name / Name Strength Pharmaceutical form Route of administration Content (concentration) Germany Pharmapol Arzneimittelvertrieb-GmbH, Kaddenbusch 11, 25578 Daegeling, Germany Okrido 6 mg/ml Oral Solution Oral use Netherlands Pharmapol Arzneimittelvertrieb-GmbH, Kaddenbusch 11, 25578 Daegeling, Germany Okrido 6 mg/ml Oral Solution Oral use United Kingdom Pharmapol Arzneimittelvertrieb-GmbH, Kaddenbusch 11, 25578 Daegeling, Germany Okrido 6 mg/ml Oral Solution Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant Name INN Strength Pharmaceutical form Animal species Route of administration Austria Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Solution pour-on pour bovins et ovins Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 100 mg Solution spot-on pour bovins Deltamethrin 10 mg/ml Spot-on solution Cattle Topical use Bulgaria Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Делтанил 10 мг/мл пур он разтвор, предназначен за говеда и овце. Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Cyprus Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml pour-on roztok pro aplikaci na kůži skotu a ovcí Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Denmark Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on opløsning til kvæg og får Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Estonia Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil, 10 mg/ml, kriipsususpensioon veistele ja lammastele Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use France Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Solution pour-on pour bovins et ovins Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use France Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 100 mg Solution spot-on pour bovins Deltamethrin 10 mg/ml Spot-on solution Cattle Topical use Germany Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on Lösung zum Übergießen für Rinder und Schafe Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Germany Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 100 mg Spot- on Lösung zum Auftropfen für Rinder Deltamethrin 10 mg/ml Spot-on solution Cattle Topical use Greece Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Διάλυμα για επίχυση για βοοειδή και πρόβατα Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Hungary Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on szarvasmarha és juh részére Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Iceland Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml áhella, lausn fyrir nautgripi og sauöfé Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Ireland Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on Solution for cattle and sheep Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Italy Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml soluzione Pour-on per bovini ed ovini Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Latvia Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil, 10 mg/ml, šķīdums uzliešanai uz muguras liellopiem un aitām Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Lithuania Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil, 10 mg/ml, užpilamasis tirpalas galvijams ir avims Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Solution pour-on pour bovins et ovins Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use The Netherlands Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on Oplossing voor runderen en schapen Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use The Netherlands Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 100 mg Spot- on Oplossing voor runderen Deltamethrin 10 mg/ml Spot-on solution Cattle Topical use Poland Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10mg/ml, roztwór do polewania dla bydła i owiec Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Portugal Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml solução Spot- on para bovinos e ovinos Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Romania Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml soluție pour-on pentru bovine și ovine Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Slovakia Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE DELTANIL 10 mg/ml Pour-on roztok pre hovädzí dobytok a ovce Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Slovenia Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml raztopina za kožni poliv za govedo in ovce Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use Spain Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml solución pour-on para bovino y ovino Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 10 mg/ml Pour- on Solution for cattle and sheep Deltamethrin 10 mg/ml Pour-on solution Cattle and sheep Topical use United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE Deltanil 100 mg Spot- on Solution for cattle Deltamethrin 10 mg/ml Spot-on solution Cattle Topical use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 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 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/5ml 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 United Kingdom 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

ANNEX IV LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Aprotinin containing medicinal products with Marketing Authorisation in the European Union Member State (EU/EEA) Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration AT - Austria Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Austria Trasylol 10 000 KIE/ml - Infusionsflasche 10 000 KIU/ml solution for infusion intravenous use BE-Belgium Belgium Bayer S.A. 14, J.E. Mommaertslaan B- 1831 Diegem Belgium Trasylol 10 000 KIU/ml solution for infusion intravenous use CZ - Czech Republic Chemical Works of Gedeon Richter Plc., HU-1103 Budapest, Gyömrői út 19-21., Hungary Gordox 10 ku/ml solution for injection intravenous use CZ - Czech Republic Bayer Schering Pharma AG Mullerstrasse 178 13353 Berlin Germany Trasylol 500 000 KIE 10 ku/ml solution for infusion intravenous use DE - Germany Bayer Pharma Aktiengesellschaft registered business address: Müllerstr. 178 D-13353 Berlin postal address: D-13342 Berlin Trasynin 0,5 70,0 mg /50 ml solution for infusion intravenous use DE - Germany Bayer Pharma Aktiengesellschaft registered business address: Müllerstr. 178 D-13353 Berlin postal address: D-13342 Berlin Trasynin 1,0 140,0 mg /100 ml solution for infusion intravenous use DE - Germany Bayer Pharma Aktiengesellschaft registered business address: Müllerstr. 78 D-13353 Berlin postal address: D-13342 Berlin Trasynin 2,0 280,0 mg /200 ml solution for infusion intravenous use DE - Germany Bayer Vital GmbH D-51373 Leverkusen Trasylol 0,5 70,0 mg /50 ml solution for infusion intravenous use DE - Germany Bayer Vital GmbH D-51373 Leverkusen Trasylol 1,0 140,0 mg /100 ml solution for infusion intravenous use DE - Germany Bayer Vital GmbH D-51373 Leverkusen Trasylol 2,0 280,0 mg /200 ml solution for infusion intravenous use DK - Denmark Bayer Schering Pharma AG, Müllerstrasse 170-178, DE-13342 Berlin, Germany Trasylol 10 000 KIE/ml solution for injection intravenous use EL - Greece Bayer Hellas AG 18 - 20, Sorou Str. 151 25, Marousi - Athens TRASYLOL 500 000 KIU/50ML solution for infusion intravenous use ES - Spain QUIMICA FARMACEUTICA BAYER, S.L Av. Baix Llobregat, 3-5 08970 Sant Joan Despi Barcelona - España TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA 10 000 K 10 000 KIU/ml IU/ml solution for perfusion intravenous use FI - Finland Bayer HealthCare AG, 51368 Leverkusen, Germany TRASYLOL 10 000 KIU/ml solution for injection/infusion intravenous use FR - France BAYER SANTE - 220, avenue de la recherche - 59120 LOOS Trasylol 1 000 000 KUI/100 mL solution for injection intravenous use FR - France BAYER SANTE - 220, avenue de la recherche - 59120 LOOS Trasylol 2 000 000 KUI/200 mL solution for injection intravenous use FR - France BAYER SANTE - 220, avenue de la recherche - 59120 LOOS Trasylol 500 000 UIK/50 mL solution for injection intravenous use HU - Hungary Richter Gedeon Nyrt. Gyömrői út 19-21. 1103 Budapest, Hungary Gordox 100 000 KIU/10 ml solution for injection intravenous use HU - Hungary Richter Gedeon Nyrt. Gyömrői út 19-21. 1103 Budapest, Hungary Gordox 500 000 KIU/50 ml solution for infusion intravenous use HU - Hungary Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39 51368 Leverkusen, Germany Trasylol 500 000 KIU/50 ml solution for infusion intravenous use LU - Luxembourg Bayer S.A. 14, J.E. Mommaertslaan B- 1831 Diegem TRASYLOL 50 000 U/50ml solution for injection intravenous use LV - Latvia Gedeon Richter Ltd. Gyomroi ut 19-21 Budapest HU-1103 Hungary Gordox 10 000 KSV/ml šķīdums infūzijām 10 000 KIU/ml solution for infusion intravenous use MT - Malta Bayer Plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom trading as Bayer Plc, Pharmaceutical division TRASYLOL 10 000 KIU/ML solution for infusion intravenous use NL - Netherlands Bayer B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands Trasylol 500 000, oplossing voor infusie 10 000 KIE/ml 10 000 KIU/ml solution for infusion intravenous use PL - Poland Bayer Pharma AG Berlin, D-13342 Germany Trasylol 555,6 Ph.Eur.u. (1 000 000 KIU) solution for infusion intravenous use PL - Poland Bayer Pharma AG Berlin, D-13342 Germany Trasylol 1 111,1 Ph.Eur.u. (2 000 000 KIU) solution for infusion intravenous use PL - Poland Bayer Pharma AG Berlin, D-13342 Germany Trasylol 277,8 j. Ph. Eur. (500 000 KIU) solution for infusion intravenous use PT - Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal Trasylol 500 000 U.I.C/50 ml solution for infusion intravenous use PT - Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal Trasylol 1 000 000 UIC 1 000 000 U.I.C/100 ml solution for infusion intravenous use PT - Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal Trasylol 2 000 000 UIC 2 000 000 U.I.C/200 ml solution for infusion Intravenous use SE - Sweden Bayer Schering Pharma AG Müllerstrasse 178 DE-133 42 Berlin Germany Trasylol 10 000 KIE/ml solution for injection/infusion intravenous use SK - Slovakia Richter Gedeon Nyrt., Budapest 10, Pf. 27., H-1475 Hungary GORDOX 100 000 IU/10 ml solution for injection intravenous use SL - Slovenia Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia TRASYLOL 10 000 KIU/ml solution for injection and infusion intravenous use UK - United Kingdom Bayer plc Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA UK Trasylol Solution 10,000 KIU/ML solution for injection intravenous use UK - United Kingdom Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park, Theale, Reading, Berkshire RG7 4SA, UK Aprotinin 10,000 KIU/ml Injection 10,000 KIU/ml solution for injection intravenous use

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Name INN Strength Pharmaceutical form Route of administration Animal species Austria Pfizer Corp. Austria G.m.b.H. Floridsdorfer Hauptstraße 1 A - 1210 Wien Austria Cydectin TriclaMox 5 mg/ml + 200 mg/ml lösung zum aufgießen für Rinder Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Belgium Pfizer Animal Health s.a. Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium Cydectin TriclaMox 5 mg/ml + 200 mg/ml Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Denmark Pfizer Oy, Animal Health Tietokuja 4 00330 Helsinki Finland Cydectin TriclaMox Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg France Pfizer Holding France 23-25 avenue du Docteur Lannelongue F – 75668 Paris Cedex 14 France Cydectine TriclaMox 5 mg/ml + 200 mg/ml Solution pour pour-on bovins Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Germany Pfizer GmbH Linkstraße 10 10785 Berlin Germany Cydectin® TriclaMox 5 mg/ml + 200 mg/ml Lösung zum Aufgießen für Rinder Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Greece Pfizer Hellas AE Mesogion Avenue 243 154 51 N. Psychiko Athens Greece Cydectin TriclaMox Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Ireland Pfizer Healthcare Ireland Ringaskiddy Co Cork Ireland Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Italy Pfizer Italia S.r.l. Via Isonzo 71 04100 Latina Italy Cydectin TriclaMox 5 mg/ml + 200 mg/ml soluzione Pour-on per bovini Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Luxembourg Pfizer Animal Health s.a. Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium Cydectin TriclaMox 5 mg/ml + 200 mg/ml Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Portugal Laboratórios Pfizer, Lda Lagoas Park – Edíficio 10 2740-271 Porto Salvo Portugal Cydectin TriclaMox 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Slovenia Pfizer Luxembourg SARL 51, Avenue J.F.Kennedy L-1855 Luxembourg Luksemburg Cydectin TriclaMox Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg Spain Zoetis Spain, S.L. Avda. de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain Cydectin Triclamox 5 mg/ml + 200 mg/ml Solución Pour-on para Bovino Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg United Kingdom Pfizer Ltd Ramsgate Road Sandwich CT13 9NJ United Kingdom Cydectin TriclaMox 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle Moxidectin 5,0 mg Pour-on solution Topical – on the back of the animal Cattle Triclabendazole 200,0 mg

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder company name, address Invented name Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria Targocid 100 mg Trockenstechampullen mit Lösungsmittel 100 mg powder and solvent for solution for injection/ infusion and oral solution intramuscular use, intravenous use, oral use 100 mg/1.5 ml Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria Targocid 200 mg Trockenstechampullen mit Lösungsmittel 200 mg powder and solvent for solution for injection/ infusion and oral solution intramuscular use, intravenous use, oral use 200 mg/3 ml Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria Targocid 400 mg Trockenstechampullen mit Lösungsmittel 400 mg powder and solvent for solution for injection/ infusion and oral solution intramuscular use, intravenous use, oral use 400 mg/3 ml Belgium sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Belgium Targocid 200 mg, poeder en oplosmiddel voor oplossing voor injectie 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Belgium sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Belgium Targocid 400 mg, poeder en oplosmiddel voor oplossing voor injectie 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Bulgaria sanofi-aventis Bulgaria EOOD 1303 Sofia, 103 Alexander Stamboliiski Blvd. fl.8., Bulgaria TARGOCID 400mg powder and solvent for solution for injection/infusion 400 mg powder and solvent for solution for injection/infusion intramuscular use/intravenous use, oral use 400 mg/3 ml Czech Republic sanofi-aventis, s.r.o. Evropská 846/176a, 160 00 Praha 6, Czech Republic Targocid 200 mg 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Czech Republic sanofi-aventis, s.r.o. Evropská 846/176a, 160 00 Praha 6, Czech Republic Targocid 400 mg 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Denmark sanofi-aventis Denmark A/S Slotsmarken 13, 2970 Hoersholm, Denmark Targocid 100 mg powder for solution for injection intramuscular use/intravenous use 100 mg/1.5 ml Denmark sanofi-aventis Denmark A/S Slotsmarken 13, 2970 Hoersholm, Denmark Targocid 200 mg powder for solution for injection intramuscular use/intravenous use 200 mg/3 ml Denmark sanofi-aventis Denmark A/S Slotsmarken 13, 2970 Hoersholm, Denmark Targocid 400 mg powder for solution for injection intramuscular use/intravenous use 400 mg/3 ml Finland sanofi-aventis Oy Huopalahdentie 24 PL 22 00351 Helsinki, Finland Targocid 200 mg injektio- ja infuusiokuiva-aine, liuosta varten 200 mg powder for solution for injection/ infusion intramuscular use/intravenous use 200 mg/3 ml Finland sanofi-aventis Oy Huopalahdentie 24 PL 22 00351 Helsinki, Finland Targocid 400 mg injektio- ja infuusiokuiva-aine, liuosta varten 400 mg powder for solution for injection/ infusion intramuscular use/intravenous use 400 mg/3 ml France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France TARGOCID 100 mg, lyophilisat et solution pour usage parentéral 100 mg powder and solvent for injection intramuscular use/intravenous use 100 mg/1.5 ml France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France TARGOCID 200 mg, lyophilisat et solution pour usage parentéral 200 mg powder and solvent for injection intramuscular use/intravenous use 200 mg/3 ml France sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris, France TARGOCID 400 mg, lyophilisat et solution pour usage parentéral 400 mg powder and solvent for injection intramuscular use/intravenous use 400 mg/3 ml Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926 Frankfurt am Main, Deutschland Targocid® 100 mg 100 mg powder and solvent for solution for infusion/injection or oral solution intramuscular use/intravenous use, oral use 100 mg/1.5 ml Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926 Frankfurt am Main, Deutschland Targocid® 200 mg 200 mg powder and solvent for solution for infusion/injection or oral solution intramuscular use/intravenous use, oral use 200 mg/3 ml Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926 Frankfurt am Main, Deutschland Targocid® 400 mg 400 mg powder and solvent for solution for infusion/injection or oral solution intramuscular use/intravenous use, oral use 400 mg/3 ml Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926 Frankfurt am Main, Deutschland Teicoplanin Sanofi-Aventis 100 mg 100 mg powder and solvent for solution for infusion/injection or oral solution intramuscular use/intravenous use, oral use 100 mg/1.5 ml Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926 Frankfurt am Main, Deutschland Teicoplanin Sanofi-Aventis 200 mg 200 mg powder and solvent for solution for infusion/injection or oral solution intramuscular use/intravenous use, oral use 200 mg/3 ml Germany sanofi-aventis Deutschland GmbH Industriepark Höchst, Geb. K 703, 65926 Frankfurt am Main, Deutschland Teicoplanin Sanofi-Aventis 400 mg 400 mg powder and solvent for solution for infusion/injection or oral solution intramuscular use/intravenous use, oral use 400 mg/3 ml Greece Vianex S.A. Tatoiou Street 14671 Nea Erythrea, Greece TARGOCID® 200 mg Powder and solvent for injection or infusion intramuscular use/intravenous use 200 mg/3 ml Greece Vianex S.A. Tatoiou Street 14671 Nea Erythrea, Greece TARGOCID® 400mg Powder and solvent for injection or infusion intramuscular use/intravenous use 400 mg/3 ml Hungary sanofi-aventis Zrt. 1-5. Tó u., 1045 Budapest, Hungary Targocid 200 mg por és oldószer oldatos injekcióhoz 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Hungary sanofi-aventis Zrt. 1-5. Tó u., 1045 Budapest, Hungary Targocid 400 mg por és oldószer oldatos injekcióhoz 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Ireland sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, Ireland Targocid 200mg Powder and Solvent for Solution for Injection 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Ireland sanofi-aventis Ireland Ltd., T/A Sanofi 18 Riverwalk Citywest Business Campus, Dublin 24, Ireland Targocid 400mg Powder and Solvent for Solution for Injection 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Italy sanofi-aventis SPA Viale L. Bodio, 37/B – 20158 Milano, Italy TARGOSID 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Italy sanofi-aventis SPA Viale L. Bodio, 37/B – 20158 Milano, Italy TARGOSID 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Italy sanofi-aventis SPA Viale L. Bodio, 37/B – 20158 Milano, Italy TEICOMID 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Italy sanofi-aventis SPA Viale L. Bodio, 37/B – 20158 Milano, Italy TEICOMID 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Luxembourg sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Belgium TARGOCID 200 mg powder for injectable preparations intramuscular use/intravenous use 200 mg/3 ml Luxembourg sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem, Belgium TARGOCID 400 mg powder for injectable preparations intramuscular use/intravenous use 400 mg/3 ml Malta Sanofi-Aventis Malta Ltd. Triq Kan. K. Pirotta, Birkirkara BKR1114, Malta Targocid® 200 mg 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Netherlands sanofi-aventis Netherlands BV. Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands TARGOCID® 200 200 mg powder for solution for injection intramuscular use/intravenous use 200 mg/3 ml Netherlands sanofi-aventis Netherlands BV. Kampenringweg 45 D-E, 2803 PE Gouda, The Netherlands TARGOCID® 400 400 mg powder for solution for injection intramuscular use/intravenous use 400 mg/3 ml Norway sanofi-aventis Norge AS, Strandveien 15, PO Box 133, 1325 Lysaker, Norway TARGOCID® 400 mg powder for solution for injection/infusion intramuscular use/intravenous use 400 mg/3 ml Poland Aventis Pharma Ltd. One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom TARGOCID 200 mg powder and solvent for solution for injection and infusion intramuscular use/intravenous use 200 mg/3 ml Poland Aventis Pharma Ltd. One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom TARGOCID 400 mg powder and solvent for solution for injection and infusion intramuscular use/intravenous use 400 mg/3 ml Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 – 3o Piso 2740-244 Porto Salvo Portugal Targosid 200 mg/3 ml powder and solvent for solution for injection or for infusion intramuscular use/intravenous use 200 mg/3 ml Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7 – 3o Piso 2740-244 Porto Salvo Portugal Targosid 400 mg/3 ml powder and solvent for solution for injection or for infusion intramuscular use/intravenous use 400 mg/3 ml Romania Aventis Pharma Ltd. Trading as sanofi-aventis or Sanofi One Onslow Street, Guildford Surrey, GU1 4YS, United Kingdom TARGOCID® 200 mg 200 mg powder and solvent for solution for injection intramuscular use/intravenous use 200 mg/3 ml Romania Aventis Pharma Ltd. Trading as sanofi-aventis or Sanofi One Onslow Street, Guildford Surrey, GU1 4YS, United Kingdom TARGOCID® 400 mg 400 mg powder and solvent for solution for injection intramuscular use/intravenous use 400 mg/3 ml Slovak Republic sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovak Republic Targocid 200 200 mg powder and solvent for solution for injection or infusion intramuscular use/intravenous use, oral use 200 mg/3 ml Slovak Republic sanofi-aventis Pharma Slovakia s.r.o Einsteinova 24, 85101 Bratislava, Slovak Republic Targocid 400 400 mg powder and solvent for solution for injection or infusion intramuscular use/intravenous use, oral use 400 mg/3 ml Slovenia sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia Targocid 200 mg prašek in vehikel za raztopino za injiciranje ali infundiranje 200 mg powder and solvent for solution for injection or infusion intramuscular use/intravenous use 200 mg/3 ml Slovenia sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia Targocid 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje 400 mg powder and solvent for solution for injection or infusion intramuscular use/intravenous use 400 mg/3 ml Spain Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Spain TARGOCID 200 mg powder and solvent for solution for injection or infusion intramuscular use/intravenous use 200 mg/3 ml Spain Marion Merrell S.A. Martínez Villergas, 52 28027 Madrid Spain TARGOCID 400 mg powder and solvent for solution for injection or infusion intramuscular use/intravenous use 400 mg/3 ml Sweden sanofi-aventis AB Box 14142 167 14 Bromma, Sweden Targocid 200 mg Powder for injection-/infusion, solution intramuscular use/intravenous use 200 mg/3 ml Sweden sanofi-aventis AB Box 14142 167 14 Bromma, Sweden Targocid 400 mg Powder for injection-/infusion, solution intramuscular use/intravenous use 400 mg/3 ml United Kingdom Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma) One Onslow Street Guildford Surrey GU1 4YS United Kingdom or trading as Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey GU1 4YS United Kingdom TARGOCID® 200 mg powder for injection intramuscular use/intravenous use 200 mg/3 ml United Kingdom Aventis Pharma Ltd. (or trading as Marion Merrell or Aventis Pharma) One Onslow Street Guildford Surrey GU1 4YS United Kingdom or trading as Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey GU1 4YS United Kingdom TARGOCID® 400 mg powder for injection intramuscular use/intravenous use 400 mg/3 ml

ANNEX VII LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State (in EEA) Marketing authorisation holder Product name Strength Pharmaceutical form Route of administration Bulgaria Zentiva k.s. 130 U kabelovn Prague 10237 Czech Republic Flupizen 100 mg capsule, hard oral use Estonia Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands KATADOLON 100 mg capsule, hard oral use Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany Flupirtinmaleat AbZ 100 mg Kapseln 100 mg capsule, hard oral use Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Flupirtinmaleat AL 100 mg Hartkapseln 100 mg capsule, hard oral use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Awegal inject 164,5 mg / 3 ml solution for injection intramuscular use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Katadolon inject 164,5 mg / 3 ml solution for injection intramuscular use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Katadolon Kinderzäpfchen 75 mg suppository rectal use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Katadolon Zäpfchen 150 mg suppository rectal use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Trancopal Dolo 100 mg capsule oral use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Trancopal Dolo Suppositorien 150 mg suppository rectal use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Katadolon S long 400 mg prolonged release tablet oral use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Katadolon 100 mg capsule, hard oral use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Trancolong 400 mg prolonged release tablet oral use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Katadolon retard 400 mg prolonged release tablet oral use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 01445 Radebeul Germany Flupirtinmaleat Winthrop 400 mg Retardtabletten 400 mg prolonged release tablet oral use Germany CT Arzneimittel GmmbH Graf-Arco-Str. 3 89079 Ulm Germany Flupirtinmaleat-CT 100 mg Hartkapsel 100 mg capsule, hard oral use Germany CT Arzneimittel GmmbH Graf-Arco-Str. 3 89079 Ulm Germany Flupin 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany Dolokadin einmal täglich 400 mg prolonged release tablet oral use Germany Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Germany Flupigamma 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Germany Flupirtinmaleat-Hormosan 100 mg Hartkapseln 100 mg capsule, hard oral use Germany MEDA Pharma GmbH & Co. KG Benzstr. 1 61352 Bad Homburg Germany Flupigil 100 mg Hartkapseln 100 mg capsule, hard oral use Germany MEDA Pharma GmbH & Co. KG Benzstr. 1 61352 Bad Homburg Germany Flupigil 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Midas Pharma GmbH Rheinstr. 49 55218 Ingelheim Germany Flupirtinmaleat Midas 100 mg Hartkapseln 100 mg capsule, hard oral use Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany Flupirtinmaleat-ratiopharm 100 mg Hartkapsel 100 mg capsule, hard oral use Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany Miflumal 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Vitapharma Generics GmbH Benzstr. 1 61352 Bad Homburg v. d. H. Germany Flupirtinmaleat Vitapharma 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Vitapharma Generics GmbH Benzstr. 1 61352 Bad Homburg v. d. H. Germany Flupivil 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Vitapharma Generics GmbH Benzstr. 1 61352 Bad Homburg v. d. H. Germany Flupirtinmaleat Viatris 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Flupirtinmaleat Winthrop 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Flupimal 100 mg Hertkapseln 100 mg capsule, hard oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Flupsadim 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Miphaflumix 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Fluporol 100 mg Hartkapseln 100 mg capsule, hard oral use Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany Flupirtinmaleat Winthrop 100 mg Hartkapseln 100 mg capsule, hard oral use Hungary ZENTIVA k.s. Ul. kabelovny 130, Dolní Mecholupy 10237 Prague 10 Czeh Republic Flupizen 100 mg kemény kapszula 100 mg capsule, hard oral use Italy MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano Italy EFIRET 100 mg capsule, hard oral use Latvia Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht The Netherlands Katadolon 100 mg hard capsules 100 mg capsule, hard oral use Lithuania Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands Katadolon 100 mg capsule, hard oral use Poland Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warsaw Poland Katadolon 100 mg capsule, hard oral use Portugal Midas Pharma GmbH Rheinstrasse, 49 55218 Ingelheim Germany Flupirtina Midas 100 mg capsule, hard oral use Portugal Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal Flupirtina Winthrop 100 mg capsule, hard oral use Portugal Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Portugal Metanor 100 mg capsule, hard oral use Romania Zentiva k.s. U Kabelovny 130, Dolní Měcholupy 102 37, Praga 10, Czech Republic FLUPIZEN 100 mg 100 mg capsule oral use Slovak Republic Zentiva k.s. U Kabelovny 130 102 37 Praha 10 Czech Republic Flupizen 100 mg tvrdé kapsuly 100 mg capsule, hard oral use Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o. Teslova 26 821 02 Bratislava Slovak Republic Katadolon 100 mg capsule, hard oral use

ANNEX VIII LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Applicant/marketing authorisation holder Name INN Strength Pharmaceutical form Route of administration Animal species Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1, 1210 Wien AUSTRIA Dectomax 1 % - Injektionslösung für Rinder und Schafe Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1, 1210 Wien AUSTRIA Dectomax S 10 mg/ml Injektionslösung für Schweine Doramectin 10 mg/ml Solution for injection intramuscular Pigs Austria Pfizer Corporation Austria Gesellschaft m.b.H. Floridsdorfer Hauptstraße 1, 1210 Wien AUSTRIA Dectomax Pour-On 5 mg/ml Lösung für Rinder Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Belgium Eli Lilly Benelux S.A. Division Elanco Animal Health Stoofstraat 52 1000 Brussel BELGIUM DECTOMAX Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep Belgium Eli Lilly Benelux S.A. Division Elanco Animal Health Stoofstraat 52 1000 Brussel BELGIUM DECTOMAX POUR-ON Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Belgium Eli Lilly Benelux S.A. Division Elanco Animal Health Stoofstraat 52 1000 Brussel BELGIUM DECTOMAX SOLUTION INJECTABLE POUR PORCS Doramectin 10 mg/ml Solution for injection intramuscular Pigs Bulgaria Pfizer S.A., Z.l. De Poce-sur-Cisse, B.P. 109 37401 Amboise Cedex, FRANCE Дектомакс 1 % инжективен разтвор Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Bulgaria BIOVET AD 39 Petar Rakov str. Peshtera 4550 BULGARIA Ендектовет 1 % инжекционен разтвор за говеда, овце и свине Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Cyprus PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE DECTOMAX 1 % ενέσιμο διάλυμα για βοοειδή, χοίρους και πρόβατα Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Czech republic Pfizer s.r.o. Stroupežnického 17 150 00 Praha CZECH REPUBLIC DECTOMAX 10 mg/ml injekční roztok Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Czech republic Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM Prontax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Denmark Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax Pour-On Vet. Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Denmark Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax Vet. Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, pigs Denmark Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Denmark Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 10 mg/ml Solution for injection subcutaneous Cattle Estonia Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM Dectomax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Estonia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM Prontax 10 mg/ml Solution for injection for Cattle, Sheep and Pigs Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Finland Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND DECTOMAX vet 10 mg/ml injektioneste, liuos Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, reindeer, pigs Finland Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax 5 mg/ml kertavaleluliuos Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Finland Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax 10 mg/ml injektioneste, liuos Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs France Lilly France 13 Rue Pages 92158 Suresnes Cedex FRANCE ZEARL Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep France Lilly France 13 Rue Pages 92158 Suresnes Cedex FRANCE ZEARL POUR ON Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle France Lilly France 13 Rue Pages 92158 Suresnes Cedex FRANCE ZEARL PORCS Doramectin 10 mg/ml Solution for injection intramuscular Pigs France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM PRONTAX 5 MG/ML SOLUTION POUR POUR ON POUR BOVINS Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM PRONTAX 10 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS ET PORCINS Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Germany Lilly Deutschland GmbH Teichweg 3 35396 Gießen GERMANY Dectomax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep Germany Lilly Deutschland GmbH Teichweg 3 35396 Gießen GERMANY Dectomax Pour-On Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Germany Lilly Deutschland GmbH Teichweg 3 35396 Gießen GERMANY Dectomax-S Injektionslösung Doramectin 10 mg/ml Solution for injection intramuscular Pigs Greece PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE DECTOMAX ing sol Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Hungary Pfizer Kft. Alkotás u. 53. 1123 Budapest HUNGARY Dectomax injekció A.U.V. Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Iceland Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax, vet. Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Iceland Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Iceland Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Ireland Elanco Animal Health Eli Lilly & Company Limited Lilly House Priestly Road Basingstoke, Hampshire RG24 9NL UNITED KINGDOM Zearl Pour-On Solution for Cattle 5 mg/ml Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Ireland Elanco Animal Health Eli Lilly & Company Limited Lilly House Priestly Road Basingstoke, Hampshire RG24 9NL UNITED KINGDOM Zearl 10 mg/ml Solution for Injection for Cattle and Sheep Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep Ireland Elanco Animal Health Eli Lilly & Company Limited Lilly House Priestly Road Basingstoke, Hampshire RG24 9NL UNITED KINGDOM Zearl 10 mg/ml Solution for Injection for Pigs Doramectin 10 mg/ml Solution for injection intramuscular Pigs Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM Dectomax 5 mg/ml Pour-On Solution for Cattle Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina ITALY DECTOMAX 10 mg/ml soluzione iniettabile per bovini, ovini e suini Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina ITALY DECTOMAX POUR ON 5 mg/ml Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Latvia Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIUM Dectomax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Latvia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM Dectomax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Lithuania Pfizer S.A., Z.l. De Poce-sur-Cisse, B.P. 109 37401 Amboise Cedex, FRANCE DECTOMAX, injekcinis tirpalas galvijams, avims ir kiaulėms Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Lithuania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM PRONTAX 10 mg/ml, injekcinis tirpalas galvijams, avims ir kiaulėms Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs The Netherlands Pfizer Animal Health B.V. Rivium Westlaan 142 2909 LD Capelle a/d IJssel THE NETHERLANDS Dectomax Pour-On Oplossing voor Rundvee 5 mg/ml Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle The Netherlands Pfizer Animal Health B.V. Rivium Westlaan 142 2909 LD Capelle a/d IJssel THE NETHERLANDS DECTOMAX oplossing voor injectie 10 mg/ml voor rundvee, varkens en schapen Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Norway Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax Pour-On vet Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Norway Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax vet Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Norway Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Norway Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Poland Pfizer Trading Polska s.p. z o.o. ul. Postępu 17 B 02-676 Warszawa POLAND Dectomax 10 mg/ml, roztwór do wstrzykiwań dla bydła, świń i owiec Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Portugal LABORATÓRIOS PFIZER, LDA. Lagoas Park - Edifício 10 2740-244 Porto Salvo PORTUGAL Dectomax Pour-on Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Portugal LABORATÓRIOS PFIZER, LDA. Lagoas Park - Edifício 10 2740-244 Porto Salvo PORTUGAL Dectomax solução injectável Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM DECTOMAX Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM PRONTAX 10 mg/ml Injectable Solution for Cattle, Sheep and Pigs Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ UNITED KINGDOM PRONTAX 5 mg/ml Pour On Solution for Cattle Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Slovakia Pfizer Luxemburg SARL, o.z. Pfizer AH Pribinova 25 811 09 Bratislava SLOVAK REPUBLIC Dectomax 10 mg/ml injekčný roztok Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Slovenia Pfizer Luxembourg SARL 51, Avenue J.F. Kennedy L-1855 Luxembourg LUXEMBOURG DECTOMAX 10 mg/ml raztopina za injiciranje Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Spain PFIZER S.A. Avda. de Europa 20 B. Parque Empresarial La Moraleja 28108 - Alcobendas Madrid SPAIN DECTOMAX 10 MG/ML SOLUCIÓN INYECTABLE PARA PORCINO Doramectin 10 mg/ml Solution for injection intramuscular Pigs Spain PFIZER S.A. Avda. de Europa 20 B. Parque Empresarial La Moraleja 28108 - Alcobendas Madrid SPAIN DECTOMAX POUR-ON SOLUCION 5 MG/ML PARA BOVINO Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Spain PFIZER S.A. Avda. de Europa 20 B. Parque Empresarial La Moraleja 28108 - Alcobendas Madrid SPAIN DECTOMAX SOLUCION INYECTABLE Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep Sweden Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax vet. Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, reindeer Sweden Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax Suis vet. Doramectin 10 mg/ml Solution for injection intramuscular Pigs Sweden Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep, pigs Sweden Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Dectomax pour-on vet. Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle Sweden Pfizer Oy, Animal Health, Tietokuja 4 00330 Helsinki FINLAND Prontax Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle United Kingdom Elanco Animal Health Eli Lilly & Company Limited Lilly House Priestly Road Basingstoke, Hampshire RG24 9NL UNITED KINGDOM Dectomax 10 mg/ml Solution for Injection for Cattle and Sheep Doramectin 10 mg/ml Solution for injection subcutaneous, intramuscular Cattle, sheep United Kingdom Elanco Animal Health Eli Lilly & Company Limited Lilly House Priestly Road Basingstoke, Hampshire RG24 9NL UNITED KINGDOM Dectomax 10 mg/ml Solution for Injection for Pigs Doramectin 10 mg/ml Solution for injection intramuscular Pigs United Kingdom Elanco Animal Health Eli Lilly & Company Limited Lilly House Priestly Road Basingstoke, Hampshire RG24 9NL UNITED KINGDOM Dectomax Pour-on Solution for Cattle 5 mg/ml Doramectin 5 mg/ml Pour-on solution topical - on the back of the animal Cattle

ANNEX IX LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State (in EEA) Marketing authorisation holder INN Invented name Strengths Pharmaceutical forms Routes of administration Austria Pfizer Corporation Austria Ges.m.b.H Floridsdorfer Hauptstraße 1, 1210 Vienna Austria Diclofenac sodium Misoprostol Arthrotec forte - Manteltabletten 75 mg 0,2 mg Coated tablet Oral use Austria Pfizer Corporation Austria Ges.m.b.H Floridsdorfer Hauptstraße 1, 1210 Vienna Austria Diclofenac sodium Misoprostol Arthrotec - Manteltabletten 50 mg 0,2 mg Coated tablet Oral use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Dedolor akut 75 mg – Kapseln 75 mg Gastro-resistant capsule, hard Oral use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Dedolor DRS 100 mg – Kapseln 100 mg Capsule, hard Oral use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Deflamat DRS 75 mg – Kapseln 75 mg Capsule, hard Oral use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Deflamat 75 mg - Ampullen 75 mg/3 ml Solution for injection/infusion Intramuscular use, Intravenous use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Deflamat 50 mg – Kapseln 50 mg Capsule, hard Oral use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Deflamat 100 mg – Suppositorien 100 mg Suppository Rectal use Austria Astellas Pharma GmbH Linzer Straße 221/E02 1140 Vienna Austria Diclofenac sodium Deflamat retard 100 mg – Kapseln 100 mg Capsule, hard Oral use Austria Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium DiclacHexal 50 mg - Filmtabletten 50 mg Film-coated tablet Oral use Austria Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium DiclacHexal rapid 50 mg - lösbare Tabletten 50 mg Soluble tablet Oral use Austria Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium DiclacHexal retard 150 mg - Tabletten 150 mg Prolonged-release tablet Oral use Austria Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium DiclacHexal retard 75 mg - Tabletten 75 mg Prolonged-release tablet Oral use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene 75 mg – Ampullen 75 mg/2 ml Solution for injection/infusion Intramuscular use, Intravenous use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene 25 mg – Filmtabletten 25 mg Film-coated tablet Oral use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene 50 mg – Filmtabletten 50 mg Film-coated tablet Oral use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene 100 mg – Zäpfchen 100 mg Suppository Rectal use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene 50 mg – Zäpfchen 50 mg Suppository Rectal use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene retard 100 mg - Kapseln 100 mg Capsule, hard Oral use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac sodium Diclobene uno 150 mg - Retardtabletten 150 mg Prolonged-release tablet Oral use Austria 1A Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten 50 mg Soluble tablet Oral use Austria Genericon Pharma Gesellschaft m.b.H. Hafnerstraße 211 8054 Graz Austria Diclofenac sodium Diclofenac Genericon 75 mg - Ampullen 75 mg/3 ml Solution for injection/infusion Intramuscular use, Intravenous use Austria Genericon Pharma Gesellschaft m.b.H. Hafnerstraße 211 8054 Graz Austria Diclofenac sodium Diclofenac "Genericon" 50 mg - Filmtabletten 50 mg Film-coated tablet Oral use Austria Genericon Pharma Gesellschaft m.b.H. Hafnerstraße 211 8054 Graz Austria Diclofenac sodium Diclofenac Genericon retard 100 mg Filmtabletten 100 mg Film-coated tablet Oral use Austria S.MED Handels GmbH Zachgasse 1 1220 Vienna Austria Diclofenac sodium DICLOFENAC "S.Med" 25 mg-Filmtabletten 25 mg Film-coated tablet Oral use Austria S.MED Handels GmbH Zachgasse 1 1220 Vienna Austria Diclofenac sodium DICLOFENAC "S.Med" 50 mg - Filmtabletten 50 mg Film-coated tablet Oral use Austria S.MED Handels GmbH Zachgasse 1 1220 Vienna Austria Diclofenac sodium Diclofenac ”S.Med“ 75 mg/3 ml - Ampullen 75 mg/3 ml Solution for injection Intramuscular use Austria S.MED Handels GmbH Zachgasse 1 1220 Vienna Austria Diclofenac sodium DICLOFENAC "S.Med" retard 100 mg - Tabletten 100 mg Tablet Oral use Austria S.MED Handels GmbH Zachgasse 1 1220 Vienna Austria Diclofenac sodium DICLOFENAC "S.Med" retard 75 mg - Tabletten 75 mg Tablet Oral use Austria G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Diclofenac sodium Diclofenac G.L. 50 mg - Filmtabletten 50 mg Film-coated tablet Oral use Austria 1A Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Diclofenac 1A Pharma retard 150 mg - Tabletten 150 mg Prolonged-release tablet Oral use Austria 1A Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Diclofenac 1A Pharma retard 75 mg - Tabletten 75 mg Prolonged-release tablet Oral use Austria G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Diclofenac sodium Diclofenac G.L. retard 100 mg - Filmtabletten 100 mg Film-coated tablet Oral use Austria Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Austria Diclofenac sodium Diclofenac Sandoz 75 mg – Ampullen 75 mg/3 ml Solution for injection/infusion Intramuscular use, Intravenous use Austria Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Austria Diclofenac sodium Diclofenac Sandoz 50 mg – Filmtabletten 50 mg Film-coated tablet Oral use Austria Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Austria Diclofenac sodium Diclofenac Sandoz 150 mg - Retardtabletten 150 mg Prolonged-release tablet Oral use Austria Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Austria Diclofenac sodium Diclofenac Sandoz 75 mg - Retardtabletten 75 mg Prolonged-release tablet Oral use Austria Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Austria Diclofenac sodium Diclofenac "Sandoz" retard 100 mg – Filmtabletten 100 mg Film-coated tablet Oral use Austria Lannacher Heilmittel Ges.m.b.H Schlossplatz 1 8502 Lannach Austria Diclofenac sodium Diclo-B „Lannacher“-Kapseln 50 mg Capsule, hard Oral use Austria Lannacher Heilmittel Ges.m.b.H Schlossplatz 1 8502 Lannach Austria Diclofenac sodium Diclo-B G.L. 50 mg Capsule, hard Oral use Austria STADA Arzneimittel GmbH Muthgasse 36 1190 Vienna Austria Diclofenac sodium Diclostad Ampullen 75 mg/3 ml Solution for injection/infusion Intramuscular use, Intravenous use Austria STADA Arzneimittel GmbH Muthgasse 36 1190 Vienna Austria Diclofenac Sodium Diclostad 50 mg Filmtabletten 50 mg Film-coated tablet Oral use Austria STADA Arzneimittel GmbH Muthgasse 36 1190 Vienna Austria Diclofenac sodium Diclostad retard 100 mg Filmtabletten 100 mg Film-coated tablet Oral use Austria G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Diclofenac sodium Diclovit-Kapseln 50 mg Capsule, hard Oral use Austria Fresenius Kabi Austria GmbH Hafnerstrasse 36 Graz A-8055 Austria Diclofenac sodium Dolpasse 75 mg – Infusionslösung 75 mg/250 ml Solution for Infusion Intravenous use Austria Fresenius Kabi Austria GmbH Hafnerstrasse 36 Graz A-8055 Austria Diclofenac sodium Dolpasse retard 100 mg - Filmtabletten 100 mg Film-coated tablet Oral use Austria Fresenius Kabi Austria GmbH Hafnerstrasse 36 Graz A-8055 Austria Diclofenac sodium Orphenadrine citrate Neodolpasse – Infusionslösung 75 mg/250 ml 30 mg/250 ml Solution for Infusion Intravenous use Austria MERCK GesmbH Zimbagasse 5 1147 Vienna Austria Diclofenac sodium Neurofenac - Kapseln 50 mg Capsule, hard Oral use Austria Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Austria Diclofenac sodium Tratul retard 100 mg - Filmtabletten 100 mg Film-coated tablet Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren 25 mg - Filmtabletten 25 mg Film-coated tablet Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren 50 mg - Filmtabletten 50 mg Film-coated tablet Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren 75 mg/3 ml - Injektionslösung 75 mg/3 ml Solution for injection/infusion Intramuscular use, Intravenous use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren 25 mg - Zäpfchen 25 mg Suppository Rectal use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren 100 mg - Zäpfchen für Erwachsene 100 mg Suppository Rectal use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren 50 mg - Zäpfchen für Erwachsene 50 mg Suppository Rectal use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac sodium Voltaren retard 100 mg - Filmtabletten 100 mg Film-coated tablet Oral use Austria Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Austria Diclofenac Acid Tratul 50 mg - Kapseln 50 mg Gastro-resistant capsule, soft Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac Acid Voltaren dispers - lösliche Tabletten 46,5 mg Soluble tablet Oral use Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna Austria Diclofenac potassium Diclobene rapid 50 mg Filmtabletten 50 mg Film-coated tablet Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac potassium Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen 50 mg Powder for oral solution Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria Diclofenac potassium Voltaren rapid 50 mg - Dragees 50 mg Coated tablet Oral use Belgium Continental Pharma Rijksweg, 12 B-2870 Puurs Belgium Diclofenac sodium Misoprostol ARTHROTEC 50 50 mg 0,2 mg Modified-release tablet Oral use Belgium Continental Pharma Rijksweg, 12 B-2870 Puurs Belgium Diclofenac sodium Misoprostol ARTHROTEC 75 75 mg 0,2 mg Modified-release tablet Oral use Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box 1 1800 Vilvoorde Belgium Diclofenac potassium CATAFLAM 50 MG 50 mg Coated tablet Oral use Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box 1 1800 Vilvoorde Belgium Diclofenac potassium CATAFLAM 50 MG 50 mg Powder for oral solution Oral use Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box 1 1800 Vilvoorde Belgium Diclofenac CATAFLAM DISPERSIBLE 46,5 mg Dispersible tablet Oral use Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5, box 8 1090 Jette Belgium Diclofenac sodium DICLOFENAC APOTEX 100 MG 100 mg Prolonged-release tablet Oral use Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5, box 8 1090 Jette Belgium Diclofenac sodium DICLOFENAC APOTEX 75 MG 75 mg Prolonged-release tablet Oral use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac sodium DICLOFENAC EG 100 MG 100 mg Suppository Rectal use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac sodium DICLOFENAC EG 25 MG 25 mg Coated tablet Oral use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac sodium DICLOFENAC EG 50 MG 50 mg Coated tablet Oral use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac sodium DICLOFENAC EG 75 MG 75 mg/3 ml Solution for injection Intramuscular use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac sodium DICLOFENAC EG RETARD 100 MG 100 mg Prolonged-release tablet Oral use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac sodium DICLOFENAC EG RETARD 75 MG 75 mg Prolonged-release tablet Oral use Belgium Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium Diclofenac sodium DICLOFENAC RETARD MYLAN 100 MG 100 mg Prolonged-release tablet Oral use Belgium Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium Diclofenac sodium DICLOFENAC RETARD MYLAN 75 MG 75 mg Prolonged-release tablet Oral use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium Diclofenac sodium DICLOFENAC SANDOZ 50 MG 50 mg Gastro-resistant tablet Oral use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium Diclofenac sodium DICLOFENAC SANDOZ 75 MG 75 mg/3 ml Solution for injection Intramuscular use, Intravenous use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium Diclofenac sodium DICLOFENAC SANDOZ RETARD 100 MG 100 mg Modified-release tablet Oral use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium Diclofenac sod