Trasylol KIE/ml - Infusionsflasche

Transcription

1 Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states 1

2 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 KIE/ml - Infusionsflasche KIU/ml solution for infusion BE-Belgium Belgium Bayer S.A. 14, J.E. Mommaertslaan B Diegem Belgium Trasylol KIU/ml solution for infusion CZ - Czech Republic Chemical Works of Gedeon Richter Plc., HU-1103 Budapest, Gyömrői út , Hungary Gordox 10 ku/ml solution for injection CZ - Czech Republic Bayer Schering Pharma AG Mullerstrasse Berlin Trasylol KIE 10 ku/ml solution for infusion Bayer Pharma Aktiengesellschaft registered business address: Müllerstr. 178 D Berlin postal address: D Berlin Trasynin 0, mg /50 ml solution for infusion 2

3 Bayer Pharma Aktiengesellschaft registered business address: Müllerstr. 178 D Berlin postal address: D Berlin Bayer Pharma Aktiengesellschaft registered business address: Müllerstr. 78 D Berlin postal address: D Berlin Bayer Vital GmbH D Leverkusen Trasynin 1, mg /100 ml solution for infusion Trasynin 2, mg /200 ml solution for infusion Trasylol 0, mg /50 ml solution for infusion Bayer Vital GmbH D Leverkusen Trasylol 1, mg /100 ml solution for infusion Bayer Vital GmbH D Leverkusen Trasylol 2, mg /200 ml solution for infusion DK - Denmark Bayer Schering Pharma AG, Müllerstrasse , DE Berlin, Trasylol KIE/ml solution for injection 3

4 EL - Greece Bayer Hellas AG 18-20, Sorou Str , Marousi - Athens TRASYLOL KIU/50ML solution for infusion ES - Spain QUIMICA FARMACEUTICA BAYER, S.L Av. Baix Llobregat, Sant Joan Despi Barcelona - España FI - Finland Bayer HealthCare AG, Leverkusen, TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA K KIU/ml IU/ml solution for perfusion TRASYLOL KIU/ml solution for injection/infusion FR - France BAYER SANTE - 220, avenue de la recherche LOOS Trasylol KUI/100 ml solution for injection FR - France BAYER SANTE - 220, avenue de la recherche LOOS Trasylol KUI/200 ml solution for injection FR - France BAYER SANTE - 220, avenue de la recherche LOOS Trasylol UIK/50 ml solution for injection HU - Hungary Richter Gedeon Nyrt. Gyömrői út Budapest, Hungary Gordox KIU/10 ml solution for injection 4

5 HU - Hungary Richter Gedeon Nyrt. Gyömrői út Budapest, Hungary Gordox KIU/50 ml solution for infusion HU - Hungary Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E Leverkusen, Trasylol KIU/50 ml solution for infusion LU - Luxembourg Bayer S.A. 14, J.E. Mommaertslaan B Diegem TRASYLOL U/50ml solution for injection LV - Latvia Gedeon Richter Ltd. Gyomroi ut Budapest HU-1103 Hungary Gordox KSV/ml šķīdums infūzijām KIU/ml solution for infusion MT - Malta Bayer Plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom trading as Bayer Plc, Pharmaceutical division TRASYLOL 10000KIU/ML solution for infusion NL - Netherlands Bayer B.V. Energieweg RT Mijdrecht The Netherlands Trasylol , oplossing voor infusie KIE/ml KIU/ml solution for infusion 5

6 PL - Poland Bayer Pharma AG Berlin, D Trasylol 555,6 Ph.Eur.u. ( KIU) solution for infusion PL - Poland Bayer Pharma AG Berlin, D Trasylol 1111,1 Ph.Eur.u. ( KIU) solution for infusion PL - Poland Bayer Pharma AG Berlin, D-13342, Trasylol 277,8 j. Ph. Eur. ( KIU) solution for infusion PT - Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Trasylol U.I.C/50 ml solution for infusion PT - Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Trasylol UIC U.I.C/100 ml solution for infusion PT - Portugal Bayer Portugal, S.A. Rua Quinta do Pinheiro Carnaxide Portugal Trasylol UIC U.I.C/200 ml solution for infusion Intravenous use SE - Sweden Bayer Schering Pharma AG Müllerstrasse 178 DE Berlin Trasylol KIE/ml solution for injection/infusion 6

7 SK - Slovakia Richter Gedeon Nyrt., Budapest 10, Pf. 27., H-1475 Hungary GORDOX IU/10 ml solution for injection SL - Slovenia Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia TRASYLOL KIU/ml solution for injection and infusion UK - United Kingdom UK - United Kingdom Bayer plc Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA UK Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park, Theale, Reading, Berkshire RG7 4SA, UK Trasylol Solution 10,000 KIU/ML solution for injection Aprotinin 10,000 KIU/ml Injection 10,000 KIU/ml solution for injection 7