EN Official Journal of the European Union C 268/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2005/C 268/02)

— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 19.9.2005 Tarceva Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/05/311/001-003 21.9.2005

— Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 5.9.2005 Ventavis Schering AG, Müllerstraße 170-178, DE-13342 Berlin EU/1/03/255//001-003 8.9.2005 5.9.2005 Trazec Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB EU/1/01/175/001-021 8.9.2005 5.9.2005 Forsteo Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten EU/1/03/247/001-002 7.9.2005 5.9.2005 Starlix Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB EU/1/01/174/001-021 8.9.2005 7.9.2005 DaTSCAN GE Healthcare Limited, UK-Little Chalfont Bucks HP7 9NA EU/1/00/135/001-002 9.9.2005 7.9.2005 Emtriva Gilead Sciences International Limited, UK-Cambridge CB1 6GT EU/1/03/261/001-003 9.9.2005 7.9.2005 KOGENATE Bayer Bayer AG, DE-51368 Leverkusen EU/1/00/143/001-006 9.9.2005 7.9.2005 Helixate NexGen Bayer AG, DE-51368 Leverkusen EU/1/00/144/001-003 9.9.2005 8.9.2005 Nespo Dompé Biotec S.p.A., Via San Martino, 12, IT-20122 Milano EU/1/01/184/001-056 13.9.2005 8.9.2005 Herceptin Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/00/145/001 13.9.2005 8.9.2005 Xagrid Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP EU/1/04/295/001 13.9.2005 8.9.2005 Kivexa Glaxo Group Ltd, Berkeley Avenue, Greenford, UK-Middlesex UB6 0NN EU/1/04/298/001-002 13.9.2005 8.9.2005 Ziagen Glaxo Group Ltd, Greenford, UK-Middlesex UB6 0NN EU/1/99/112/001-002 13.9.2005 8.9.2005 Aranesp Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda EU/1/01/185/001-056 13.9.2005 8.9.2005 Karvezide Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH EU/1/98/085/001-020 13.9.2005 8.9.2005 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris EU/1/98/086/001-020 13.9.2005 8.9.2005 PegIntron Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel EU/1/00/131/001-050 13.9.2005 8.9.2005 ViraferonPeg Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel EU/1/00/132/001-050 13.9.2005 8.9.2005 Raptiva Serono Europe Limited, 56, Marsh Wall, UK-London E14 9TP EU/1/04/291/001-002 14.9.2005 8.9.2005 Pylobactell Torbet Laboratories Limited, Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, UK-Norfolk NR13 6LH EU/1/98/064/001 13.9.2005 13.9.2005 Infanrix Hexa GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, BE-1330 Rixensart EU/1/00/152/001-018 14.9.2005 13.9.2005 Somavert Pfizer Limited, Sandwich, UK-Kent, CT13 9NJ EU/1/02/240/001-004 14.9.2005 13.9.2005 Hepsera Gilead Sciences International Limited, UK-Cambridge CB1 6GT EU/1/03/251/001 15.9.2005 13.9.2005 Erbitux Merck KGaA, Frankfurter Straße 250, DE-64293 Darmstadt EU/1/04/281/001 14.9.2005 13.9.2005 Dynepo Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex FR-92165 EU/1/02/211/001-009 15.9.2005 13.9.2005 Infanrix Penta GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, BE-1330 Rixensart EU/1/00/153/001-010 14.9.2005 13.9.2005 Mimpara Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda EU/1/04/292/001-012 14.9.2005 13.9.2005 Avandamet SmithKline Beecham plc, 980 Great West Road, Brentford, UK-Middlesex TW8 9GS EU/1/03/258/013-014 14.9.2005 13.9.2005 Karvea Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA EU/1/97/049/001-030 15.9.2005 13.9.2005 Keppra UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel EU/1/00/146/001-029 16.9.2005 13.9.2005 Keppra UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel EU/1/00/146/001-027 16.9.2005 13.9.2005 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris EU/1/97/046/001-030 15.9.2005 15.9.2005 Hepsera Gilead Sciences International Limited, UK-Cambridge CB1 6GT EU/1/03/251/001 20.9.2005 15.9.2005 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten EU/1/04/296/001-006 20.9.2005 15.9.2005 Ariclaim Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein EU/1/04/283/001-007 20.9.2005 15.9.2005 Yentreve Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten EU/1/04/280/001-007 20.9.2005 15.9.2005 Xeristar Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein EU/1/04/297/001-006 20.9.2005 15.9.2005 Bonviva Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/03/265/003-004 20.9.2005 15.9.2005 Bondenza Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY EU/1/03/266/003-004 20.9.2005 15.9.2005 Myocet Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, IE-County Clare EU/1/00/141/001 20.9.2005 15.9.2005 NovoMix Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/00/142/004-005 EU/1/00/142/009-010 20.9.2005 16.9.2005 REYATAZ Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA EU/1/03/267/001-007 20.9.2005 19.9.2005 Ariclaim Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein EU/1/04/283/001-007 21.9.2005 19.9.2005 Arava Aventis Pharma Deutschland GmbH, DE-65926 Frankfurt am Main EU/1/99/118/001-010 21.9.2005 19.9.2005 Yentreve Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten EU/1/04/280/001-007 21.9.2005 19.9.2005 Hexavac Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, FR-69007 Lyon EU/1/00/147/001-012 21.9.2005 22.9.2005 Iscover Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH EU/1/98/070/001a — 001b EU/1/98/070/002a — 002b EU/1/98/070/003a — 003b EU/1/98/070/004a — 001b 26.9.2005 22.9.2005 Plavix Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris EU/1/98/069/001a — 001b EU/1/98/069/002a — 002b EU/1/98/069/003a — 003b EU/1/98/069/004a — 001b 26.9.2005 29.9.2005 Remicade Centocor B.V., Einsteinweg 101, NL-2333 CB Leiden EU/1/99/116/001-003 4.10.2005

— Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 22.9.2005 CEA-Scan Immunomedics GmbH, Otto-Röhm-Straße 69, DE-64293 Darmstadt EU/1/96/023/001 27.9.2005

— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 19.9.2005 Pirsue PFIZER Ltd, Ramsgate Road, Sandwich, UK-Kent CT13 9NJ EU/2/00/027/001-003 21.9.2005

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK-London E14 4HB

(1) OJ L 214 of 24.8.1993, p. 1.