EN Official Journal of the European Union C 23/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 December 2004 to 15 January 2005

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

(2005/C 23/02)

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 17.12.2004 Xeristar Boehringer Ingelheim International GmbH, Binger Straße 173, D-55216 Ingelheim am Rhein EU/1/04/297/001-004 22.12.2004 17.12.2004 Cymbalta Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-004 22.12.2004 17.12.2004 Kivexa Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/04/298/001-002 22.12.2004 12.1.2004 Avastin Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/04/300/001-002 14.1.2005

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 17.12.2004 Agenerase Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/148/001-004 22.12.2004 17.12.2004 Fuzeon Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/03/252/001-003 22.12.2004 17.12.2004 Kaletra Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/172/001-003 22.12.2004 17.12.2004 Epivir Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/96/015/001-005 22.12.2004 17.12.2004 Telzir Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/04/282/001-002 22.12.2004 17.12.2004 Invirase Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom EU/1/96/026/001 22.12.2004 17.12.2004 Emtriva Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/03/261/001-003 22.12.2004 17.12.2004 NeuroBloc Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland EU/1/00/166/001-003 23.12.2004 17.12.2004 Reyataz Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom EU/1/03/267/001-007 22.12.2004 17.12.2004 Ziagen Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/112/001-002 22.12.2004 17.12.2004 Rilutek Aventis Pharma SA, 20 Avenue Raymond Aron, F-92165 Antony Cedex EU/1/96/010/001 22.12.2004 17.12.2004 Viracept Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/97/054/001 EU/1/97/054/003-006 22.12.2004 21.12.2004 Advate Baxter AG, Industriestraße 67, A-1221 Wien EU/1/03/271/001-004 23.12.2004 22.12.2004 Iscover Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA United Kingdom EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b 4.1.2005 22.12.2004 Tasmar Valeant Pharmaceuticals Limited, Cedarwood, Chineham Business Park, Crockford lane, Basingstoke RG24 8WD, United Kingdom Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/97/044/001-006 4.1.2005 22.12.2004 Taxotere Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex EU/1/95/002/001-002 24.12.2004 5.1.2005 Crixivan Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 7.1.2005 5.1.2005 Caelyx Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel EU/1/96/011/001-004 7.1.2005 5.1.2005 Taxotere Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex EU/1/95/002/001-002 7.1.2005 5.1.2005 Glivec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/011-013 7.1.2005 5.1.2005 Sustiva Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA United Kingdom EU/1/99/110/001-009 7.1.2005 5.1.2005 Plavix Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France F-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-004b 7.1.2005 5.1.2005 Foscan Biolitec pharma (Ireland) ltd., Unit 2, Broomhill Business Park, Broomhill Road, Tallaght, Dublin 24, Ireland Biolitec pharma limited, Research Avenue South, Heriot-Watt Research Park, Edinburgh, EH14 4AP, United Kingdom EU/1/01/197/001-002 7.1.2005 5.1.2005 Stocrin Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111/001-009 7.1.2005 5.1.2005 Trivizir Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/156/001-003 7.1.2005 5.1.2005 Caelyx Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel EU/1/96/011/001-004 7.1.2005 5.1.2005 Viramune Boehringer Ingelheim International GmbH, Binger Straße 173 D-55216 Ingelheim am Rhein, Deutschland EU/1/97/055/001-002 7.1.2005 5.1.2005 Combivir Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 7.1.2005 10.1.2005 Azomyr Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel EU/1/00/157/001-034 12.1.2005 10.1.2005 Aerius Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel EU/1/00/160/001-034 12.1.2005 10.1.2005 Neoclarityn Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel EU/1/00/161/001-034 12.1.2005 10.1.2005 Ketek Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/191/001-005 12.1.2005 10.1.2005 Levviax Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/192/001-005 12.1.2005 10.1.2005 Glustin Takeda Europe R & D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom EU/1/00/151/001-013 12.1.2005 10.1.2005 Actos Takeda Europe R & D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom EU/1/00/150/001-015 12.1.2005 10.1.2005 Optisulin Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/133/005-007 12.1.2005 10.1.2005 Fortovase Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/075/001-002 12.1.2005 10.1.2005 Remicade Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-003 12.1.2005 10.1.2005 Viread Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom EU/1/01/200/001 12.1.2005 10.1.2005 Vfend Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212/001-026 12.1.2005 10.1.2005 Avandia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom EU/1/00/137/001-012 12.1.2005 11.1.2005 Lantus Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main EU/1/00/134/005-011 EU/1/00/134/013-029 17.1.2005 12.1.2004 Aldurazyme Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland EU/1/03/253/001-003 12.1.2005 12.1.2004 Quixidar Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom NV Organon, PO Box 20, Kloosterstraat 6, 5340 EB Oss, Nederland EU/1/02/207/001-017 14.1.2005 12.1.2004 Arixtra Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom Sanofi-Synthelabo, 174 avenue de France, F-75013 Paris EU/1/02/206/001-017 14.1.2005 12.1.2004 Kaletra Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/01/172/001-003 17.1.2005

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 5.1.2005 Advocate Bayer Healthcare AG, D-51368 Leverkusen EU/2/03/039/001-018 7.1.2005 5.1.2005 ProteqFlu Te Merial, 29 Avenue Tony Garnier, F-69007 Lyon EU/2/03/038/001-004 7.1.2005

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