EN Official Journal of the European Union C 316/42

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2007 to 30 November 2007

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2007/C 316/05)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 14.11.2007 Olanzapine Neopharma Olanzapine Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF United Kingdom EU/1/07/426/001-011 Coated tablets N05AH03 16.11.2007 14.11.2007 Eucreas Vildagliptin/Metformin hydrochloride Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/425/001-018 Film-coated tablets (Non applicable) 16.11.2007 19.11.2007 Tasigna Nilotinib Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/422/001-004 Capsule, hard L01XE08 21.11.2007 19.11.2007 TORISEL Temsirolimus Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/07/424/001 Concentrate and diluent for solution for infusion (Non applicable) 21.11.2007 23.11.2007 Cyanokit Hydroxocobalamin Merck Santé s.a.s. 37, rue Saint-Romain F-69379 Lyon Cedex 08 EU/1/07/420/001 Powder for solution for infusion V03AB33 27.11.2007

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 8.11.2007 PhotoBarr Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard Nederland EU/1/04/272/001-002 12.11.2007 8.11.2007 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/99/118/001-010 12.11.2007 12.11.2007 Tandemact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/366/001-016 14.11.2007 13.11.2007 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 16.11.2007 13.11.2007 Betaferon Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/95/003/003-006 15.11.2007 13.11.2007 Kepivance Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 15.11.2007 14.11.2007 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/001-008 16.11.2007 19.11.2007 Pegasys Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 21.11.2007 19.11.2007 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 21.11.2007 19.11.2007 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-018 21.11.2007 19.11.2007 Evista Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/98/073/001-004 21.11.2007 19.11.2007 Optruma Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/98/074/001-004 21.11.2007 19.11.2007 Ferriprox Apotex Europe B.V. Darwingweg 20 2333 CR Leiden Nederland EU/1/99/108/002-003 21.11.2007 20.11.2007 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-012 22.11.2007 20.11.2007 Norvir Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 22.11.2007 20.11.2007 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-015 22.11.2007 20.11.2007 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-005 22.11.2007 20.11.2007 Neulasta Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/227/001-003 22.11.2007 20.11.2007 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 22.11.2007 20.11.2007 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 22.11.2007 20.11.2007 Neupopeg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/02/228/001-003 22.11.2007 20.11.2007 Lucentis Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/374/001 22.11.2007 21.11.2007 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 23.11.2007 21.11.2007 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 23.11.2007 21.11.2007 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-016 23.11.2007 21.11.2007 TRIZIVIR Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/002-003 23.11.2007 21.11.2007 Ionsys Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/05/326/001 26.11.2007 21.11.2007 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 23.11.2007 21.11.2007 Zerene Wyeth Research (UK) Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/099/001-006 23.11.2007 21.11.2007 Sonata Wyeth Research (UK) Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/102/001-008 23.11.2007 21.11.2007 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-013 23.11.2007 21.11.2007 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/343/001-005 23.11.2007 22.11.2007 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-003 26.11.2007 22.11.2007 Busilvex Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex EU/1/03/254/001 26.11.2007 22.11.2007 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/283/001-007 26.11.2007 23.11.2007 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-010 27.11.2007 23.11.2007 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 27.11.2007 23.11.2007 Docetaxel Winthrop Aventis Pharma S.A 20, avenue Raymond Aron F-92165 Antony Cedex EU/1/07/384/001-002 27.11.2007 23.11.2007 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-037 27.11.2007 23.11.2007 Taxotere Aventis Pharma S.A 20, avenue Raymond Aron F-92165 Antony Cedex EU/1/95/002/001-002 27.11.2007 29.11.2007 Raptiva Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/04/291/001-002 3.12.2007 30.11.2007 Tandemact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/366/005-016 4.12.2007 30.11.2007 Macugen Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/05/325/001-002 4.12.2007 30.11.2007 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001 4.12.2007 30.11.2007 Agenerase Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 4.12.2007 30.11.2007 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 4.12.2007 30.11.2007 Azopt Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/00/129/001-003 4.12.2007

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 14.11.2007 Meloxivet Meloxicam Janssen Pharmaceutica N.V. Turnhoutseweg 30 B-2340 Beerse EU/2/07/077/001-005 Oral suspension QM01AC06 16.11.2007

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 6.11.2007 SevoFlo Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/2/02/035/001-007 8.11.2007 13.11.2007 Quadrisol Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/97/005/001-009 15.11.2007

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 London E14 4HB United Kingdom

(1) OJ L 136, 30.4.2004, p. 1.