EN Official Journal of the European Union C 77/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008

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

(2008/C 77/02)

— 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 21.2.2008 Myfenax Mycophénolate mofétil Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/438/001-002 Capsule, hard L04AA06 25.2.2008 EU/1/07/438/003-004 Film-coated tablet 21.2.2008 Mycophenolate mofetil Teva Mycophénolate mofétil Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/439/001-002 Capsule, hard L04AA06 25.2.2008 EU/1/07/439/003-004 Film-coated tablet

— 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 6.2.2008 Sebivo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/388/001-002 8.2.2008 6.2.2008 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-007 8.2.2008 6.2.2008 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/188/001-006 8.2.2008 7.2.2008 Ytracis CIS bio international Boite Postale 32 F-91192 Gif-sur-Yvette Cedex EU/1/03/250/001 11.2.2008 7.2.2008 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-012 11.2.2008 7.2.2008 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 11.2.2008 13.2.2008 Eucreas Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/425/001-018 15.2.2008 13.2.2008 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 15.2.2008 14.2.2008 BeneFIX Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/97/047/001-007 18.2.2008 18.2.2008 ATryn LEO Pharma A/S Industriparken 55 DK-2750 Ballerup EU/1/06/355/001-003 20.2.2008 26.2.2008 Januvia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/383/001-018 28.2.2008 26.2.2008 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-073 28.2.2008 26.2.2008 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn EU/1/07/412/001-016 28.2.2008 26.2.2008 NeoRecormon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/031/019-046 28.2.2008 26.2.2008 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-073 28.2.2008 26.2.2008 Xelevia Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/382/001-018 28.2.2008 26.2.2008 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/99/118/001-010 28.2.2008 26.2.2008 NeuroBloc Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/00/166/001-003 28.2.2008 26.2.2008 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 28.2.2008 26.2.2008 Kepivance Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 28.2.2008 28.2.2008 Erbitux Merck KgaA Frankfurter Straße 250 D-64293 Darmstadt EU/1/04/281/002-005 3.3.2008 28.2.2008 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 3.3.2008 28.2.2008 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 3.3.2008 28.2.2008 TRIZIVIR Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/002-003 3.3.2008 28.2.2008 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001 3.3.2008 28.2.2008 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/360/001-011 3.3.2008 28.2.2008 Sebivo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/388/001-002 3.3.2008 28.2.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 3.3.2008 28.2.2008 CellCept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/005/001-006 3.3.2008 28.2.2008 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/050/001-006 EU/1/97/050/009-012 3.3.2008 29.2.2008 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland EU/1/01/179/001 4.3.2008 29.2.2008 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 4.3.2008 29.2.2008 Epoetin alfa Hexal HEXAL Biotech Forschungs GmbH Industriestraße 25 D-83607 Holzkirchen EU/1/07/411/001-016 4.3.2008 29.2.2008 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-043 4.3.2008 29.2.2008 Dynepo Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/02/211/001-005 EU/1/02/211/010-012 4.3.2008 29.2.2008 Cialis Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/237/001-008 4.3.2008 29.2.2008 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/051/001-006 EU/1/97/051/009-012 4.3.2008 29.2.2008 Binocrit Sandoz GmbH Biochemiestraße 10 A-6250 Kundl EU/1/07/410/001-016 4.3.2008 29.2.2008 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/001-032 4.3.2008 29.2.2008 Kivexa Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/04/298/001-003 4.3.2008

— 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 13.2.2008 Ingelvac CircoFLEX Porcine circovirus type 2 ORF2 protein minimum RP 1,0, maximum RP 3,75 Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/07/079/001-004 Suspension for injection QI09AA07 15.2.2008

— 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 5.2.2008 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-002 7.2.2008 7.2.2008 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/06/061/001-004 11.2.2008 7.2.2008 Advocate Bayer HealthCare AG D-51368 Leverkusen EU/2/03/039/001-030 11.2.2008

— Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004)

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 6.2.2008 Advasure Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/00/025/001-004 8.2.2008

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.