EN Official Journal of the European Union C 236/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006

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

(2006/C 236/02)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 10.8.2006 Thelin sitaxentan sodium Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom EU/1/06/353/001-005 film coated tablet Non applicable 11.8.2006 28.8.2006 Exjade deferasirox Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/356/001-006 Dispersible tablet V03AC03 31.8.2006

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 4.8.2006 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron F-92165 Antony Cedex EU/1/95/002/001-002 8.8.2006 4.8.2006 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-003 8.8.2006 4.8.2006 Hepsera Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/03/251/001 8.8.2006 4.8.2006 HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 8.8.2006 4.8.2006 HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 8.8.2006 4.8.2006 Tasmar Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford lane Basingstoke RG24 8WD United Kingdom EU/1/97/044/001-008 8.8.2006 4.8.2006 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/012 8.8.2006 4.8.2006 Mirapexin Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/97/051/001-006 EU/1/97/051009-012 8.8.2006 4.8.2006 InductOs Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/02/226/001 8.8.2006 7.8.2006 Levviax Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 9.8.2006 7.8.2006 Ketek Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 9.8.2006 7.8.2006 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-029 9.8.2006 7.8.2006 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/001-008 9.8.2006 7.8.2006 Keppra UCB S.A. Allée de la recherche, 60 B-1070 Bruxelles Researchdreef 60 B-1070 Brussel EU/1/00/146/001-030 9.8.2006 7.8.2006 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 9.8.2006 7.8.2006 Zenapax Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/99/098/001-002 9.8.2006 7.8.2006 KOGENATE Bayer Bayer HealthCare AG D-51368 Leverkusen EU/1/00/143/001-009 9.8.2006 7.8.2006 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 9.8.2006 7.8.2006 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 9.8.2006 7.8.2006 Optison Amersham Health AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo EU/1/98/065/001-002 9.8.2006 10.8.2006 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 14.8.2006 10.8.2006 Rapilysin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/018/001 14.8.206 21.8.2006 HBVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 23.8.2006 21.8.2006 Ziagen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 23.8.2006 21.8.2006 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-003 23.8.2006 28.8.2006 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/03/265/001-006 31.8.2006 28.8.2006 Aptivus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 31.8.2006 28.8.2006 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 B-1330 Rixensart EU/1/97/029/001-010 31.8.2006 28.8.2006 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 B-1330 Rixensart EU/1/96/020/001-009 31.8.2006 28.8.2006 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/03/266/001-006 31.8.2006 28.8.2006 Truvada Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 31.8.2006 28.8.2006 Vfend Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/02/212/001-026 31.8.2006 28.8.2006 Inductos Wyeth Europa Ltd. Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/02/226/001 31.8.2006 28.8.2006 Hepsera Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/03/251/001 31.8.2006 28.8.2006 Orfadin Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/04/303/001-003 31.8.2006 28.8.2006 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/085/023-028 31.8.2006 28.8.2006 Revatio Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/318/001 1.9.2006 28.8.2006 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/023-028 31.8.2006

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 10.8.2006 Equilis Prequenza Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/05/056/003-004 14.8.2006 10.8.2006 Equilis Prequenza te Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/05/057/003-004 14.8.2006 21.8.2006 Vaxxitek HVT+ IBD Merial 29, avenue Tony Garnier F-69007 Lyon EU/2/02/032/001 23.8.2006 21.8.2006 Naxcel Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/2/05/053/002 23.8.2006

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 of 30.4.2004, p. 1.