EN Official Journal of the European Union C 104/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 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 104/05)

— 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 18.3.2008 Pradaxa dabigatran etexilate mesilate Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/08/442/001-008 Capsule, hard B01AE07 20.3.2008

— 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 3.3.2008 Noxafil SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/05/320/001 5.3.2008 3.3.2008 Posacozanole SP SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/05/321/001 5.3.2008 3.3.2008 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 5.3.2008 3.3.2008 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 5.3.2008 3.3.2008 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-010 5.3.2008 3.3.2008 Avonex Biogen Idec Ltd, 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom EU/1/97/033/002-004 5.3.2008 5.3.2008 MIRCERA Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/07/400/001-016 7.3.2008 5.3.2008 Replagal Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/01/189/001-006 7.3.2008 5.3.2008 Cholestagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/268/001-003 7.3.2008 11.3.2008 Helicobacter Test INFAI INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH Universitätsstrasse 142 D-44799 Bochum EU/1/97/045/001-004 13.3.2008 17.3.2008 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 19.3.2008 17.3.2008 Visudyne Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/00/140/001 19.3.2008 17.3.2008 Cialis Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/237/001-008 19.3.2008 17.3.2008 Levitra Bayer AG D-51368 Leverkusen EU/1/03/248/001-012 19.3.2008 17.3.2008 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 19.3.2008 17.3.2008 Parareg Dompé Biotec S.p.A. Via San Martino, 12, I-20122 Milano EU/1/04/293/001-012 19.3.2008 17.3.2008 Revatio Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/318/001 19.3.2008 17.3.2008 Viagra Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/98/077/002-004 EU/1/98/077/006-008 EU/1/98/077/010-015 19.3.2008 18.3.2008 Omnitrope Sandoz GmbH Biochemiestraße 10 A-6250 Kundl EU/1/06/332/001-009 20.3.2008 18.3.2008 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 20.3.2008 18.3.2008 Hycamtin SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/96/027/006-007 20.3.2008 18.3.2008 Kaletra Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/006 20.3.2008 18.3.2008 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 20.3.2008 18.3.2008 Revlimid Celgene Europe Limited 8 The Square Stockley Park Uxbridge Middlesex UB11 1FW United Kingdom EU/1/07/391/001-004 20.3.2008 19.3.2008 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-020 26.3.2008 27.3.2008 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/02/213/017-023 31.3.2008 27.3.2008 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen EU/1/02/214/011-015 31.3.2008 27.3.2008 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/06/336/001 31.3.2008 27.3.2008 Aptivus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 31.3.2008 27.3.2008 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 31.3.2008 27.3.2008 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-043 31.3.2008 27.3.2008 Xeloda Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/163/001-002 31.3.2008 27.3.2008 Optimark Tyco Healthcare Deutschland GmbH Gewerbepark 1 D-93333 Neustadt/Donau EU/1/07/398/001-014 31.3.2008 31.3.2008 Neoclarityn Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/161/001-067 2.4.2008 31.3.2008 Azomyr Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/157/001-067 2.4.2008 31.3.2008 Xigris Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/225/001-002 2.4.2008 31.3.2008 DuoTrav Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/06/338/001-003 2.4.2008 31.3.2008 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/001-008 2.4.2008 31.3.2008 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/001-036 2.4.2008 31.3.2008 Zonegran Eisai Limited 3 Shortlands London W6 8EE United Kingdom EU/1/04/307/001-013 2.4.2008 31.3.2008 Aerius Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel EU/1/00/160/001-069 2.4.2008 31.3.2008 Tandemact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/366/017-022 2.4.2008

— Withdrawal of a marketing authorization (Article 13 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 11.3.2008 Quixidar Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/001-020 13.3.2008

— 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 5.3.2008 SevoFlo Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/2/02/035/001-007 7.3.2008 11.3.2008 Neocolipor Merial 29 Avenue Tony Garnier F-69007 Lyon EU/2/98/008/001-004 13.3.2008 18.3.2008 Stronghold Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/99/014/001-012 20.3.2008

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.