EN Official Journal of the European Union C 115/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 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 115/03)

— 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 20.4.2007 TOVIAZ fesoterodine Schwarz Pharma AG Alfred-Nobel Straße 10 D-40789 Monheim EU/1/07/386/001-010 Prolonged-release tablets G04B D11 24.4.2007 20.4.2007 Docetaxel Winthrop docetaxel Aventis Pharma S.A. 20, avenue Raymond Aron F-92165 Antony Cedex EU/1/07/384/001-002 Concentrate and solvent for solution for infusion L01CD02 24.4.2007 23.4.2007 Advagraf Tacrolimus Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/07/387/001-008 Prolonged release hard capsules L04AA05 25.4.2007 24.4.2007 Sebivo telbivudine Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/388/001 Film-coated tablet J05AF11 26.4.2007

— 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 2.4.2007 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 4.4.2007 2.4.2007 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-007 4.4.2007 2.4.2007 Xigris Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/225/001-002 4.4.2007 2.4.2007 AZILECT Teva Pharma GmbH Kandelstraße 10 D-79199 Kirchzarten EU/1/04/304/001-007 4.4.2007 2.4.2007 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/013-018 4.4.2007 4.4.2007 Cerezyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/97/053/001-005 11.4.2007 11.4.2007 Panretin Ligand Pharmaceuticals UK Ltd Innovis House 108 High Street Crawley West Sussex RH10 1BB United Kingdom EU/1/00/149/001 13.4.2007 Eisai Ltd 3 Shortlands London W6 8EE United Kingdom 13.4.2007 11.4.2007 TARGRETIN Ligand Pharmaceuticals UK Ltd Innovis House 108 High Street Crawley West Sussex RH10 1BB United Kingdom EU/1/01/178/001 13.4.2007 Eisai Ltd 3 Shortlands London W6 8EE United Kingdom 13.4.2007 13.4.2007 Infanrix Penta GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/153/001-010 17.4.2007 13.4.2007 Infanrix Hexa GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/152/001-018 17.4.2007 13.4.2007 Foscan Biolitec pharma Ltd United Drug House Magna Drive Dublin 24 Ireland EU/1/01/197/001-002 18.4.2007 13.4.2007 Revatio Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/318/001 17.4.2007 13.4.2007 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 17.4.2007 17.4.2007 Cystagon Orphan Europe Immeuble ‘Le Guillaumet’ F-92046 Paris La Défense EU/1/97/039/001-004 19.4.2007 17.4.2007 Teslascan GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo EU/1/97/040/001-002 19.4.2007 17.4.2007 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 19.4.2007 20.4.2007 Quixidar Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/001-020 24.4.2007 20.4.2007 Arixtra Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-020 24.4.2007 20.4.2007 Omnitrope Sandoz GmbH Biochemiestraße 10 A-6250 Kundl EU/1/06/332/004-006 24.4.2007 23.4.2007 Azomyr Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/00/157/035-067 25.4.2007 23.4.2007 Neoclarityn Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/00/161/035-067 25.4.2007 23.4.2007 Aerius Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/00/160/037-069 25.4.2007 23.4.2007 Temodal Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel EU/1/98/096/009-012 25.4.2007 23.4.2007 Dynastat Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/02/209/001-008 25.4.2007 23.4.2007 M-M-RVAXPRO Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/337/001-013 25.4.2007 23.4.2007 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 25.4.2007 23.4.2007 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen EU/1/02/214/001-010 25.4.2007 23.4.2007 MicardisPlus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/02/213/001-016 25.4.2007 24.4.2007 Macugen Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/325/001 26.4.2007 24.4.2007 Kineret Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/203/001-004 26.4.2007 24.4.2007 Truvada Gilead Sciences International Limited Cambridge CB21 6G United Kingdom EU/1/04/305/001 26.4.2007 24.4.2007 Herceptin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/00/145/001 26.4.2007 24.4.2007 NovoMix Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd EU/1/00/142/004-005 EU/1/00/142/009-010 26.4.2007 24.4.2007 Aldara Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex EU/1/98/080/001 26.4.2007 24.4.2007 DaTSCAN GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom EU/1/00/135/001-002 26.4.2007 25.4.2007 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/266/001-006 30.4.2007 25.4.2007 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/265/001-006 30.4.2007 25.4.2007 Xigris Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/225/001-002 27.4.2007 25.4.2007 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 27.4.2007 26.4.2007 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/343/001-005 30.4.2007 26.4.2007 Lysodren Laboratoire HRA Pharma 15, rue Béranger F-75003 Paris EU/1/04/273/001 30.4.2007 26.4.2007 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/360/001-011 30.4.2007 26.4.2007 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/03/267/001-007 30.4.2007

— 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 13.4.2007 Slentrol Dirlotapide Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/2/07/071/001-003 Oral solution QA08AB91 17.4.2007

— 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 20.4.2007 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/97/004/012-013 EU/2/97/004/026 24.4.2007 24.4.2007 Oxyglobin Biopure Netherlands B.V. Drentestraat 24BG 1083HK Amsterdam Nederland EU/2/99/015/001 26.4.2007

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.