EN Official Journal of the European Union C 251/10

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 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 251/09)

— 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 7.9.2007 Gliolan 5-aminolevulinic acid hydrochloride Medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 D-20354 Hamburg EU/1/07/413/001-003 Powder for oral solution L01XD04 12.9.2007 17.9.2007 Yondelis Trabectedin Pharma Mar, S.A. Avda. de los Reyes 1 Polígono Industrial La Mina E-28770 Colmenar Viejo (Madrid) EU/1/07/417/001-002 Powder for concentrate for solution for infusion L01CX01 20.9.2007 18.9.2007 CELSENTRI Maraviroc Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/418/001-010 Film — coated tablet J05AX09 20.9.2007 20.9.2007 ECALTA Anidulafungin Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/07/416/001 Powder and solvent for concentrate for solution for infusion JO2AX06 24.9.2007 20.9.2007 Cervarix Human Papilloma Virus-16 and Human Papilloma Virus 18 L1 proteins GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 B-1330 Rixensart EU/1/07/419/001-009 Suspension for injection J07BM02 24.9.2007 26.9.2007 Galvus Vildagliptin Novartis Europharm Limited Wimblehurst Road Orsham West Sussex RH12 5AB United Kingdom EU/1/07/414/001-017 Tablet A10BH02 28.9.2007 27.9.2007 Zalasta Olanzapine KRKA, d.d. Novo mesto Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/07/415/001-031 Tablet N05AH03 1.10.2007 EU/1/07/415/032-056 Orodispersible 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 3.9.2007 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-020 5.9.2007 3.9.2007 Quixidar Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/001-020 5.9.2007 3.9.2007 TRIZIVIR Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/002-003 5.9.2007 3.9.2007 Combivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/98/058/001-002 5.9.2007 3.9.2007 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 6.9.2007 3.9.2007 Novoseven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-003 6.9.2007 7.9.2007 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 11.9.2007 7.9.2007 Evra Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/02/223/001-003 11.9.2007 7.9.2007 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 11.9.2007 7.9.2007 Ambirix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89 B-1330 Rixensart EU/1/02/224/001-005 11.9.2007 13.9.2007 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-002 18.9.2007 13.9.2007 Telzir Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 18.9.2007 17.9.2007 Cerezyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/97/053/001-005 20.9.2007 17.9.2007 Exelon Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/066/019-026 20.9.2007 17.9.2007 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/051/001-012 20.9.2007 17.9.2007 Cialis Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom EU/1/02/237/001-008 28.9.2007 18.9.2007 Actraphane Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/229/001-033 20.9.2007 18.9.2007 Protaphane Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/234/001-017 20.9.2007 18.9.2007 Insulatard Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/233/001-015 20.9.2007 18.9.2007 Xyrem UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom EU/1/05/312/001 20.9.2007 18.9.2007 TOVIAZ Schwarz Pharma AG Alfred-Nobel Straße 10 D-40789 Monheim EU/1/07/386/001-010 20.9.2007 Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom 20.9.2007 18.9.2007 Velosulin Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/232/001-003 20.9.2007 18.9.2007 Actrapid Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/230/001-017 20.9.2007 18.9.2007 Mixtard Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/231/001-037 20.9.2007 19.9.2007 Omnitrope Sandoz GmbH Biochemiestraße 10 A-6250 Kundl EU/1/06/332/007-009 21.9.2007 19.9.2007 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/003-004 21.9.2007 20.9.2007 Somavert Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/240/001-004 24.9.2007 25.9.2007 NeuroBloc Solstice Neurosciences Ltd Fitzwilton House Wilton Place Dublin 2 Ireland EU/1/00/166/001-003 27.9.2007 Eisai Limited 3, Shortlands London W6 8EE United Kingdom 27.9.2007 25.9.2007 Prometax Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/092/019-026 27.9.2007 25.9.2007 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/050/001-012 27.9.2007

— 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 3.9.2007 Oxyblobin Biopure Netherlands B.V. Parnassustoren Locatellikade 1 1076 AZ Amsterdam Nederland EU/2/99/015/001 5.9.2007 4.9.2007 Econor Novartis Animal Health Austria GmbH Biochemiestraße 10 A-6250 Kundl EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-024 6.9.2007 7.9.2007 Cortavance VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros EU/2/06/069/001 11.9.2007 7.9.2007 Meloxidyl CEVA SANTE ANIMALE Z.I. la Ballastière F-33500 Libourne EU/2/06/070/001-003 11.9.2007 25.9.2007 Nobivac Bb Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/02/034/001 27.9.2007

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.