EN Official Journal of the European Union C 245/15

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 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 245/03)

— 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 28.8.2008 INTELENCE Etravirine Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/08/468/001 Tablet (Non applicable) 1.9.2008 29.8.2008 Vimpat Lacosamide UCB S.A. Allée de la Recherche, 60/Researchdreef, 60 B-1070 Bruxelles/B-1070 Brussel EU/1/08/470/001-013 Film-coated tablet N03AX18 2.9.2008 EU/1/08/470/014-015 Syrup EU/1/08/470/016 Solution for infusion

— 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 4.8.2008 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland EU/1/05/331/001-037 6.8.2008 8.8.2008 Champix Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/360/001-012 12.8.2008 8.8.2008 Vectibix Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/07/423/001-003 12.8.2008 8.8.2008 Infanrix hexa GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/152/001-018 12.8.2008 8.8.2008 Evista Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/98/073/001-004 12.8.2008 8.8.2008 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 12.8.2008 11.8.2008 Optruma Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/98/074/001-004 13.8.2008 13.8.2008 Silapo STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel EU/1/07/432/001-022 15.8.2008 13.8.2008 Retacrit HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland EU/1/07/431/001-019 15.8.2008 13.8.2008 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 15.8.2008 13.8.2008 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 15.8.2008 13.8.2008 Infanrix penta GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/153/001-010 18.8.2008 13.8.2008 Cervarix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/07/419/001-009 18.8.2008 22.8.2008 Evista DAIICHI SANKYO EUROPE GmbH Zielstattstrasse 48 D-81379 München EU/1/98/073/001-004 26.8.2008 Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland 22.8.2008 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-006 26.8.2008 22.8.2008 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/343/001-007 26.8.2008 22.8.2008 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-006 26.8.2008 22.8.2008 Fosavance Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/05/310/001-009 26.8.2008 22.8.2008 Zalasta KRKA d.d. Šmarješka cesta 6 SLO-8501 Novo mesto EU/1/07/415/001-056 26.8.2008 22.8.2008 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-035 26.8.2008 22.8.2008 Revlimid Celgene Europe Limited Morgan House Madeira Walk Windsor Berkshire SL4 1EP United Kingdom EU/1/07/391/001-004 26.8.2008 25.8.2008 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/001-020 EU/1/04/276/024-036 27.8.2008 25.8.2008 TARGRETIN Eisai Limited 3 Shortlands London W6 8EE United Kingdom EU/1/01/178/001 27.8.2008 25.8.2008 Emselex Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/04/294/001-028 27.8.2008 25.8.2008 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 27.8.2008 25.8.2008 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 27.8.2008 25.8.2008 Revatio Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/05/318/001 27.8.2008 25.8.2008 Prialt Eisai Limited 3 Shortlands London W6 8EE United Kingdom EU/1/04/302/001-004 27.8.2008 25.8.2008 NovoSeven Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/96/006/001-006 27.8.2008 26.8.2008 Viagra Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom EU/1/98/077/002-004 EU/1/98/077/006-008 EU/1/98/077/010-019 28.8.2008 28.8.2008 Rasilez Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/405/001-020 1.9.2008 28.8.2008 Tekturna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/408/001-020 1.9.2008 28.8.2008 Raptiva Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom EU/1/04/291/001-003 1.9.2008 28.8.2008 ISENTRESS Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/07/436/001-002 1.9.2008 28.8.2008 Enviage Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/406/001-020 1.9.2008 28.8.2008 Sprimeo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/407/001-020 1.9.2008 28.8.2008 Riprazo Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/07/409/001-020 1.9.2008 29.8.2008 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 2.9.2008 29.8.2008 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-073 2.9.2008 29.8.2008 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-018 1.9.2008 29.8.2008 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001-002 2.9.2009 29.8.2008 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 2.9.2009 29.8.2008 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 2.9.2009 29.8.2008 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 2.9.2009 29.8.2008 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland EU/1/05/331/038-055 2.9.2009 29.8.2008 Neupro Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland EU/1/05/331/001-055 2.9.2009

— 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 22.8.2008 Protopy Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/202/001-006 26.8.2008 28.8.2008 Quintanrix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/04/301/001-005 1.9.2008

— 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 13.8.2008 Dexdomitor Orion Corporation Orionintie 1 FI-02200 Espoo EU/2/02/033/001-002 15.8.2008 22.8.2008 Suvaxyn Aujeszky Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland EU/2/98/009/001-006 26.8.2008 25.8.2008 Zubrin Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/2/00/028/002-008 27.8.2008 25.8.2008 Circovac Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/07/075/001-004 27.8.2008 25.8.2008 Profender Bayer HealthCare AG D-51368 Leverkusen EU/2/05/054/018-031 27.8.2008

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.