EN Official Journal of the European Union C 288/7

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 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 288/04)

— 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 2.10.2007 ADROVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/364/001-009 4.10.2007 2.10.2007 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 4.10.2007 3.10.2007 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/308/001-002 5.10.2007 4.10.2007 Thyrogen Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/99/122/001-002 8.10.2007 4.10.2007 FOSAVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/05/310/001-009 11.10.2007 9.10.2007 Arixtra Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/001-008 11.10.2007 9.10.2007 AZILECT Teva Pharma GmbH Kandelstraße 10 D-79199 Kirchzarten EU/1/04/304/001-007 11.10.2007 9.10.2007 Quixidar Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/001-008 11.10.2007 9.10.2007 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 11.10.2007 9.10.2007 Myozyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/06/333/001-003 11.10.2007 15.10.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 19.10.2007 15.10.2007 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/004-006 18.10.2007 15.10.2007 Ionsys Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/05/326/001 18.10.2007 15.10.2007 Foscan Biolitec Pharma Ltd United Drug House Magna Drive Dublin 24 Ireland EU/1/01/197/003-005 18.10.2007 15.10.2007 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/013-015 18.10.2007 15.10.2007 Elaprase Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/06/365/001-003 18.10.2007 15.10.2007 Zevalin Bayer Schering Pharma AG D-13342 Berlin EU/1/03/264/001 18.10.2007 15.10.2007 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/085/001-034 18.10.2007 15.10.2007 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/001-034 23.10.2007 18.10.2007 Zenapax Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/99/098/001-002 23.10.2007 18.10.2007 Cialis Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/237/001-008 22.10.2007 Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom 24.10.2007 19.10.2007 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/176/001-006 23.10.2007 19.10.2007 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 23.10.2007 19.10.2007 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/001 EU/1/97/054/003-005 23.10.2007 19.10.2007 Keppra UCB Pharma SA Allée de la Recherche, 60/ Researchdreef, 60 B-1070 Bruxelles/Brussel EU/1/00/146/001-030 23.10.2007 19.10.2007 Cellcept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/005/001-006 23.10.2007 19.10.2007 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 23.10.2007 22.10.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 24.10.2007 22.10.2007 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/188/001-006 24.10.2007 22.10.2007 Zevalin Bayer Schering Pharma AG D-13342 Berlin EU/1/03/264/001 24.10.2007 23.10.2007 ACOMPLIA Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/344/001-011 25.10.2007 23.10.2007 Tritanrix HepB GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/96/014/001-003 25.10.2007 23.10.2007 Vasovist Bayer Schering Pharma AG D-13342 Berlin EU/1/05/313/001-009 25.10.2007 23.10.2007 Telzir Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 25.10.2007 23.10.2007 Zimulti Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/06/345/001-011 25.10.2007 23.10.2007 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/251/001-002 25.10.2007 24.10.2007 Hycamtin SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/96/027/001 EU/1/96/027/003-005 26.10.2007 24.10.2007 Competact Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/06/354/001-009 26.10.2007 24.10.2007 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-004 26.10.2007 24.10.2007 Avastin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/04/300/001-002 26.10.2007 24.10.2007 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/06/336/001 26.10.2007 24.10.2007 FOSAVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/05/310/001-009 26.10.2007 24.10.2007 SUTENT Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/347/001-006 26.10.2007 24.10.2007 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-005 26.10.2007 29.10.2007 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/033-035 31.10.2007 29.10.2007 Zonegran Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/04/307/001-013 31.10.2007 29.10.2007 Luminity Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185/ Terhulpsesteenweg, 185 B-1170 Bruxelles/Brussel EU/1/06/361/001-002 31.10.2007 29.10.2007 Nexavar Bayer HealthCare AG D-51368 Leverkusen EU/1/06/342/001 31.10.2007 30.10.2007 Noxafil SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/05/320/001 5.11.2007 30.10.2007 Posaconazole SP SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/05/321/001 5.11.2007 30.10.2007 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 1.11.2007 30.10.2007 Helixate NexGen Bayer HealthCare AG D-51368 Leverkusen EU/1/00/144/001-003 2.11.2007 30.10.2007 KOGENATE Bayer Bayer HealthCare AG D-51368 Leverkusen EU/1/00/143/001-009 2.11.2007 30.10.2007 PegIntron Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/00/131/001-050 5.11.2007 30.10.2007 ViraferonPeg Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/00/132/001-050 5.11.2007 30.10.2007 Epivir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/96/015/001-005 1.11.2007 30.10.2007 Rebetol Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/99/107/001-005 5.11.2007 30.10.2007 Nonafact Sanquin Plesmanlaan 125 1066 CX Amsterdam Nederland EU/1/01/186/001-002 1.11.2007 31.10.2007 Xyrem UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom EU/1/05/312/001 7.11.2007 31.10.2007 Ammonaps Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/99/120/001-004 7.11.2007 31.10.2007 Aldurazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/253/001-003 7.11.2007 31.10.2007 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 7.11.2007 31.10.2007 ADROVANCE Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/364/001-009 7.11.2007 31.10.2007 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 7.11.2007 31.10.2007 Alimta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/290/001-002 7.11.2007 31.10.2007 BYETTA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/06/362/001-004 7.11.2007

— Lift of suspension of a marketing authorization (Article 20 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 15.10.2007 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/001 EU/1/97/054/003-005 18.10.2007

— 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 9.10.2007 Poulvac FluFend H5N3 RG Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom EU/2/06/060/001-002 11.10.2007 15.10.2007 Purevax FelV Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/00/019/005-007 18.10.2007 29.10.2007 ProteqFlu Te Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/038/005 31.10.2007

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.