EN Official Journal of the European Union C 144/5

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 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 144/06)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 2.5.2007 Focetria A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 I-53100 Siena EU/1/07/385/001-004 Suspension for injection J07BB02 4.5.2007 21.5.2007 ORENCIA abatacept Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/07/389/001-003 Powder for concentrate for solution for infusion L04AA24 23.5.2007 24.5.2007 Altargo retapamulin Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/07/390/001-004 Ointment D06AX13 29.5.2007

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 22.5.2007 Mycograb NeuTec Pharma plc Central Manchester & Manchester Children's Hospital NHS Trust Oxford Rd Manchester M13 9WL United Kingdom — 29.5.2007

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 2.5.2007 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-073 4.5.2007 2.5.2007 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/001-015 4.5.2007 2.5.2007 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/97/047/001-003 4.5.2007 2.5.2007 Vfend Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/02/212/001-026 4.5.2007 2.5.2007 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-073 4.5.2007 2.5.2007 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 4.5.2007 2.5.2007 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 4.5.2007 2.5.2007 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 4.5.2007 2.5.2007 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001 4.5.2007 2.5.2007 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland EU/1/01/179/001 4.5.2007 2.5.2007 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/99/110/001-009 4.5.2007 2.5.2007 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-011 4.5.2007 3.5.2007 Protopy Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/202/001-006 7.5.2007 3.5.2007 Crixivan Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 8.5.2007 3.5.2007 Protopic Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/201/001-006 7.5.2007 3.5.2007 Infanrix Hexa GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/152/001-018 7.5.2007 3.5.2007 Infanrix Penta GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/00/153/001-010 7.5.2007 3.5.2007 Humalog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-030 7.5.2007 11.5.2007 Prialt Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/04/302/001-004 15.5.2007 14.5.2007 PritorPlus Bayer HealthCare AG D-51368 Leverkusen EU/1/02/215/001-014 16.5.2007 14.5.2007 Hepsera Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/03/251/001-002 16.5.2007 14.5.2007 Humira Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 16.5.2007 14.5.2007 Trudexa Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-010 16.5.2007 15.5.2007 Omnitrope Sandoz GmbH Biochemiestraße 10 A-Kundl 6250 EU/1/06/332/001-006 18.5.2007 15.5.2007 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/070/001a–006a EU/1/98/070/001b-006b 17.5.2007 15.5.2007 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/069/001a-006a EU/1/98/069/001b-006b 21.5.2007 15.5.2007 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 17.5.2007 22.5.2007 Thelin Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom EU/1/06/353/001-005 25.5.2007 22.5.2007 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 25.5.2007 22.5.2007 Teslascan GE Healthcare AS Nycoveien 1-2 P.O. Box 4220 Nydalen N-0401 Oslo EU/1/97/040/001-002 25.5.2007 22.5.2007 Opatanol Alcon Laboratories (UK) Ltd. Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/02/217/001-002 24.5.2007 30.5.2007 Xolair Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/319/001-004 1.6.2007 30.5.2007 Caelyx Schering Plough Europe rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/96/011/001-004 1.6.2007 30.5.2007 Ventavis Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/03/255/001-005 1.6.2007 30.5.2007 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 1.6.2007 30.5.2007 LeukoScan Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt EU/1/97/032/001 1.6.2007 30.5.2007 Ziagen Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 1.6.2007 30.5.2007 Kivexa Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/298/001-002 1.6.2007 30.5.2007 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 1.6.2007 30.5.2007 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 1.6.2007 30.5.2007 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-010 1.6.2007 31.5.2007 Ketek Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 4.6.2007 31.5.2007 Levviax Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 5.6.2007

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 14.5.2007 Nobilis Influenza H7N1 Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test. Intervet International B.V. EU/2/07/073/001-004 Emulsion for injection QI01AA23 16.5.2007

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 15.5.2007 METACAM Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/97/004/007-008 EU/2/97/004/014-015 EU/2/97/004/027-028 18.5.2007

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 of 30 April 2004, page 1