EN Official Journal of the European Union C 321/13

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2006 to 30 November 2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2006/C 321/06)

— 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 20.11.2006 BYETTA exenatide Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/06/362/001-004 Solution for injection A10BX04 22.11.2006 20.11.2006 Sprycel dasatinib Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/06/363/001-009 Film-coated tablet L01XX 22.11.2006

— 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 7.11.2006 Exubera PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/05/327/001-018 9.11.2006 7.11.2006 Humira Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 9.11.2006 7.11.2006 Trudexa Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-010 9.11.2006 14.11.2006 Humalog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/015-017 EU/1/96/007/026-028 16.11.2006 14.11.2006 Zevalin Schering AG Müllerstrasse 170-178 D-13342 Berlin EU/1/03/264/001 16.11.2006 20.11.2006 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 22.11.2006 20.11.2006 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 22.11.2006 20.11.2006 Yttriga QSA Global GmbH Gieselweg 1 D-38110 Braunschweig EU/1/05/322/001 22.11.2006 20.11.2006 Liprolog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/005-007 EU/1/01/195/013-015 22.11.2006 20.11.2006 Protopic Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/201/001-006 22.11.2006 20.11.2006 Protopy Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/202/001-006 22.11.2006 20.11.2006 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United-Kingdom EU/1/96/016/001 EU/1/96/016/003 22.11.2006 22.11.2006 TRIZIVIR Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/002-003 24.11.2006 22.11.2006 Evista Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/98/073/001-004 24.11.2006 22.11.2006 Optruma Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/98/074/001-004 24.11.2006 22.11.2006 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City, AL7 1TW United Kingdom EU/1/02/221/01-010 24.11.2006 22.11.2006 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 24.11.2006 22.11.2006 Invirase Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/026/001-002 24.11.2006 22.11.2006 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 24.11.2006 22.11.2006 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 24.11.2006 22.11.2006 AVANDIA SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/00/137/002-018 24.11.2006 24.11.2006 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/283/001-007 28.11.2006 24.11.2006 Avaglim SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/06/349/001-008 28.11.2006 24.11.2006 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/010-011 28.11.2006 24.11.2006 Pedea Orphan Europe SARL Immeuble ‘Le Guillaumet’ F-92046 Paris-La-Défense EU/1/04/284/001 28.11.2006 24.11.2006 Aptivus Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 28.11.2006 24.11.2006 Replagal Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/01/189/001-006 28.11.2006 24.11.2006 Levitra Bayer AG D-51368 Leverkusen, EU/1/03/248/001-012 28.11.2006 24.11.2006 Vivanza Bayer AG D-51368 Leverkusen EU/1/03/249/001-012 28.11.2006 24.11.2006 Xeristar Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-008 28.11.2006 24.11.2006 Cymbalta Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-008 28.11.2006 28.11.2006 Ziagen Glaxo Group Ltd, Greenford Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 1.12.2006 28.11.2006 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 1.12.2006 28.11.2006 Tysabri Elan Pharma International Ltd. Monksland Athlone County Westmeath Ireland EU/1/06/346/001 4.12.2006 28.11.2006 Ebixa H. Lundbeck A/S, Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-015 1.12.2006 28.11.2006 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/001-011 1.12.2006 28.11.2006 Kepivance Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/05/314/001 1.12.2006 28.11.2006 Nespo Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano EU/1/01/184/001-068 1.12.2006 28.11.2006 Kivexa Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/04/298/001-002 1.12.2006 28.11.2006 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/280/001-008 1.12.2006 28.11.2006 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/001-036 1.12.2006 29.11.2006 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead, Berkshire, SL6 0PH United Kingdom EU/1/99/126/001-018 1.12.2006 29.11.2006 Aldara Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex EU/1/98/080/001 1.12.2006 29.11.2006 Foscan Biolitec pharma Ltd United Drug House Magna Drive Dublin 24 Ireland EU/1/01/197/001-002 1.12.2006 29.11.2006 Emselex Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/04/294/001-028 1.12.2006 29.11.2006 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-068 1.12.2006

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

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 14.11.2006 Monotard Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/235/001-004 16.11.2006 14.11.2006 Ultratard Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/02/236/001-004 16.11.2006

— 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 14.11.2006 Yarvitan Mitratapide Janssen Animal Health B.V.B.A. Turnhoutseweg, 30 B-2340 Beerse EU/2/06/063/001-003 Oral solution QA08AB90 16.11.2006

— 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 20.11.2006 Virbagen Omega VIRBAC S.A. 1ere Avenue 2065 m L.I.D. F-06516 Carros EU/2/01/030/001-004 22.11.2006

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.