EN Official Journal of the European Union C 188/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 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 188/04)

— 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 10.6.2008 Tyverb Lapatinib Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/07/440/001-002 Film-coated tablet L01XE07 12.6.2008

— 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 2.6.2008 Xyrem UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom EU/1/05/312/001 4.6.2008 2.6.2008 Dafiro Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/371/001-033 4.6.2008 2.6.2008 Copalia Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/372/001-033 4.6.2008 3.6.2008 Exforge Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/370/001-033 5.6.2008 3.6.2008 Imprida Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/373/001-003 5.6.2008 4.6.2008 Evoltra Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey GU15 3PU United Kingdom EU/1/06/334/001-004 6.6.2008 Genzyme Europe BV Gooimeer 10 1411 DD Naarden Nederland 6.6.2008 Vaniqa Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/01/173/001-003 10.6.2008 Laboratorios Almirall S.A. Ronda General Mitre, no 151 E-08022 Barcelona 11.6.2008 10.6.2008 Olanzapine Neopharma Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF United Kingdom EU/1/07/426/001-011 12.6.2008 10.6.2008 Imprida Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/373/001-033 12.6.2008 10.6.2008 Irbesartan BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/375/001-033 12.6.2008 10.6.2008 Exforge Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/370/001-033 12.6.2008 10.6.2008 Copalia Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/372/001-033 12.6.2008 10.6.2008 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/97/046/001-039 12.6.2008 10.6.2008 Olanzapine Teva Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland EU/1/07/427/001-057 12.6.2008 10.6.2008 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/97/049/001-039 12.6.2008 10.6.2008 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/98/085/001-034 12.6.2008 10.6.2008 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/001-034 12.6.2008 10.6.2008 Irbesartan HCT BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/369/001-028 12.6.2008 10.6.2008 Irbesartan HCT Winthrop Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/06/377/001-028 12.6.2008 10.6.2008 Dafiro Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/371/001-033 12.6.2008 11.6.2008 Irbesartan Winthrop Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/06/376/001-033 13.6.2008 12.6.2008 Optison GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo EU/1/98/065/001-002 16.6.2008 17.6.2008 Xenical Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/071/001-006 19.6.2008 18.6.2008 Insuman - Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/97/030/028-139 20.6.2008 18.6.2008 Novomix Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/009-022 20.6.2008 18.6.2008 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/06/368/001-057 20.6.2008 18.6.2008 Norvir Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 20.6.2008 18.6.2008 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 20.6.2008 18.6.2008 Atripla Bristol-Myers Squibb and Gilead Sciences Limited Unit 13 Stillorgan Industrial Park Blackrock Co. Dublin Ireland EU/1/07/430/001 23.6.2008 18.6.2008 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-004 20.6.2008 18.6.2008 Parareg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 20.6.2008 18.6.2008 Agenerase Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 20.6.2008 18.6.2008 Renagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/99/123/005-012 20.6.2008 19.6.2008 Twinrix Paediatric GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/97/029/001-010 23.6.2008 19.6.2008 Rotarix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/05/330/001-004 23.6.2008 19.6.2008 Cholestagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/268/001-004 23.6.2008 19.6.2008 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/069/001a-007b, 008-010 23.6.2008 19.6.2008 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/98/070/001a-007b, 008-010 23.6.2008 19.6.2008 InductOs Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/02/226/001 23.6.2008 19.6.2008 Paxene Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom EU/1/99/113/001-004 24.6.2008 19.6.2008 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 23.6.2008 19.6.2008 Twinrix Adult GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/96/020/001-009 23.6.2008 20.6.2008 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 24.6.2008 20.6.2008 Viracept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/054/001 EU/1/97/054/004-005 24.6.2008 20.6.2008 Azopt Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/00/129/001-003 24.6.2008 20.6.2008 Tysabri Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland EU/1/06/346/001 26.6.2008 20.6.2008 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/03/267/001-009 24.6.2008 20.6.2008 Evra Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse EU/1/02/223/001-003 24.6.2008 20.6.2008 Crixivan Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/96/024/001-005 EU/1/96/024/007-08 EU/1/96/024/010 24.6.2008 20.6.2008 Apidra Sanofi-Aventis Deutschland GmbH Brueningstrasse, 50 D-65926 Frankfurt am Main EU/1/04/285/001-036 24.6.2008 20.6.2008 Prezista Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse EU/1/06/380/001 24.6.2008 20.6.2008 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/05/323/001-013 24.6.2008 20.6.2008 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/036 24.6.2008 20.6.2008 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/337/001-013 24.6.2008 20.6.2008 Puregon Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss Nederland EU/1/96/008/001-041 24.6.2008 20.6.2008 Kaletra Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-006 24.6.2008 20.6.2008 Vistide Pfizer Enterprises SARL 51, Avenue Kennedy-Rond Point du Kirchberg L-1855 Luxembourg EU/1/97/037/001- 24.6.2008 20.6.2008 Raptiva Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/04/291/001-002 24.6.2008 20.6.2008 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-008 24.6.2008 20.6.2008 Rapilysin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/033/002 24.6.2008 Actavis Group PTC ehf. Reykjavikurvegi 76-78 IS-220 Hafnarfjordur 24.6.2008 20.6.2008 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom EU/1/97/033/002-004 24.6.2008 20.6.2008 Vfend Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/212/001-026 24.6.2008 20.6.2008 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 24.6.2008 23.6.2008 Humira Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 25.6.2008 25.6.2008 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/133/001-007 27.6.2008 25.6.2008 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/343/001-007 27.6.2008 25.6.2008 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/001-037 27.6.2008 25.6.2008 Temodal Schering Plough Europe Rue de Stalle 73/Stallestraat 73 B-1180 Bruxelles/B-1180 Brussel EU/1/98/096/001-012 27.6.2008 25.6.2008 Elaprase Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/06/365/001-003 27.6.2008 27.6.2008 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn EU/1/07/412/001-020 1.7.2008 30.6.2008 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom EU/1/06/363/001-009 2.7.2008

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 25.6.2008 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/06/336/001 27.6.2008

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004) (applicable with effect from 1 January 2009)

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 10.6.2008 Zenapax Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/99/098/001-002 12.6.2008

— Issuing of a marketing authorization (Article 38 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 23.6.2008 Posatex Orbifloxacin, Mometasone furoate, Posaconazole S-P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/2/08/081/001-003 Ear drops, suspension QS02CA91 25.6.2008 25.6.2008 EQUIOXX Firocoxib MERIAL 29, avenue Tony Garnier F-69007 Lyon EU/2/08/083/001 Oral paste QM01AH90 27.6.2008

— 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 3.6.2008 Convenia Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/06/059/001 5.6.2008 4.6.2008 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/007 6.6.2008 13.6.2008 Gonazon Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/03/040/001-002 17.6.2008 20.6.2008 DRAXXIN Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/03/041/001-005 24.6.2008 23.6.2008 Nobilis Influenza H7N1 Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/07/073/001-004 25.6.2008

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.