EN Official Journal of the European Union C 203/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2007 to 31 July 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 203/03)

— 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 20.7.2007 MIRCERA methoxy polyethylene glycol-epoetin beta Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/07/400/001-016 Solution for injection B03XA03 25.7.2007 23.7.2007 Orlistat GSK Orlistat Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom EU/1/07/401/001-006 Capsule, hard A08AB01 25.7.2007 23.7.2007 OptiMARK Gadoversetamide Tyco Healthcare Deutschland GmbH Gewerbepark 1 D-93333 Neustadt/Donau EU/1/07/398/001-014 Solution for injection V08CA06 25.7.2007 30.7.2007 Aerinaze desloratadine/pseudoephedrine sulphate SP Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/07/399/001-006 Release tablet R06A X27 1.8.2007

— 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 2.7.2007 Cellcept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/005/001-006 5.7.2007 2.7.2007 Apidra Sanofi-Aventis Deutschland GmbH Brueningstraße 50 D-65926 Frankfurt am Main EU/1/04/285/001-036 5.7.2007 2.7.2007 Exjade Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/06/356/001-006 5.7.2007 2.7.2007 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 5.7.2007 2.7.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 5.7.2007 2.7.2007 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-011 5.7.2007 2.7.2007 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/99/110/001-009 5.7.2007 2.7.2007 Naglazyme BioMarin Europe Limited Axtell House 23-24 Warwick Street London W1B 5NQ United Kingdom EU/1/05/324/001 5.7.2007 3.7.2007 Ammonaps Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/99/120/003-004 5.7.2007 9.7.2007 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 11.7.2007 9.7.2007 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom EU/1/97/033/002-004 11.7.2007 9.7.2007 Rebetol Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/99/107/001-005 11.7.2007 9.7.2007 IntronA Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/99/127/001-044 11.7.2007 9.7.2007 Simulect Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/084/001-002 11.7.2007 9.7.2007 Vfend Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/02/212/001-026 11.7.2007 16.7.2007 Neupopeg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/02/228/001-003 18.7.2007 16.7.2007 Neulasta Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/02/227/001-003 18.7.2007 20.7.2007 Xigris Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/02/225/001-002 27.7.2007 20.7.2007 Optison GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo EU/1/98/065/001-002 26.7.2007 20.7.2007 Prialt Eisai Limited, 3 Shortlands London W6 8EE United Kingdom EU/1/04/302/001-004 25.7.2007 20.7.2007 REYATAZ Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/03/267/001-007 25.7.2007 23.7.2007 Trisenox Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort, Cedex EU/1/02/204/001 25.7.2007 24.7.2007 RotaTeq Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/348/001-002 26.7.2007 24.7.2007 Zostavax Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/341/001-013 26.7.2007 24.7.2007 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 26.7.2007 24.7.2007 Telzir Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 26.7.2007 24.7.2007 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/06/380/001 26.7.2007 24.7.2007 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 26.7.2007 24.7.2007 Twinrix Adult GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/96/020/001-009 26.7.2007 24.7.2007 Onsenal Pharmacia-Pfizer EEIG Ramsgate Road Sandwich CT13 9NJ United Kingdom EU/1/03/259/001-006 27.7.2007 24.7.2007 Helixate NexGen Bayer HealthCare AG D-51368 Leverkusen EU/1/00/144/001-003 27.7.2007 24.7.2007 KOGENATE Bayer Bayer HealthCare AG D-51368 Leverkusen EU/1/00/143/001-009 27.7.2007 24.7.2007 Preotact Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde EU/1/06/339/001-002 27.7.2007 24.7.2007 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 27.7.2007 24.7.2007 Gardasil Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-017 27.7.2007 24.7.2007 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-017 27.7.2007 24.7.2007 ReFacto Wyeth Europa Ltd untercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/103/001-004 27.7.2007 24.7.2007 Advate Baxter AG Industriesstrasse 67 A-1220 Vienna EU/1/03/271/001-004 27.7.2007 25.7.2007 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-012 30.7.2007 25.7.2007 Kaletra Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-005 30.7.2007 25.7.2007 Temodal Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/98/096/001-012 30.7.2007 25.7.2007 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/308/001-002 30.7.2007 25.7.2007 Agenerase Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/148/001-004 30.7.2007 30.7.2007 BeneFix Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/97/047/004-007 1.8.2007 30.7.2007 Velcade Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/04/274/001 1.8.2007 30.7.2007 Suboxone Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/06/359/001-004 1.8.2007 30.7.2007 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-007 1.8.2007 30.7.2007 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/001-011 2.8.2007

— 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 9.7.2007 Trudexa Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-010 11.7.2007

— 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 10.7.2007 Suprelorin Deslorelin acetate Cyton Biosciences Ltd Hyland Mews 21 High Street Clifton Bristol BS8 2YF United Kingdom EU/2/07/072/001-002 Implant QH01CA93 12.7.2007

— 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 16.7.2007 ProteqFlu Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/03/037/005 18.7.2007 16.7.2007 Advocate Bayer HealthCare AG D-51368 Leverkusen EU/2/03/039/019-030 18.7.2007 24.7.2007 ProMeris Duo Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland EU/2/06/065/001-010 26.7.2007

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.