EN Official Journal of the European Union C 174/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 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 174/04)

— 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 1.6.2007 Optaflu Influenza vaccine (surface antigen, inactivated, prepared in cell culture) Novartis Vaccines and Diagnostics GmbH & Co. KG Emil-von-Behring-Straße 76 D-35041 Marburg EU/1/07/394/001-006 Suspension for injection in pre-filled syringe J07BB02 5.6.2007 14.6.2007 Revlimid Lenalidomide Celgene Europe Limited 8 The Square Stockley Park Uxbridge UB11 1FW Middlesex United Kingdom EU/1/07/391/001-004 Hard capsule L04AX04 19.6.2007 20.6.2007 Soliris Eculizumab Alexion Europe SAS 54-56, Avenue Hoche F-75008 Paris EU/1/07/393/001 Concentrate for solution for infusion Non applicable 22.6.2007 25.6.2007 Invega Paliperidone Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/07/395/001-064 Prolonged release tablet 5N05AX13 27.6.2007 25.6.2007 Pergoveris Follitropin alfa/lutropin alfa Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/07/396/001-003 Powder and solvent for solution for injection G03GA05/G03GA07 27.6.2007 29.6.2007 Circadin Melatonin Neurim Pharmaceuticals EEC Limited 6 Fortuna Court Calleva Park Aldermaston Berkshire RG7 8UB United Kingdom EU/1/07/392/001 Prolonged-release tablet N05CM17 5.7.2007 29.6.2007 Siklos Hydroxycarbamide Addmedica 84, rue d'Amsterdam F-75009 Paris EU/1/07/397/001 Film-coated tablet L01XX05 5.7.2007

— 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 1.6.2007 Renagel Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/99/123/001-012 5.6.2007 1.6.2007 Rebetol Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/99/107/001-005 5.6.2007 4.6.2007 Myocet Zeneus Pharma Limited The Magdalen Centre Oxford Science Park Oxford OX4 4GA United Kingdom EU/1/00/141/001 7.6.2007 Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort 6.6.2007 4.6.2007 Vasovist Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin EU/1/05/313/001-009 6.6.2007 4.6.2007 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 6.6.2007 4.6.2007 Humira Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 6.6.2007 4.6.2007 Trudexa Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-010 6.6.2007 4.6.2007 Orgalutran N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH Oss Nederland EU/1/00/130/001-002 6.6.2007 4.6.2007 TRIZIVIR Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/002-003 6.6.2007 4.6.2007 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/176/001-006 6.6.2007 4.6.2007 Avandamet SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom EU/1/03/258/001-022 6.6.2007 5.6.2007 Azomyr Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/00/157/001-067 7.6.2007 5.6.2007 Aerius Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/00/160/001-069 8.6.2007 5.6.2007 Neoclarityn Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/00/161/001-067 7.6.2007 5.6.2007 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/001-020 EU/1/04/276/024-036 7.6.2007 5.6.2007 Trisenox Cephalon UK Ltd 20 Alan Turing Road Surrey Research Park Guildford Surrey GU2 7YF United Kingdom EU/1/02/204/001 8.6.2007 Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort, Cedex 7.6.2007 5.6.2007 Visudyne Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/00/140/001 7.6.2007 7.6.2007 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 11.6.2007 8.6.2007 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/001-009 12.6.2007 8.6.2007 Vistide Pfizer Enterprises SARL 51, Avenue Kennedy-Rond Point du Kirchberg L-1855 Luxembourg EU/1/97/037/001 12.6.2007 13.6.2007 ViraferonPeg Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/00/132/001-050 15.6.2007 13.6.2007 Azopt Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/00/129/001-003 15.6.2007 13.6.2007 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/220/001-005 15.6.2007 13.6.2007 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-017 15.6.2007 13.6.2007 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-015 15.6.2007 13.6.2007 PegIntron Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel EU/1/00/131/001-050 15.6.2007 13.6.2007 Silgard Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-017 15.6.2007 14.6.2007 Rapilysin Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/018/001 19.6.2007 19.6.2007 Zyprexa Velotab Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-016 21.6.2007 20.6.2007 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/001-011 25.6.2007 20.6.2007 Cialis Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom EU/1/02/237/001-008 21.6.2007 21.6.2007 Levemir Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/04/278/001-009 25.6.2007 21.6.2007 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 25.6.2007 21.6.2007 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 25.6.2007 21.6.2007 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b EU/1/98/070/005a-005b EU/1/98/070/006a-006b EU/1/98/070/007a-007b 25.6.2007 21.6.2007 Synagis Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/99/117/001-002 25.6.2007 21.6.2007 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/03/247/001-002 25.6.2007 21.6.2007 Revasc Canyon Pharmaceuticals Ltd 20-22 Bedford Row London WC1R 4JS United Kingdom EU/1/97/043/001-003 25.6.2007 21.6.2007 Cystagon Orphan Europe S.à r.l. Immeuble «Le Guillaumet» F-92046 Paris La Défense EU/1/97/039/001-004 25.6.2007 21.6.2007 PEGASYS Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/221/001-010 25.6.2007 22.6.2007 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b 26.6.2007 25.6.2007 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/337/001-013 27.6.2007 25.6.2007 NeoRecormon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/97/031/001-003 EU/1/97/031/019-046 27.6.2007 27.6.2007 Vaniqa Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/01/173/001-003 29.6.2007 29.6.2007 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-002 3.7.2007 29.6.2007 Ferriprox Apotex Europe Ltd Rowan House 41 London Street Reading Berkshire RG1 4PS United Kingdom EU/1/99/108/001 3.7.2007 Apotex Europe B.V. Darwingweg 20 2333 CR Leiden Nederland 3.7.2007 29.6.2007 Humira Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/256/001-010 5.7.2007 29.6.2007 Viramune Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 5.7.2007 29.6.2007 Trudexa Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/03/257/001-010 5.7.2007 29.6.2007 Prandin Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/162/003-006 EU/1/00/162/009-012 EU/1/00/162/015-021 5.7.2007 29.6.2007 NovoNorm Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/98/076/004-007 EU/1/98/076/011-014 EU/1/98/076/018-024 5.7.2007 29.6.2007 Tygacil Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/06/336/001 5.7.2007 29.6.2007 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-035 5.7.2007

— 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 20.6.2007 PRILACTONE Spironolactone CEVA SANTE ANIMALE Z.I. la Ballastière F-33500 Libourne EU/2/07/074/001-006 Tablet QC03DA01 22.6.2007 21.6.2007 Circovac Inactivated porcine circovirus type 2 MERIAL 29, avenue Tony Garnier F-69007 Lyon EU/2/07/075/001-004 Emulsion and suspension for emulsion for injection QI09AA07 25.6.2007

— 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 14.6.2007 Vaxxitek HVT+ IBD Merial 29, Avenue Tony Garnier F-69007 Lyon EU/2/02/032/001 19.6.2007

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.