EN Official Journal of the European Union C 124/4

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 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 124/03)

— 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 6.4.2006 ProQuad Measles, Mumps, Rubella and Varicella Vaccine (Live) Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon EU/1/05/323/001-011 Powder and solvent for suspension for injection J07BD54 10.4.2006 12.4.2006 Omnitrope Somatropin Sandoz GmbH Biochemiestraße 10 A-6250 Kundl EU/1/06/332/001-003 Powder and solvent for solution for injection H01AC01 20.4.2006 24.4.2006 Valtropin Somatropin BioPartners GmbH Eisenstraße 3 D-65428 Rüsselsheim EU/1/06/335/001 Powder and solvent for solution for injection (multi-use) H01A C01 26.4.2006 24.4.2006 Preotact Parathyroid hormone Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde EU/1/06/339/001-002 powder and solvent for sol for injection H05 AA03 26.4.2006 24.4.2006 DuoTrav Travoprost/Timolol Alcon Laboratories (UK) Ltd Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom EU/1/06/338/001-003 Eye drops, solution S01ED51 26.4.2006 24.4.2006 Tygacil Tigecycline Wyeth Europa Ltd Huntercombe Lane South, Taplow Maidenhead, Berkshire SL6 0PH United Kingdom EU/1/06/336/001 Powder for solution for infusion (Non applicable) 26.4.2006

— 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 3.4.2006 Kogenate Bayer Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen EU/1/00/143/001-006 5.4.2006 3.4.2006 Helixate NexGen Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen EU/1/00/144/001-003 5.4.2006 3.4.2006 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead, Berkshire, SL6 0PH United Kingdom EU/1/99/126/001-011 5.4.2006 6.4.2006 NeuroBloc Solstice Neurosciences Ltd Fitzwilton House Wilton Place, Dublin 2, Ireland EU/1/00/166/001-003 10.4.2006 6.4.2006 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/050/001-006 EU/1/97/050/009-012 10.4.2006 6.4.2006 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 10.4.2006 6.4.2006 Kaletra Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/01/172/001-003 10.4.2006 6.4.2006 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/97/051/001-006 EU/1/97/051/009-012 10.4.2006 10.4.2006 Trizivir Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/00/156/001-002 13.4.2006 10.4.2006 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/96/009/001-009 13.4.2006 12.4.2006 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 B-1348 Louvain-La-Neuve EU/1/00/167/001-007 19.4.2006 18.4.2006 Vaniqa Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire RG24 8EP United Kingdom EU/1/01/173/001-003 20.4.2006 18.4.2006 Orfadin Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm EU/1/04/303/001-003 20.4.2006 18.4.2006 Telzir Glaxo Group Ltd Greenford Road Greenford, Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 20.4.2006 24.4.2006 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 26.4.2006 24.4.2006 SonoVue Bracco International BV Strawinskylaan 3051 1077 ZX Amsterdam Nederland EU/1/01/177/001-002 26.4.2006 24.4.2006 Xigris Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/02/225/001-002 26.4.2006 24.4.2006 Ammonaps Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm Orphan Europe, Immeuble ‘Le Guillaumet’ F-92046 Paris La Défense EU/1/99/120/001-004 26.4.2006 24.4.2006 Trazec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/175/001, EU/1/01/175/004-008, EU/1/01/175/011-015 EU/1/01/175/018-021 26.4.2006 24.4.2006 Starlix Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/174/001-021 26.4.2006 24.4.2006 Trisenox Cephalon UK Ltd 20 Alan Turing Road Surrey Research Park Guildford Surrey, GU2 7YF United Kingdom Cell Therapeutics (UK) Limited 100 Pall Mall London SW1Y 5HP United Kingdom EU/1/02/204/001 27.4.2006 24.4.2006 Zometa Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/176/001-006 26.4.2006 24.4.2006 TARGRETIN Ligand Pharmaceuticals UK Ltd Innovis House 108 High Street, Crawley West Sussex RH10 1BB United Kingdom EU/1/01/178/001 26.4.2006 24.4.2006 Xolair Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/319/001-004 26.4.2006 27.4.2006 Emtriva Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/03/261/001-002 2.5.2006 27.4.2006 Aldara Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex EU/1/98/080/001 2.5.2006 27.4.2006 Comtess Orion Corporation, Orionintie 1 FIN-02200 Espoo EU/1/98/082/001-004 2.5.2006 27.4.2006 Rebetol Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles, — Stallestraat, 73 — B-1180 Brussel EU/1/99/107/001-005 2.5.2006 27.4.2006 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104, D-60318 Frankfurt/Main EU/1/02/218/001-011 2.5.2006 27.4.2006 Abilify Otsuka Pharmaceutical Europe Ltd Commonwealth House 2 Chalkhill Road Hammersmith London W6 8DW United Kingdom EU/1/04/276/033-035 2.5.2006 27.4.2006 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland EU/1/02/205/001-002 2.5.2006 27.4.2006 Ebixa H. Lundbeck A/S, Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-013 1.5.2006 27.4.2006 Levviax Aventis Pharma SA 20 Avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 2.5.2006 27.4.2006 Ketek Aventis Pharma SA 20 Avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 2.5.2006 27.4.2006 Taxotere Aventis Pharma SA 20 avenue Raymond Aron F-92165 Antony Cedex EU/1/95/002/001-002 4.5.2006 27.4.2006 Fasturtec Sanofi-Aventis, 174 avenue de France F-75013 Paris EU/1/00/170/001-002 2.5.2006 27.4.2006 PegIntron Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/00/131/001-050 2.5.2006 27.4.2006 ViraferonPeg Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/00/132/001-050 2.5.2006 27.4.2006 Viraferon Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/99/128/001-037 2.5.2006 27.4.2006 IntronA Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/99/127/001-044 2.5.2006 27.4.2006 Keppra UCB SA Allée de la recherche, 60 B-1070 Bruxelles EU/1/00/146/001-030 2.5.2006

— 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 10.4.2006 Flexicam Meloxicam Omnipharm Ltd, The Spire Egypt Road Nottingham NG7 7GD United Kingdom EU/2/06/058/001-003 oral suspension QM01AC06 13.4.2006

— 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 10.4.2006 Porcilis Porcoli Intervet International BV (NL) Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/96/001/001-010 13.4.2006 18.4.2006 Eurican Herpes 205 Merial, 29 avenue Tony Garnier F-69007 Lyon EU/2/01/029/001-003 20.4.2006 24.4.2006 Sevoflo Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/2/02/035/007 26.4.2006

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 of 30.4.2004, p. 1.