EN Official Journal of the European Union C 164/6

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2008 to 31 May 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 164/08)

— 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 14.5.2008 Prepandrix Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/08/453/001 Suspension and emulsion for emulsion for injection J07BB02 16.5.2008 20.5.2008 Pandemrix Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart EU/1/08/452/001 Suspension and emulsion for emulsion for injection J07BB02 22.5.2008 20.5.2008 Extavia Interferon beta-1b Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/08/454/001-004 Powder and solvent for solution for injection L03AB08 22.5.2008

— Issuing 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 21.5.2008 CIMZIA UCB S.A. Allée de la Recherche, 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel — 23.5.2008 22.5.2008 Rhucin Pharming Group N.V. Darwinweg 24 2333 CR Leiden Nederland — 28.5.2008

— 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 8.5.2008 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/001-049 14.5.2008 8.5.2008 Ebixa H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby EU/1/02/219/022-049 14.5.2008 8.5.2008 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/001-029 14.5.2008 8.5.2008 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main EU/1/02/218/016-029 14.5.2008 21.5.2008 Prometax Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/092/001-026 23.5.2008 21.5.2008 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom EU/1/04/295/001 23.5.2008 21.5.2008 Foscan Biolitec pharma Ltd United Drug House Magna Drive Dublin 24 Ireland EU/1/01/197/001-005 23.5.2008 22.5.2008 Zevalin Bayer Schering Pharma AG D-13342 Berlin EU/1/03/264/001 27.5.2008 22.5.2008 Advate Baxter AG Industriesstraße 67 A-1220 Vienna EU/1/03/271/005-006 28.5.2008 20.5.2008 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/03/247/001-002 22.5.2008 20.5.2008 Carbaglu Orphan Europe Immeuble Le Wilson 70, Avenue du Général de Gaulle F-92800 Puteaux EU/1/02/246/001-003 22.5.2008 20.5.2008 Exelon Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/066/001-026 22.5.2008 20.5.2008 Refludan Pharmion Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom EU/1/97/035/001-004 22.5.2008 20.5.2008 Cystadane Orphan Europe S.a.r.l. Immeuble Le Wilson 70, Avenue du Général de Gaulle F-92800 Puteaux EU/1/06/379/001 22.5.2008 20.5.2008 Zavesca Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom EU/1/02/238/001 22.5.2008 20.5.2008 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 22.5.2008 20.5.2008 Aldurazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/03/253/001-003 22.5.2008 20.5.2008 Onsenal Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/03/259/001-006 22.5.2008 20.5.2008 Rebif Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/98/063/001-007 27.5.2008

— 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 21.5.2008 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/98/006/001-010 23.5.2008 21.5.2008 METACAM Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/97/004/007-008 EU/2/97/004/014-015 EU/2/97/004/027-028 EU/2/97/004/031-032 23.5.2008

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.