EN Official Journal of the European Union C 102/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.3.2006 to 31.3.2006

(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 102/02)

— 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 29.3.2006 Myozyme alglucosidase alpha Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/06/333/001-003 Powder for concentrate for solution for infusion A16AB07 31.3.2006

— 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 2.3.2006 Prometax Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/98/092/001-018 6.3.2006 8.3.2006 Litak Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen EU/1/04/275/001-002 10.3.2006 9.3.2006 Kentera Nicobrand Limited 189 Casteroe Road Coleraine Northern Ireland BT51 3 RP EU/1/03/270/001-003 13.3.2006 13.3.2006 Cellcept Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/96/005/001-006 15.3.2006 13.3.2006 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/001-011 15.3.2006 15.3.2006 Angiox The Medicines Company UK Ltd Suite B Park House 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom EU/1/04/289/001-002 17.3.2006 20.3.2006 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/086/001-022 22.3.2006 20.3.2006 Karvezide Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom EU/1/98/085/001-022 22.3.2006 20.3.2006 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 22.3.2006 20.3.2006 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/022/016-017 22.3.2006 20.3.2006 Prialt Elan Pharma International Ltd WIL House Shannon Business Park Shannon County Clare Ireland EU/1/04/302/004 22.3.2006 20.3.2006 Lyrica PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-032 22.3.2006 20.3.2006 Mabthera Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/98/067/001-002 22.3.2006 21.3.2006 NutropinAq IPSEN Limited 190 Bath Road Slough Berkshire SLI 3XE United Kingdom EU/1/00/164/003-005 23.3.2006 21.3.2006 Exubera PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Aventis/Pfizer EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom EU/1/05/327/001-017 23.3.2006 22.3.2006 Kinzalmono Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen EU/1/98/091/001-014 24.3.2006 22.3.2006 NeoSpect CIS bio international Route Nationale 306 Saclay Boite Postale 32 F-91192 Gifsur-Yvette Amersham Health AS Nycoveien 1-2 P.O. Box 4220 Nydalen N-0401 Oslo EU/1/00/154/001-002 24.3.2006 22.3.2006 Tarceva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/05/311/001-003 24.3.2006 22.3.2006 Kinzalkomb Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen EU/1/02/214/001-010 24.3.2006 22.3.2006 Pritor Bayer HealthCare AG D-51368 Leverkusen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/98/089/001-019 24.3.2006 22.3.2006 PritorPlus Bayer HealthCare AG D-51368 Leverkusen Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom EU/1/02/215/001-012 24.3.2006 22.3.2006 Levviax Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 24.3.2006 22.3.2006 Ketek Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 24.3.2006 22.3.2006 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kingdom EU/1/97/033/001-003 24.3.2006 23.3.2006 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/01/196/001-003 28.3.2006 29.3.2006 Actos Takeda Europe R&D Centre Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/150/001-024 31.3.2006 29.3.2006 IntronA Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/99/127/001-044 31.3.2006 29.3.2006 Parareg Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/04/293/001-012 31.3.2006 29.3.2006 Mimpara Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/04/292/001-012 31.3.2006 29.3.2006 Viraferon Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/99/128/001-037 31.3.2006 29.3.2006 Glustin Takeda Europe R&D Centre Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom EU/1/00/151/001-022 31.3.2006 29.3.2006 Ariclaim Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/283/001-007 31.3.2006 29.3.2006 Raptiva Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom EU/1/04/291/001-002 5.4.2006 29.3.2006 Hepsera Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/03/251/001 31.3.2006 29.3.2006 Erbitux Merck KGaA Frankfurter Straße 250 D-64293 Darmstadt EU/1/04/281/001 31.3.2006 29.3.2006 Keppra UCB S.A. Allée de la recherche, 60/Researchdreef, 60 B-1070 Bruxelles/Brussel EU/1/00/146/030 31.3.2006 29.3.2006 Rebetol Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel EU/1/99/107/001-005 30.3.2006 29.3.2006 Protopy Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/202/001-006 31.3.2006 29.3.2006 Protopic Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München EU/1/02/201/001-006 31.3.2006 29.3.2006 Aptivus Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/05/315/001 31.3.2006 29.3.2006 Bondenza Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/03/266/005-006 31.3.2006 29.3.2006 Xeristar Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein EU/1/04/297/001-007 31.3.2006 29.3.2006 YENTREVE Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/280/001-007 31.3.2006 29.3.2006 Prialt Elan Pharma International Ltd WIL House Shannon Business Park Shannon County Clare Ireland EU/1/04/302/001-004 3.4.2006 29.3.2006 NovoMix Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/009-022 31.3.2006 29.3.2006 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/04/296/001-007 31.3.2006 29.3.2006 Pedea Orphan Europe Immeuble «Le Guillaumet» F-92046 Paris La Défense EU/1/04/284/001 31.3.2006 29.3.2006 Bonviva Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/1/03/265/005-006 31.3.2006 29.3.2006 NovoRapid Novo Nordisk A/S Novo Allé DK-2880 Bagsværd EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 31.3.2006 29.3.2006 InductOs Wyeth Europa Ltd. Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/02/226/001 31.3.2006 29.3.2006 Truvada Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom EU/1/04/305/001 31.3.2006

— 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 15.3.2006 Zubrin Schering Plough Limited Schering Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom EU/2/00/028/002-008 17.3.2006 21.3.2006 Porcilis Pesti Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/99/016/001-006 23.3.2006 23.3.2006 METACAM Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/97/004/016-023 28.3.2006

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, 30.4.2004, p. 1.