EN Official Journal of the European Union C 49/2

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 January 2005 to 15 February 2005

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))

(2005/C 49/02)

— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93) 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 2.2.2005 Fendrix GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, B-1330 Rixensart EU/1/04/299/001-003 4.2.2005

— Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93) 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 20.1.2005 Norvir Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom EU/1/96/016//001 EU/1/96/016/003 24.1.2005 20.1.2005 Zerit Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom EU/1/96/009/001-017 24.1.2005 20.1.2005 Avandamet SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS — United Kingdom EU/1/03/258/001-012 24.1.2005 20.1.2005 Zerit Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom EU/1/96/009/001-017 24.1.2005 20.1.2005 Rapamune Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/011-012 24.1.2005 25.1.2005 NeupoPeg Dompé Biotec S.p.A., Via San Martino, 12, I-20122 Milano EU/1/02/228/001-002 27.1.2005 25.1.2005 Neulasta Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227/001-002 27.1.2005 25.1.2005 IntronA Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles EU/1/99/127/001-044 28.1.2005 25.1.2005 Viraferon Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles EU/1/99/128/001-037 28.1.2005 25.1.2005 Xigris Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/225/001-002 27.1.2005 25.1.2005 Trudexa Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/257/001-006 27.1.2005 25.1.2005 Arixtra Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-017 27.1.2005 25.1.2005 Travatan Alcon Laboratories (UK) Ltd., Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/01/199/001-002 27.1.2005 25.1.2005 Quixidar Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-017 27.1.2005 25.1.2005 Humira Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom EU/1/03/256/001-006 27.1.2005 25.1.2005 Rebetol Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73, B-1180 Brussel EU/1/99/107/001-004 27.1.2005 25.1.2005 Rebetol Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73, B–1180 Brussel EU/1/99/107/004 27.1.2005 26.1.2005 Remicade Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-003 28.1.2005 26.1.2005 Bextra Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/239/001-030 1.2.2005 26.1.2005 Dynastat Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/209/001-008 1.2.2005 26.1.2005 Rayzon Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/210/001-008 1.2.2005 26.1.2005 Prevenar Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15, B-1348 Louvain-La-Neuve. EU/1/00/167/001-007 28.1.2005 26.1.2005 Valdyn Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/244/001-024 31.1.2005 26.1.2005 Visudyne Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom. EU/1/00/140/001 31.1.2005 26.1.2005 Pegasys Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/02/221/001-008 31.1.2005 26.1.2005 Renagel Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland EU/1/99/123/001-011 28.1.2005 31.1.2005 Tractocile Ferring AB, Soldattorpsvägen 5 — Box 30 047, Limhamn S-20061 EU/1/99/124/001-002 2.2.2005 2.2.2005 NovoNorm Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/98/076/001-002, EU/1/98/076/004-009, EU/1/98/076/011-016 EU/1/98/076/018-021 4.2.2005 4.2.2005 Prandin Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd EU/1/00/162/001-018 8.2.2005 9.2.2005 Zyprexa Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/022/016-018 11.2.2005 9.2.2005 Zyprexa Eli Lilly Nederland BV, 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/1/96/022/016-022 11.2.2005 9.2.2005 Zyprexa Velotab Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland EU/1/99/125/001-008 11.2.2005 14.2.2005 Keppra UCB S.A. — Allée de la recherche, 60, B-1070 Bruxelles — Researchdreef, 60, B-1070 Brussel EU/1/00/146/001-029 16.2.2005 14.2.2005 Avonex Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom Biogen Idec France, ‘Le Capitole’ 55, avenue des Champs Pierreux, F-92012 Nanterre Cedex. EU/1/97/033/001-003 16.2.2005 14.2.2005 Helicobacter Test INFAI INFAI, Institut für biomedizinische Analytic und NMR Imaging GmbH — Universitätsstrasse 142, D-44799 Bochum EU/1/97/045/001-004 16.2.2005 15.2.2005 Karvea Bristol-Myers Squibb Pharma EEIG — 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom EU/1/97/049/001-030 17.2.2005 15.2.2005 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC — 174 avenue de France, F-75013 Paris EU/1/97/046/001-030 17.2.2005

— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93) 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 31.1.2005 IBAFLIN Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/022/001a-001b, 002a - 002b, 003a-003b, 004a-004b EU/2/00/022/005-008, 2.2.2005 31.1.2005 METACAM Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein EU/2/97/004/007-008 2.2.2005

(1) OJ L 214 of 24 August 1993, page 1.