EN Official Journal of the European Union C 153/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2005 to 15 June 2005

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

(2005/C 153/03)

— 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 18.5.2005 Bonviva Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/03/265/001-002 24.5.2005 23.5.2005 IntronA Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/99/127/001-044 25.5.2005 23.5.2005 Viraferon Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/99/128/001-037 25.5.2005 23.5.2005 Kentera Nicobrand Limited, 189 Casteroe Road, Coleraine, Northern Ireland BT51 3 RP EU/1/03/270/001-003 25.5.2005 23.5.2005 DepoCyte SkyePharma PLC, 105 Piccadilly, London W1V 9FN, United Kingdom EU/1/01/187/001 25.5.2005 25.5.2005 Invirase Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom EU/1/96/026/002 27.5.2005 25.5.2005 PegIntron Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/00/131/001-050 27.5.2005 25.5.2005 ViraferonPeg Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/00/132/001-050 27.5.2005 2.6.2005 Azopt Alcon Laboratories (UK) Ltd., Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UK, United Kingdom EU/1/00/129/001-003 6.6.2005 2.6.2005 Onsenal Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, CT13 9NJ, United Kingdom EU/1/03/259/001-006 6.6.2005 2.6.2005 Glivec Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 6.6.2005 3.6.2005 Zavesca Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238/001 7.6.2005 3.6.2005 Ariclaim Boehringer Ingelheim International GmbH, Binger Straße 173, D-5216 Ingelheim am Rhein EU/1/04/283/001-006 7.6.2005 3.6.2005 Rebetol Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/99/107/001-004 7.6.2005 3.6.2005 Ketek Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/191/001-005 7.6.2005 3.6.2005 Levviax Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony EU/1/01/192/001-005 7.6.2005 3.6.2005 Temodal Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel EU/1/98/096/001-008 7.6.2005 3.6.2005 Valdyn Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/244/001-024 7.6.2005 10.6.2005 Taxotere Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex EU/1/95/002/001-002 14.6.2005 10.6.2005 Viracept Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/97/054/001 EU/1/97/054/003-006 14.6.2005 10.6.2005 Azilect Teva Pharma GmbH, Kandelstraße 10, D-79199 Kirchzarten EU/1/04/304/001-007 14.6.2005 10.6.2005 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 14.6.2005 10.6.2005 Rayzon Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/210/001-008 14.6.2005 10.6.2005 Dynastat Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/209/001-008 14.6.2005 10.6.2005 TachoSil Nycomed Austria GmbH, St.-Peter-Straße 25, A-4020 Linz EU/1/04/277/001-004 14.6.2005 10.6.2005 Bextra Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/02/239/001-030 14.6.2005 10.6.2005 NovoMix 30 Novo Nordisk A/S, Novo Allé, DK-880 Bagsværd EU/1/00/142/004-005 EU/1/00/142/009-010 14.6.2005 10.6.2005 Protopy Fujisawa GmbH, Neumarkter Str. 61, D-81673 München EU/1/02/202/001-006 14.6.2005 10.6.2005 Protopic Fujisawa GmbH, Neumarkter Str. 61, D-81673 München EU/1/02/201/001-006 14.6.2005 10.6.2005 Xenical Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom EU/1/98/071/001-006 14.6.2005 10.6.2005 Avandia SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/001-012 14.6.2005

— Issuing 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 19.5.2005 Naxcel Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom EU/2/05/053/001 24.5.2005

— 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 26.5.2005 Econor Novartis Animal Health Austria GmbH, Biochemiestraße 10, A-250 Kundl EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-024 30.5.2005

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 214 of 24.8.1993, p. 1.