EN Official Journal of the European Union C 115/20

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 March 2004 to 15 April 2004

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

(2004/C 115/10)

— 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 25.3.2004 PhotoBarr Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard Nederland EU/1/04/272/001-002 29.3.2004 14.4.2004 Litak Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen EU/1/04/275/001-002 19.4.2004

— 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 16.3.2004 ViraferonPeg Schering Plough Europe Rue de Stalle, 73 1180 Bruxelles EU/1/00/132/031-050 18.3.2004 16.3.2004 PegIntron Schering Plough Europe Rue de Stalle, 73 1180 Bruxelles EU/1/00/131/031-050 18.3.2004 19.3.2004 Mabthera Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom EU/1/98/067/001-002 23.3.2004 19.3.2004 NutropinAq IPSEN Limited 190 Bath Road Slough, Berkshire, SLI 3XE United Kingdom EU/1/00/164/003-005 23.3.2004 25.3.2004 Norvir Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/96/016/001 EU/1/96/016/003 29.3.2004 25.3.2004 Xeloda Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom EU/1/00/163/001-002 26.3.2004 25.3.2004 Synagis Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom EU/1/99/117/001-002 29.3.2004 25.3.2004 Infergen Yamanouchi Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland EU/1/98/087/001-003 26.3.2004 31.3.2004 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-010 2.4.2004 31.3.2004 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 2.4.2004 31.3.2004 Sonata Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom EU/1/99/102/001-008 2.4.2004 31.3.2004 Regranex Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse EU/1/99/101/001 2.4.2004 31.3.2004 Zerene Wyeth Research (UK) Limited Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom EU/1/99/099/001-006 2.4.2004 31.3.2004 Ambirix GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart EU/1/02/224/001-005 5.4.2004 5.4.2004 Prandin Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd EU/1/00/162/001-018 7.4.2004 7.4.2004 NovoRapid W28-29 Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-014 14.4.2004 13.4.2004 Ventavis Schering AG Müllerstrasse 170-178 D-13342 Berlin EU/1/03/255/001-003 16.4.2004 14.4.2004 Aranesp Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland EU/1/01/185/001-032 16.4.2004 14.4.2004 Nespo Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano EU/1/01/184/001-032 16.4.2004 14.4.2004 Zenapax Roche Registration Ltd 40 Broadwater Road Welwyn Garden City Hertfordshire, AL7 3AY EU/1/99/098/001-002 16.4.2004 14.4.2004 Forcaltonin Unigene UK Limited 63 High Road Bushey Heath, Herts, WD2 1EE EU/1/98/093/002 16.4.2004 15.4.2004 NovoMix 30 Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd EU/1/00/142/004-005 EU/1/00/142/007-010 19.4.2004

— 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 15.3.2004 Suvaxyn Aujeszky 783 +O/W Fort Dodge Animal Health Holland 36, C. J. van Houtenlaan 1381 CP Weesp Nederland EU/2/98/009/001-006 17.3.2004 15.3.2004 Quadrisol Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/97/005/001-009 17.3.2004 19.3.2004 Gonazon Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/03/040/001 23.3.2004 19.3.2004 Porcilis Pesti Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/99/016/001-006 23.3.2004 19.3.2004 Nobilis OR inac Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/02/036/001-002 23.3.2004 19.3.2004 METACAM Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein EU/2/97/004/010 23.3.2004 19.3.2004 Nobivac Bb Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/02/034/001 23.3.2004 25.3.2004 Gallivac HVT IBD Merial 29 avenue Tony Garnier F-69007 Lyon EU/2/02/032/001 26.3.2004 31.3.2004 Econor Novartis Animal Health Austria GmbH Biochemiestrasse 10 A-6250 Kundl EU/2/98/010/001-024 2.4.2004 7.4.2004 IBAFLIN Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/00/022/009-012 14.4.2004 7.4.2004 Incurin Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/00/018/001 14.4.2004 13.4.2004 Advocate Bayer Healthcare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen EU/2/03/039/001-018 16.4.2004 14.4.2004 Nobilis IB 4-91 Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/98/006/001-010 16.4.2004 14.4.2004 Pruban Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/00/024/001 16.4.2004 14.4.2004 Porcilis AR-T DF Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/00/026/001-004 16.4.2004

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 Agency for the Evaluation of Medicinal products 7, Westferry Circus Canary Wharf London E14 4HB United Kingdom

(1) OJ L 214, 24.8.1993, p. 1.