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Document 52005XC1028(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
ĠU C 268, 28.10.2005, p. 2–6
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
28.10.2005 |
EN |
Official Journal of the European Union |
C 268/2 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005
(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))
(2005/C 268/02)
— 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 |
|
19.9.2005 |
Tarceva |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY |
EU/1/05/311/001-003 |
21.9.2005 |
— 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 |
|
5.9.2005 |
Ventavis |
Schering AG, Müllerstraße 170-178, DE-13342 Berlin |
EU/1/03/255//001-003 |
8.9.2005 |
|
5.9.2005 |
Trazec |
Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB |
EU/1/01/175/001-021 |
8.9.2005 |
|
5.9.2005 |
Forsteo |
Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten |
EU/1/03/247/001-002 |
7.9.2005 |
|
5.9.2005 |
Starlix |
Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB |
EU/1/01/174/001-021 |
8.9.2005 |
|
7.9.2005 |
DaTSCAN |
GE Healthcare Limited, UK-Little Chalfont Bucks HP7 9NA |
EU/1/00/135/001-002 |
9.9.2005 |
|
7.9.2005 |
Emtriva |
Gilead Sciences International Limited, UK-Cambridge CB1 6GT |
EU/1/03/261/001-003 |
9.9.2005 |
|
7.9.2005 |
KOGENATE Bayer |
Bayer AG, DE-51368 Leverkusen |
EU/1/00/143/001-006 |
9.9.2005 |
|
7.9.2005 |
Helixate NexGen |
Bayer AG, DE-51368 Leverkusen |
EU/1/00/144/001-003 |
9.9.2005 |
|
8.9.2005 |
Nespo |
Dompé Biotec S.p.A., Via San Martino, 12, IT-20122 Milano |
EU/1/01/184/001-056 |
13.9.2005 |
|
8.9.2005 |
Herceptin |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY |
EU/1/00/145/001 |
13.9.2005 |
|
8.9.2005 |
Xagrid |
Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP |
EU/1/04/295/001 |
13.9.2005 |
|
8.9.2005 |
Kivexa |
Glaxo Group Ltd, Berkeley Avenue, Greenford, UK-Middlesex UB6 0NN |
EU/1/04/298/001-002 |
13.9.2005 |
|
8.9.2005 |
Ziagen |
Glaxo Group Ltd, Greenford, UK-Middlesex UB6 0NN |
EU/1/99/112/001-002 |
13.9.2005 |
|
8.9.2005 |
Aranesp |
Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda |
EU/1/01/185/001-056 |
13.9.2005 |
|
8.9.2005 |
Karvezide |
Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH |
EU/1/98/085/001-020 |
13.9.2005 |
|
8.9.2005 |
CoAprovel |
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris |
EU/1/98/086/001-020 |
13.9.2005 |
|
8.9.2005 |
PegIntron |
Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel |
EU/1/00/131/001-050 |
13.9.2005 |
|
8.9.2005 |
ViraferonPeg |
Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel |
EU/1/00/132/001-050 |
13.9.2005 |
|
8.9.2005 |
Raptiva |
Serono Europe Limited, 56, Marsh Wall, UK-London E14 9TP |
EU/1/04/291/001-002 |
14.9.2005 |
|
8.9.2005 |
Pylobactell |
Torbet Laboratories Limited, Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, UK-Norfolk NR13 6LH |
EU/1/98/064/001 |
13.9.2005 |
|
13.9.2005 |
Infanrix Hexa |
GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, BE-1330 Rixensart |
EU/1/00/152/001-018 |
14.9.2005 |
|
13.9.2005 |
Somavert |
Pfizer Limited, Sandwich, UK-Kent, CT13 9NJ |
EU/1/02/240/001-004 |
14.9.2005 |
|
13.9.2005 |
Hepsera |
Gilead Sciences International Limited, UK-Cambridge CB1 6GT |
EU/1/03/251/001 |
15.9.2005 |
|
13.9.2005 |
Erbitux |
Merck KGaA, Frankfurter Straße 250, DE-64293 Darmstadt |
EU/1/04/281/001 |
14.9.2005 |
|
13.9.2005 |
Dynepo |
Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex FR-92165 |
EU/1/02/211/001-009 |
15.9.2005 |
|
13.9.2005 |
Infanrix Penta |
GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, BE-1330 Rixensart |
EU/1/00/153/001-010 |
14.9.2005 |
|
13.9.2005 |
Mimpara |
Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda |
EU/1/04/292/001-012 |
14.9.2005 |
|
13.9.2005 |
Avandamet |
SmithKline Beecham plc, 980 Great West Road, Brentford, UK-Middlesex TW8 9GS |
EU/1/03/258/013-014 |
14.9.2005 |
|
13.9.2005 |
Karvea |
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA |
EU/1/97/049/001-030 |
15.9.2005 |
|
13.9.2005 |
Keppra |
UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel |
EU/1/00/146/001-029 |
16.9.2005 |
|
13.9.2005 |
Keppra |
UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel |
EU/1/00/146/001-027 |
16.9.2005 |
|
13.9.2005 |
Aprovel |
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris |
EU/1/97/046/001-030 |
15.9.2005 |
|
15.9.2005 |
Hepsera |
Gilead Sciences International Limited, UK-Cambridge CB1 6GT |
EU/1/03/251/001 |
20.9.2005 |
|
15.9.2005 |
Cymbalta |
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten |
EU/1/04/296/001-006 |
20.9.2005 |
|
15.9.2005 |
Ariclaim |
Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein |
EU/1/04/283/001-007 |
20.9.2005 |
|
15.9.2005 |
Yentreve |
Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten |
EU/1/04/280/001-007 |
20.9.2005 |
|
15.9.2005 |
Xeristar |
Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein |
EU/1/04/297/001-006 |
20.9.2005 |
|
15.9.2005 |
Bonviva |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY |
EU/1/03/265/003-004 |
20.9.2005 |
|
15.9.2005 |
Bondenza |
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY |
EU/1/03/266/003-004 |
20.9.2005 |
|
15.9.2005 |
Myocet |
Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, IE-County Clare |
EU/1/00/141/001 |
20.9.2005 |
|
15.9.2005 |
NovoMix |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd |
EU/1/00/142/004-005 EU/1/00/142/009-010 |
20.9.2005 |
|
16.9.2005 |
REYATAZ |
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA |
EU/1/03/267/001-007 |
20.9.2005 |
|
19.9.2005 |
Ariclaim |
Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein |
EU/1/04/283/001-007 |
21.9.2005 |
|
19.9.2005 |
Arava |
Aventis Pharma Deutschland GmbH, DE-65926 Frankfurt am Main |
EU/1/99/118/001-010 |
21.9.2005 |
|
19.9.2005 |
Yentreve |
Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten |
EU/1/04/280/001-007 |
21.9.2005 |
|
19.9.2005 |
Hexavac |
Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, FR-69007 Lyon |
EU/1/00/147/001-012 |
21.9.2005 |
|
22.9.2005 |
Iscover |
Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH |
EU/1/98/070/001a — 001b EU/1/98/070/002a — 002b EU/1/98/070/003a — 003b EU/1/98/070/004a — 001b |
26.9.2005 |
|
22.9.2005 |
Plavix |
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris |
EU/1/98/069/001a — 001b EU/1/98/069/002a — 002b EU/1/98/069/003a — 003b EU/1/98/069/004a — 001b |
26.9.2005 |
|
29.9.2005 |
Remicade |
Centocor B.V., Einsteinweg 101, NL-2333 CB Leiden |
EU/1/99/116/001-003 |
4.10.2005 |
— Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)
|
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 |
|
22.9.2005 |
CEA-Scan |
Immunomedics GmbH, Otto-Röhm-Straße 69, DE-64293 Darmstadt |
EU/1/96/023/001 |
27.9.2005 |
— 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 |
|
19.9.2005 |
Pirsue |
PFIZER Ltd, Ramsgate Road, Sandwich, UK-Kent CT13 9NJ |
EU/2/00/027/001-003 |
21.9.2005 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
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UK-London E14 4HB |
(1) OJ L 214 of 24.8.1993, p. 1.