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Document 52005XC0225(01)
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)
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)
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)
OJ C 49, 25.2.2005, p. 2–5
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
25.2.2005 |
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.