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Document 52008XC0926(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 245, 26.9.2008, p. 15–20
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
26.9.2008 |
EN |
Official Journal of the European Union |
C 245/15 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2008/C 245/03)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|||
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28.8.2008 |
INTELENCE |
Etravirine |
|
EU/1/08/468/001 |
Tablet |
(Non applicable) |
1.9.2008 |
|||
|
29.8.2008 |
Vimpat |
Lacosamide |
|
EU/1/08/470/001-013 |
Film-coated tablet |
N03AX18 |
2.9.2008 |
|||
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EU/1/08/470/014-015 |
Syrup |
|||||||||
|
EU/1/08/470/016 |
Solution for infusion |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
|||||||
|
4.8.2008 |
Neupro |
|
EU/1/05/331/001-037 |
6.8.2008 |
|||||||
|
8.8.2008 |
Champix |
|
EU/1/06/360/001-012 |
12.8.2008 |
|||||||
|
8.8.2008 |
Vectibix |
|
EU/1/07/423/001-003 |
12.8.2008 |
|||||||
|
8.8.2008 |
Infanrix hexa |
|
EU/1/00/152/001-018 |
12.8.2008 |
|||||||
|
8.8.2008 |
Evista |
|
EU/1/98/073/001-004 |
12.8.2008 |
|||||||
|
8.8.2008 |
Avandamet |
|
EU/1/03/258/001-022 |
12.8.2008 |
|||||||
|
11.8.2008 |
Optruma |
|
EU/1/98/074/001-004 |
13.8.2008 |
|||||||
|
13.8.2008 |
Silapo |
|
EU/1/07/432/001-022 |
15.8.2008 |
|||||||
|
13.8.2008 |
Retacrit |
|
EU/1/07/431/001-019 |
15.8.2008 |
|||||||
|
13.8.2008 |
Humira |
|
EU/1/03/256/001-010 |
15.8.2008 |
|||||||
|
13.8.2008 |
Hepsera |
|
EU/1/03/251/001-002 |
15.8.2008 |
|||||||
|
13.8.2008 |
Infanrix penta |
|
EU/1/00/153/001-010 |
18.8.2008 |
|||||||
|
13.8.2008 |
Cervarix |
|
EU/1/07/419/001-009 |
18.8.2008 |
|||||||
|
22.8.2008 |
Evista |
|
EU/1/98/073/001-004 |
26.8.2008 |
|||||||
|
|||||||||||
|
22.8.2008 |
Kaletra |
|
EU/1/01/172/001-006 |
26.8.2008 |
|||||||
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22.8.2008 |
Baraclude |
|
EU/1/06/343/001-007 |
26.8.2008 |
|||||||
|
22.8.2008 |
SUTENT |
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EU/1/06/347/001-006 |
26.8.2008 |
|||||||
|
22.8.2008 |
Fosavance |
|
EU/1/05/310/001-009 |
26.8.2008 |
|||||||
|
22.8.2008 |
Zalasta |
|
EU/1/07/415/001-056 |
26.8.2008 |
|||||||
|
22.8.2008 |
Arixtra |
|
EU/1/02/206/001-035 |
26.8.2008 |
|||||||
|
22.8.2008 |
Revlimid |
|
EU/1/07/391/001-004 |
26.8.2008 |
|||||||
|
25.8.2008 |
Abilify |
|
EU/1/04/276/001-020 EU/1/04/276/024-036 |
27.8.2008 |
|||||||
|
25.8.2008 |
TARGRETIN |
|
EU/1/01/178/001 |
27.8.2008 |
|||||||
|
25.8.2008 |
Emselex |
|
EU/1/04/294/001-028 |
27.8.2008 |
|||||||
|
25.8.2008 |
Sifrol |
|
EU/1/97/050/001-006 EU/1/97/050/009-012 |
27.8.2008 |
|||||||
|
25.8.2008 |
Humira |
|
EU/1/03/256/001-010 |
27.8.2008 |
|||||||
|
25.8.2008 |
Revatio |
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EU/1/05/318/001 |
27.8.2008 |
|||||||
|
25.8.2008 |
Prialt |
|
EU/1/04/302/001-004 |
27.8.2008 |
|||||||
|
25.8.2008 |
NovoSeven |
|
EU/1/96/006/001-006 |
27.8.2008 |
|||||||
|
26.8.2008 |
Viagra |
|
EU/1/98/077/002-004 EU/1/98/077/006-008 EU/1/98/077/010-019 |
28.8.2008 |
|||||||
|
28.8.2008 |
Rasilez |
|
EU/1/07/405/001-020 |
1.9.2008 |
|||||||
|
28.8.2008 |
Tekturna |
|
EU/1/07/408/001-020 |
1.9.2008 |
|||||||
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28.8.2008 |
Raptiva |
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EU/1/04/291/001-003 |
1.9.2008 |
|||||||
|
28.8.2008 |
ISENTRESS |
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EU/1/07/436/001-002 |
1.9.2008 |
|||||||
|
28.8.2008 |
Enviage |
|
EU/1/07/406/001-020 |
1.9.2008 |
|||||||
|
28.8.2008 |
Sprimeo |
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EU/1/07/407/001-020 |
1.9.2008 |
|||||||
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28.8.2008 |
Riprazo |
|
EU/1/07/409/001-020 |
1.9.2008 |
|||||||
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29.8.2008 |
Avastin |
|
EU/1/04/300/001-002 |
2.9.2008 |
|||||||
|
29.8.2008 |
Nespo |
|
EU/1/01/184/001-073 |
2.9.2008 |
|||||||
|
29.8.2008 |
Enbrel |
|
EU/1/99/126/001-018 |
1.9.2008 |
|||||||
|
29.8.2008 |
Velcade |
|
EU/1/04/274/001-002 |
2.9.2009 |
|||||||
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29.8.2008 |
Humira |
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EU/1/03/256/001-010 |
2.9.2009 |
|||||||
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29.8.2008 |
Prezista |
|
EU/1/06/380/001 |
2.9.2009 |
|||||||
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29.8.2008 |
Truvada |
|
EU/1/04/305/001-002 |
2.9.2009 |
|||||||
|
29.8.2008 |
Neupro |
|
EU/1/05/331/038-055 |
2.9.2009 |
|||||||
|
29.8.2008 |
Neupro |
|
EU/1/05/331/001-055 |
2.9.2009 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)
|
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 |
|||
|
22.8.2008 |
Protopy |
|
EU/1/02/202/001-006 |
26.8.2008 |
|||
|
28.8.2008 |
Quintanrix |
|
EU/1/04/301/001-005 |
1.9.2008 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
||||||
|
13.8.2008 |
Dexdomitor |
|
EU/2/02/033/001-002 |
15.8.2008 |
||||||
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22.8.2008 |
Suvaxyn Aujeszky |
|
EU/2/98/009/001-006 |
26.8.2008 |
||||||
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25.8.2008 |
Zubrin |
|
EU/2/00/028/002-008 |
27.8.2008 |
||||||
|
25.8.2008 |
Circovac |
|
EU/2/07/075/001-004 |
27.8.2008 |
||||||
|
25.8.2008 |
Profender |
|
EU/2/05/054/018-031 |
27.8.2008 |
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 |
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Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.