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Document 52007XC1130(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 2007 (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 October 2007 to 31 October 2007 (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 October 2007 to 31 October 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
OJ C 288, 30.11.2007, p. 7–13
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
30.11.2007 |
EN |
Official Journal of the European Union |
C 288/7 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 2007
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2007/C 288/04)
— 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 |
|||||||
2.10.2007 |
ADROVANCE |
|
EU/1/06/364/001-009 |
4.10.2007 |
|||||||
2.10.2007 |
Fuzeon |
|
EU/1/03/252/001-003 |
4.10.2007 |
|||||||
3.10.2007 |
Aclasta |
|
EU/1/05/308/001-002 |
5.10.2007 |
|||||||
4.10.2007 |
Thyrogen |
|
EU/1/99/122/001-002 |
8.10.2007 |
|||||||
4.10.2007 |
FOSAVANCE |
|
EU/1/05/310/001-009 |
11.10.2007 |
|||||||
9.10.2007 |
Arixtra |
|
EU/1/02/206/001-008 |
11.10.2007 |
|||||||
9.10.2007 |
AZILECT |
|
EU/1/04/304/001-007 |
11.10.2007 |
|||||||
9.10.2007 |
Quixidar |
|
EU/1/02/207/001-008 |
11.10.2007 |
|||||||
9.10.2007 |
Humira |
|
EU/1/03/256/001-010 |
11.10.2007 |
|||||||
9.10.2007 |
Myozyme |
|
EU/1/06/333/001-003 |
11.10.2007 |
|||||||
15.10.2007 |
Aptivus |
|
EU/1/05/315/001 |
19.10.2007 |
|||||||
15.10.2007 |
Levemir |
|
EU/1/04/278/004-006 |
18.10.2007 |
|||||||
15.10.2007 |
Ionsys |
|
EU/1/05/326/001 |
18.10.2007 |
|||||||
15.10.2007 |
Foscan |
|
EU/1/01/197/003-005 |
18.10.2007 |
|||||||
15.10.2007 |
Enbrel |
|
EU/1/99/126/013-015 |
18.10.2007 |
|||||||
15.10.2007 |
Elaprase |
|
EU/1/06/365/001-003 |
18.10.2007 |
|||||||
15.10.2007 |
Zevalin |
|
EU/1/03/264/001 |
18.10.2007 |
|||||||
15.10.2007 |
Karvezide |
|
EU/1/98/085/001-034 |
18.10.2007 |
|||||||
15.10.2007 |
CoAprovel |
|
EU/1/98/086/001-034 |
23.10.2007 |
|||||||
18.10.2007 |
Zenapax |
|
EU/1/99/098/001-002 |
23.10.2007 |
|||||||
18.10.2007 |
Cialis |
|
EU/1/02/237/001-008 |
22.10.2007 |
|||||||
|
24.10.2007 |
||||||||||
19.10.2007 |
Zometa |
|
EU/1/01/176/001-006 |
23.10.2007 |
|||||||
19.10.2007 |
Invirase |
|
EU/1/96/026/001-002 |
23.10.2007 |
|||||||
19.10.2007 |
Viracept |
|
EU/1/97/054/001 EU/1/97/054/003-005 |
23.10.2007 |
|||||||
19.10.2007 |
Keppra |
|
EU/1/00/146/001-030 |
23.10.2007 |
|||||||
19.10.2007 |
Cellcept |
|
EU/1/96/005/001-006 |
23.10.2007 |
|||||||
19.10.2007 |
Fasturtec |
|
EU/1/00/170/001-002 |
23.10.2007 |
|||||||
22.10.2007 |
Aptivus |
|
EU/1/05/315/001 |
24.10.2007 |
|||||||
22.10.2007 |
Fabrazyme |
|
EU/1/01/188/001-006 |
24.10.2007 |
|||||||
22.10.2007 |
Zevalin |
|
EU/1/03/264/001 |
24.10.2007 |
|||||||
23.10.2007 |
ACOMPLIA |
|
EU/1/06/344/001-011 |
25.10.2007 |
|||||||
23.10.2007 |
Tritanrix HepB |
|
EU/1/96/014/001-003 |
25.10.2007 |
|||||||
23.10.2007 |
Vasovist |
|
EU/1/05/313/001-009 |
25.10.2007 |
|||||||
23.10.2007 |
Telzir |
|
EU/1/04/282/001-002 |
25.10.2007 |
|||||||
23.10.2007 |
Zimulti |
|
EU/1/06/345/001-011 |
25.10.2007 |
|||||||
23.10.2007 |
Hepsera |
|
EU/1/03/251/001-002 |
25.10.2007 |
|||||||
24.10.2007 |
Hycamtin |
|
EU/1/96/027/001 EU/1/96/027/003-005 |
26.10.2007 |
|||||||
24.10.2007 |
Competact |
|
EU/1/06/354/001-009 |
26.10.2007 |
|||||||
24.10.2007 |
Tamiflu |
|
EU/1/02/222/001-004 |
26.10.2007 |
|||||||
24.10.2007 |
Avastin |
|
EU/1/04/300/001-002 |
26.10.2007 |
|||||||
24.10.2007 |
Tygacil |
|
EU/1/06/336/001 |
26.10.2007 |
|||||||
24.10.2007 |
FOSAVANCE |
|
EU/1/05/310/001-009 |
26.10.2007 |
|||||||
24.10.2007 |
SUTENT |
|
EU/1/06/347/001-006 |
26.10.2007 |
|||||||
24.10.2007 |
Kaletra |
|
EU/1/01/172/001-005 |
26.10.2007 |
|||||||
29.10.2007 |
Abilify |
|
EU/1/04/276/033-035 |
31.10.2007 |
|||||||
29.10.2007 |
Zonegran |
|
EU/1/04/307/001-013 |
31.10.2007 |
|||||||
29.10.2007 |
Luminity |
|
EU/1/06/361/001-002 |
31.10.2007 |
|||||||
29.10.2007 |
Nexavar |
|
EU/1/06/342/001 |
31.10.2007 |
|||||||
30.10.2007 |
Noxafil |
|
EU/1/05/320/001 |
5.11.2007 |
|||||||
30.10.2007 |
Posaconazole SP |
|
EU/1/05/321/001 |
5.11.2007 |
|||||||
30.10.2007 |
Remicade |
|
EU/1/99/116/001-003 |
1.11.2007 |
|||||||
30.10.2007 |
Helixate NexGen |
|
EU/1/00/144/001-003 |
2.11.2007 |
|||||||
30.10.2007 |
KOGENATE Bayer |
|
EU/1/00/143/001-009 |
2.11.2007 |
|||||||
30.10.2007 |
PegIntron |
|
EU/1/00/131/001-050 |
5.11.2007 |
|||||||
30.10.2007 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
5.11.2007 |
|||||||
30.10.2007 |
Epivir |
|
EU/1/96/015/001-005 |
1.11.2007 |
|||||||
30.10.2007 |
Rebetol |
|
EU/1/99/107/001-005 |
5.11.2007 |
|||||||
30.10.2007 |
Nonafact |
|
EU/1/01/186/001-002 |
1.11.2007 |
|||||||
31.10.2007 |
Xyrem |
|
EU/1/05/312/001 |
7.11.2007 |
|||||||
31.10.2007 |
Ammonaps |
|
EU/1/99/120/001-004 |
7.11.2007 |
|||||||
31.10.2007 |
Aldurazyme |
|
EU/1/03/253/001-003 |
7.11.2007 |
|||||||
31.10.2007 |
Fuzeon |
|
EU/1/03/252/001-003 |
7.11.2007 |
|||||||
31.10.2007 |
ADROVANCE |
|
EU/1/06/364/001-009 |
7.11.2007 |
|||||||
31.10.2007 |
Tracleer |
|
EU/1/02/220/001-005 |
7.11.2007 |
|||||||
31.10.2007 |
Alimta |
|
EU/1/04/290/001-002 |
7.11.2007 |
|||||||
31.10.2007 |
BYETTA |
|
EU/1/06/362/001-004 |
7.11.2007 |
— Lift of suspension of a marketing authorization (Article 20 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 |
|||||
15.10.2007 |
Viracept |
|
EU/1/97/054/001 EU/1/97/054/003-005 |
18.10.2007 |
— 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 |
|||||
9.10.2007 |
Poulvac FluFend H5N3 RG |
|
EU/2/06/060/001-002 |
11.10.2007 |
|||||
15.10.2007 |
Purevax FelV |
|
EU/2/00/019/005-007 |
18.10.2007 |
|||||
29.10.2007 |
ProteqFlu Te |
|
EU/2/03/038/005 |
31.10.2007 |
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 136, 30.4.2004, p. 1.