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Document 52006XC0930(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006 (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 2006 to 31 August 2006 (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 2006 to 31 August 2006 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
OB C 236, 30.9.2006, p. 2–6
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
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30.9.2006 |
EN |
Official Journal of the European Union |
C 236/2 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2006 to 31 August 2006
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2006/C 236/02)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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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10.8.2006 |
Thelin |
sitaxentan sodium |
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EU/1/06/353/001-005 |
film coated tablet |
Non applicable |
11.8.2006 |
|||||
|
28.8.2006 |
Exjade |
deferasirox |
|
EU/1/06/356/001-006 |
Dispersible tablet |
V03AC03 |
31.8.2006 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
||||||
|
4.8.2006 |
Taxotere |
|
EU/1/95/002/001-002 |
8.8.2006 |
||||||
|
4.8.2006 |
NovoSeven |
|
EU/1/96/006/001-003 |
8.8.2006 |
||||||
|
4.8.2006 |
Hepsera |
|
EU/1/03/251/001 |
8.8.2006 |
||||||
|
4.8.2006 |
HBVAXPRO |
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EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 |
8.8.2006 |
||||||
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4.8.2006 |
HBVAXPRO |
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EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 |
8.8.2006 |
||||||
|
4.8.2006 |
Tasmar |
|
EU/1/97/044/001-008 |
8.8.2006 |
||||||
|
4.8.2006 |
Enbrel |
|
EU/1/99/126/012 |
8.8.2006 |
||||||
|
4.8.2006 |
Mirapexin |
|
EU/1/97/051/001-006 EU/1/97/051009-012 |
8.8.2006 |
||||||
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4.8.2006 |
InductOs |
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EU/1/02/226/001 |
8.8.2006 |
||||||
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7.8.2006 |
Levviax |
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EU/1/01/192/001-005 |
9.8.2006 |
||||||
|
7.8.2006 |
Ketek |
|
EU/1/01/191/001-005 |
9.8.2006 |
||||||
|
7.8.2006 |
Lantus |
|
EU/1/00/134/001-029 |
9.8.2006 |
||||||
|
7.8.2006 |
Optisulin |
|
EU/1/00/133/001-008 |
9.8.2006 |
||||||
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7.8.2006 |
Keppra |
|
EU/1/00/146/001-030 |
9.8.2006 |
||||||
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7.8.2006 |
Fasturtec |
|
EU/1/00/170/001-002 |
9.8.2006 |
||||||
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7.8.2006 |
Zenapax |
|
EU/1/99/098/001-002 |
9.8.2006 |
||||||
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7.8.2006 |
KOGENATE Bayer |
|
EU/1/00/143/001-009 |
9.8.2006 |
||||||
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7.8.2006 |
Xagrid |
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EU/1/04/295/001 |
9.8.2006 |
||||||
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7.8.2006 |
Sifrol |
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EU/1/97/050/001-006 EU/1/97/050/009-012 |
9.8.2006 |
||||||
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7.8.2006 |
Optison |
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EU/1/98/065/001-002 |
9.8.2006 |
||||||
|
10.8.2006 |
Tracleer |
|
EU/1/02/220/001-005 |
14.8.2006 |
||||||
|
10.8.2006 |
Rapilysin |
|
EU/1/96/018/001 |
14.8.206 |
||||||
|
21.8.2006 |
HBVAXPRO |
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EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-029 |
23.8.2006 |
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21.8.2006 |
Ziagen |
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EU/1/99/112/001-002 |
23.8.2006 |
||||||
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21.8.2006 |
NovoSeven |
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EU/1/96/006/001-003 |
23.8.2006 |
||||||
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28.8.2006 |
Bonviva |
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EU/1/03/265/001-006 |
31.8.2006 |
||||||
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28.8.2006 |
Aptivus |
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EU/1/05/315/001 |
31.8.2006 |
||||||
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28.8.2006 |
Twinrix Paediatric |
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EU/1/97/029/001-010 |
31.8.2006 |
||||||
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28.8.2006 |
Twinrix Adult |
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EU/1/96/020/001-009 |
31.8.2006 |
||||||
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28.8.2006 |
Bondenza |
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EU/1/03/266/001-006 |
31.8.2006 |
||||||
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28.8.2006 |
Truvada |
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EU/1/04/305/001 |
31.8.2006 |
||||||
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28.8.2006 |
Vfend |
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EU/1/02/212/001-026 |
31.8.2006 |
||||||
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28.8.2006 |
Inductos |
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EU/1/02/226/001 |
31.8.2006 |
||||||
|
28.8.2006 |
Hepsera |
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EU/1/03/251/001 |
31.8.2006 |
||||||
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28.8.2006 |
Orfadin |
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EU/1/04/303/001-003 |
31.8.2006 |
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28.8.2006 |
Karvezide |
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EU/1/98/085/023-028 |
31.8.2006 |
||||||
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28.8.2006 |
Revatio |
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EU/1/05/318/001 |
1.9.2006 |
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28.8.2006 |
CoAprovel |
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EU/1/98/086/023-028 |
31.8.2006 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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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 |
||||
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10.8.2006 |
Equilis Prequenza |
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EU/2/05/056/003-004 |
14.8.2006 |
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10.8.2006 |
Equilis Prequenza te |
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EU/2/05/057/003-004 |
14.8.2006 |
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21.8.2006 |
Vaxxitek HVT+ IBD |
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EU/2/02/032/001 |
23.8.2006 |
||||
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21.8.2006 |
Naxcel |
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EU/2/05/053/002 |
23.8.2006 |
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 |
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7, Westferry Circus, Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136 of 30.4.2004, p. 1.