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Document 52007XC0727(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 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 June 2007 to 30 June 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 June 2007 to 30 June 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 174, 27.7.2007, p. 3–9
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
27.7.2007 |
EN |
Official Journal of the European Union |
C 174/3 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 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 174/04)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted
|
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 |
||||||
|
1.6.2007 |
Optaflu |
Influenza vaccine (surface antigen, inactivated, prepared in cell culture) |
|
EU/1/07/394/001-006 |
Suspension for injection in pre-filled syringe |
J07BB02 |
5.6.2007 |
||||||
|
14.6.2007 |
Revlimid |
Lenalidomide |
|
EU/1/07/391/001-004 |
Hard capsule |
L04AX04 |
19.6.2007 |
||||||
|
20.6.2007 |
Soliris |
Eculizumab |
|
EU/1/07/393/001 |
Concentrate for solution for infusion |
Non applicable |
22.6.2007 |
||||||
|
25.6.2007 |
Invega |
Paliperidone |
|
EU/1/07/395/001-064 |
Prolonged release tablet |
5N05AX13 |
27.6.2007 |
||||||
|
25.6.2007 |
Pergoveris |
Follitropin alfa/lutropin alfa |
|
EU/1/07/396/001-003 |
Powder and solvent for solution for injection |
G03GA05/G03GA07 |
27.6.2007 |
||||||
|
29.6.2007 |
Circadin |
Melatonin |
|
EU/1/07/392/001 |
Prolonged-release tablet |
N05CM17 |
5.7.2007 |
||||||
|
29.6.2007 |
Siklos |
Hydroxycarbamide |
|
EU/1/07/397/001 |
Film-coated tablet |
L01XX05 |
5.7.2007 |
— 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 |
|||||||
|
1.6.2007 |
Renagel |
|
EU/1/99/123/001-012 |
5.6.2007 |
|||||||
|
1.6.2007 |
Rebetol |
|
EU/1/99/107/001-005 |
5.6.2007 |
|||||||
|
4.6.2007 |
Myocet |
|
EU/1/00/141/001 |
7.6.2007 |
|||||||
|
6.6.2007 |
||||||||||
|
4.6.2007 |
Vasovist |
|
EU/1/05/313/001-009 |
6.6.2007 |
|||||||
|
4.6.2007 |
Aptivus |
|
EU/1/05/315/001 |
6.6.2007 |
|||||||
|
4.6.2007 |
Humira |
|
EU/1/03/256/001-010 |
6.6.2007 |
|||||||
|
4.6.2007 |
Trudexa |
|
EU/1/03/257/001-010 |
6.6.2007 |
|||||||
|
4.6.2007 |
Orgalutran |
|
EU/1/00/130/001-002 |
6.6.2007 |
|||||||
|
4.6.2007 |
TRIZIVIR |
|
EU/1/00/156/002-003 |
6.6.2007 |
|||||||
|
4.6.2007 |
Zometa |
|
EU/1/01/176/001-006 |
6.6.2007 |
|||||||
|
4.6.2007 |
Avandamet |
|
EU/1/03/258/001-022 |
6.6.2007 |
|||||||
|
5.6.2007 |
Azomyr |
|
EU/1/00/157/001-067 |
7.6.2007 |
|||||||
|
5.6.2007 |
Aerius |
|
EU/1/00/160/001-069 |
8.6.2007 |
|||||||
|
5.6.2007 |
Neoclarityn |
|
EU/1/00/161/001-067 |
7.6.2007 |
|||||||
|
5.6.2007 |
Abilify |
|
EU/1/04/276/001-020 EU/1/04/276/024-036 |
7.6.2007 |
|||||||
|
5.6.2007 |
Trisenox |
|
EU/1/02/204/001 |
8.6.2007 |
|||||||
|
7.6.2007 |
||||||||||
|
5.6.2007 |
Visudyne |
|
EU/1/00/140/001 |
7.6.2007 |
|||||||
|
7.6.2007 |
Tracleer |
|
EU/1/02/220/001-005 |
11.6.2007 |
|||||||
|
8.6.2007 |
Levemir |
|
EU/1/04/278/001-009 |
12.6.2007 |
|||||||
|
8.6.2007 |
Vistide |
|
EU/1/97/037/001 |
12.6.2007 |
|||||||
|
13.6.2007 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
15.6.2007 |
|||||||
|
13.6.2007 |
Azopt |
|
EU/1/00/129/001-003 |
15.6.2007 |
|||||||
|
13.6.2007 |
Tracleer |
|
EU/1/02/220/001-005 |
15.6.2007 |
|||||||
|
13.6.2007 |
Gardasil |
|
EU/1/06/357/001-017 |
15.6.2007 |
|||||||
|
13.6.2007 |
Ebixa |
|
EU/1/02/219/001-015 |
15.6.2007 |
|||||||
|
13.6.2007 |
PegIntron |
|
EU/1/00/131/001-050 |
15.6.2007 |
|||||||
|
13.6.2007 |
Silgard |
|
EU/1/06/358/001-017 |
15.6.2007 |
|||||||
|
14.6.2007 |
Rapilysin |
|
EU/1/96/018/001 |
19.6.2007 |
|||||||
|
19.6.2007 |
Zyprexa Velotab |
|
EU/1/99/125/001-016 |
21.6.2007 |
|||||||
|
20.6.2007 |
Axura |
|
EU/1/02/218/001-011 |
25.6.2007 |
|||||||
|
20.6.2007 |
Cialis |
|
EU/1/02/237/001-008 |
21.6.2007 |
|||||||
|
21.6.2007 |
Levemir |
|
EU/1/04/278/001-009 |
25.6.2007 |
|||||||
|
21.6.2007 |
PEGASYS |
|
EU/1/02/221/001-010 |
25.6.2007 |
|||||||
|
21.6.2007 |
Hycamtin |
|
EU/1/96/027/001 EU/1/96/027/003-005 |
25.6.2007 |
|||||||
|
21.6.2007 |
Iscover |
|
EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b EU/1/98/070/005a-005b EU/1/98/070/006a-006b EU/1/98/070/007a-007b |
25.6.2007 |
|||||||
|
21.6.2007 |
Synagis |
|
EU/1/99/117/001-002 |
25.6.2007 |
|||||||
|
21.6.2007 |
Forsteo |
|
EU/1/03/247/001-002 |
25.6.2007 |
|||||||
|
21.6.2007 |
Revasc |
|
EU/1/97/043/001-003 |
25.6.2007 |
|||||||
|
21.6.2007 |
Cystagon |
|
EU/1/97/039/001-004 |
25.6.2007 |
|||||||
|
21.6.2007 |
PEGASYS |
|
EU/1/02/221/001-010 |
25.6.2007 |
|||||||
|
22.6.2007 |
Plavix |
|
EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b |
26.6.2007 |
|||||||
|
25.6.2007 |
M-M-RVAXPRO |
|
EU/1/06/337/001-013 |
27.6.2007 |
|||||||
|
25.6.2007 |
NeoRecormon |
|
EU/1/97/031/001-003 EU/1/97/031/019-046 |
27.6.2007 |
|||||||
|
27.6.2007 |
Vaniqa |
|
EU/1/01/173/001-003 |
29.6.2007 |
|||||||
|
29.6.2007 |
Tamiflu |
|
EU/1/02/222/001-002 |
3.7.2007 |
|||||||
|
29.6.2007 |
Ferriprox |
|
EU/1/99/108/001 |
3.7.2007 |
|||||||
|
3.7.2007 |
||||||||||
|
29.6.2007 |
Humira |
|
EU/1/03/256/001-010 |
5.7.2007 |
|||||||
|
29.6.2007 |
Viramune |
|
EU/1/97/055/001-003 |
5.7.2007 |
|||||||
|
29.6.2007 |
Trudexa |
|
EU/1/03/257/001-010 |
5.7.2007 |
|||||||
|
29.6.2007 |
Prandin |
|
EU/1/00/162/003-006 EU/1/00/162/009-012 EU/1/00/162/015-021 |
5.7.2007 |
|||||||
|
29.6.2007 |
NovoNorm |
|
EU/1/98/076/004-007 EU/1/98/076/011-014 EU/1/98/076/018-024 |
5.7.2007 |
|||||||
|
29.6.2007 |
Tygacil |
|
EU/1/06/336/001 |
5.7.2007 |
|||||||
|
29.6.2007 |
Lyrica |
|
EU/1/04/279/001-035 |
5.7.2007 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted
|
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 |
|||
|
20.6.2007 |
PRILACTONE |
Spironolactone |
|
EU/2/07/074/001-006 |
Tablet |
QC03DA01 |
22.6.2007 |
|||
|
21.6.2007 |
Circovac |
Inactivated porcine circovirus type 2 |
|
EU/2/07/075/001-004 |
Emulsion and suspension for emulsion for injection |
QI09AA07 |
25.6.2007 |
— 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 |
|||
|
14.6.2007 |
Vaxxitek HVT+ IBD |
|
EU/2/02/032/001 |
19.6.2007 |
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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London E14 4HB |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.