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Document 52007XC0427(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2007 to 31 March 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 March 2007 to 31 March 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 March 2007 to 31 March 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 92, 27.4.2007, p. 15–21
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, RO, SK, SL, FI, SV)
|
27.4.2007 |
EN |
Official Journal of the European Union |
C 92/15 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2007 to 31 March 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 92/15)
— 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 |
|||||
|
21.3.2007 |
Daronrix |
A/Viet Nam/1194/2004 (H5N1) whole virus inactivated antigen |
|
EU/1/06/381/001-008 |
Suspension for injection |
J07BB01 |
23.3.2007 |
|||||
|
21.3.2007 |
Xelevia |
sitagliptin |
|
EU/1/07/382/001-018 |
Film-coated tablets |
A10BH01 |
23.3.2007 |
|||||
|
21.3.2007 |
Januvia |
sitagliptin |
|
EU/1/07/383/001-018 |
Film-coated tablets |
A10BH01 |
23.3.2007 |
— 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 |
|||||||
|
1.3.2007 |
Kinzalmono |
|
EU/1/98/091/001-014 |
5.3.2007 |
|||||||
|
1.3.2007 |
Epivir |
|
EU/1/96/015/001-005 |
5.3.2007 |
|||||||
|
1.3.2007 |
Xyrem |
|
EU/1/05/312/001 |
5.3.2007 |
|||||||
|
1.3.2007 |
Integrilin |
|
EU/1/99/109/001-002 |
5.3.2007 |
|||||||
|
1.3.2007 |
PEGASYS |
|
EU/1/02/221/001-010 |
5.3.2007 |
|||||||
|
1.3.2007 |
Truvada |
|
EU/1/04/305/001 |
5.3.2007 |
|||||||
|
1.3.2007 |
Travatan |
|
EU/1/01/199/001-002 |
5.3.2007 |
|||||||
|
5.3.2007 |
Kinzalkomb |
|
EU/1/02/214/001-010 |
7.3.2007 |
|||||||
|
5.3.2007 |
MicardisPlus |
|
EU/1/02/213/001-016 |
7.3.2007 |
|||||||
|
5.3.2007 |
Humira |
|
EU/1/03/256/001-010 |
7.3.2007 |
|||||||
|
5.3.2007 |
NovoSeven |
|
EU/1/96/006/001-003 |
8.3.2007 |
|||||||
|
5.3.2007 |
Trudexa |
|
EU/1/03/257/001-010 |
7.3.2007 |
|||||||
|
5.3.2007 |
Metalyse |
|
EU/1/00/169/004-006 |
7.3.2007 |
|||||||
|
5.3.2007 |
Refludan |
|
EU/1/97/035/001-004 |
7.3.2007 |
|||||||
|
5.3.2007 |
Micardis |
|
EU/1/98/090/001-020 |
7.3.2007 |
|||||||
|
5.3.2007 |
Corlentor |
|
EU/1/05/317/001-014 |
7.3.2007 |
|||||||
|
6.3.2007 |
Aprovel |
|
EU/1/97/046/001-033 |
8.3.2007 |
|||||||
|
6.3.2007 |
Karvea |
|
EU/1/97/049/001-033 |
8.3.2007 |
|||||||
|
6.3.2007 |
Procolaran |
|
EU/1/05/316/001-014 |
8.3.2007 |
|||||||
|
6.3.2007 |
Bondronat |
|
EU/1/96/012/004 EU/1/96/012/009-013 |
8.3.2007 |
|||||||
|
6.3.2007 |
Onsenal |
|
EU/1/03/259/001-006 |
8.3.2007 |
|||||||
|
7.3.2007 |
Angiox |
|
EU/1/04/289/001-002 |
9.3.2007 |
|||||||
|
9.3.2007 |
Prevenar |
|
EU/1/00/167/001-007 |
13.3.2007 |
|||||||
|
9.3.2007 |
Savene |
|
EU/1/06/350/001 |
13.3.2007 |
|||||||
|
9.3.2007 |
Herceptin |
|
EU/1/00/145/001 |
13.3.2007 |
|||||||
|
14.3.2007 |
Synagis |
|
EU/1/99/117/001-002 |
16.3.2007 |
|||||||
|
14.3.2007 |
Alimta |
|
EU/1/04/290/001 |
16.3.2007 |
|||||||
|
14.3.2007 |
Liprolog |
|
EU/1/01/195/001-015 |
16.3.2007 |
|||||||
|
14.3.2007 |
Vasovist |
|
EU/1/05/313/001-009 |
16.3.2007 |
|||||||
|
20.3.2007 |
Kineret |
|
EU/1/02/203/001-004 |
22.3.2007 |
|||||||
|
20.3.2007 |
GONAL-f |
|
EU/1/95/001/033-035 |
23.3.2007 |
|||||||
|
21.3.2007 |
Aptivus |
|
EU/1/05/315/001 |
23.3.2007 |
|||||||
|
21.3.2007 |
Invanz |
|
EU/1/02/216/001-002 |
23.3.2007 |
|||||||
|
23.3.2007 |
Emselex |
|
EU/1/04/294/001-028 |
27.3.2007 |
|||||||
|
27.3.2007 |
Zimulti |
|
EU/1/06/345/001-009 |
29.3.2007 |
|||||||
|
27.3.2007 |
ACOMPLIA |
|
EU/1/06/344/001-009 |
29.3.2007 |
|||||||
|
27.3.2007 |
Emtriva |
|
EU/1/03/261/001-003 |
29.3.2007 |
|||||||
|
27.3.2007 |
Avastin |
|
EU/1/04/300/001-002 |
29.3.2007 |
|||||||
|
27.3.2007 |
Mabthera |
|
EU/1/98/067/001-002 |
29.3.2007 |
|||||||
|
27.3.2007 |
Remicade |
|
EU/1/99/116/001-003 |
29.3.2007 |
|||||||
|
27.3.2007 |
Liprolog |
|
EU/1/01/195/001-015 |
29.3.2007 |
|||||||
|
27.3.2007 |
REYATAZ |
|
EU/1/03/267/001-007 |
29.3.2007 |
|||||||
|
27.3.2007 |
Optruma |
|
EU/1/98/074/001-004 |
30.3.2007 |
|||||||
|
28.3.2007 |
Xagrid |
|
EU/1/04/295/001 |
30.3.2007 |
|||||||
|
28.3.2007 |
Xeloda |
|
EU/1/00/163/001-002 |
30.3.2007 |
|||||||
|
28.3.2007 |
Kaletra |
|
EU/1/01/172/001-005 |
30.3.2007 |
|||||||
|
28.3.2007 |
Rebif |
|
EU/1/98/063/001-007 |
30.3.2007 |
|||||||
|
28.3.2007 |
Evista |
|
EU/1/98/073/001-004 |
30.3.2007 |
|||||||
|
28.3.2007 |
Glivec |
|
EU/1/01/198/001-013 |
30.3.2007 |
|||||||
|
28.3.2007 |
NeuroBloc |
|
EU/1/00/166/001-003 |
30.3.2007 |
|||||||
|
28.3.2007 |
Zonegran |
|
EU/1/04/307/001-013 |
30.3.2007 |
|||||||
|
28.3.2007 |
Tamiflu |
|
EU/1/02/222/001-002 |
30.3.2007 |
|||||||
|
28.3.2007 |
Humalog |
|
EU/1/96/007/002 EU/1/96/007/004 EU/1/96/007/011 EU/1/96/007/015 EU/1/96/007/020-021 EU/1/96/007/023 EU/1/96/007/026 |
30.3.2007 |
|||||||
|
29.3.2007 |
Humalog |
|
EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-030 |
2.4.2007 |
|||||||
|
29.3.2007 |
Dynastat |
|
EU/1/02/209/001-008 |
2.4.2007 |
|||||||
|
29.3.2007 |
DaTSCAN |
|
EU/1/00/135/001-002 |
2.4.2007 |
|||||||
|
29.3.2007 |
InductOs |
|
EU/1/02/226/001 |
2.4.2007 |
|||||||
|
29.3.2007 |
Betaferon |
|
EU/1/95/003/003-006 |
2.4.2007 |
|||||||
|
29.3.2007 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-012 |
4.4.2007 |
|||||||
|
29.3.2007 |
Invirase |
|
EU/1/96/026/001-002 |
2.4.2007 |
|||||||
|
29.3.2007 |
Revatio |
|
EU/1/05/318/001 |
4.4.2007 |
— 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 |
||||
|
14.3.2007 |
Previcox |
|
EU/2/04/045/007 |
16.3.2007 |
||||
|
14.3.2007 |
Nobivac Piro |
|
EU/2/04/046/001-003 |
16.3.2007 |
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 |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.