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Document 52007XC0223(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 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 January 2007 to 31 January 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 January 2007 to 31 January 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
SL C 39, 23.2.2007, p. 7–17
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, RO, SK, SL, FI, SV)
|
23.2.2007 |
EN |
Official Journal of the European Union |
C 39/7 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 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 39/09)
— Issuing 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 |
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 |
|||||
|
4.1.2007 |
ADROVANCE |
Alendronate sodium/Colecalciferol |
|
EU/1/06/364/001-005 |
Tablet |
(Non applicable) |
9.1.2007 |
|||||
|
4.1.2007 |
Diacomit |
Stiripentol |
|
EU/1/06/367/001-006 |
Capsule |
N03AX17 |
9.1.2007 |
|||||
|
EU/1/06/367/007-012 |
Powder for oral suspension |
|||||||||||
|
8.1.2007 |
Elaprase |
Idursulfase |
|
EU/1/06/365/001-003 |
Concentrate for solution for infusion |
A16AB09 |
10.1.2007 |
|||||
|
8.1.2007 |
Tandemact |
Pioglitazone/Glimepiride |
|
EU/1/06/366/001-004 |
Tablet |
(Non applicable) |
10.1.2007 |
|||||
|
16.1.2007 |
Inovelon |
rufinamide |
|
EU/1/06/378/001-016 |
Film-coated tablet |
N03AF03 |
18.1.2007 |
|||||
|
16.1.2007 |
Dafiro |
amlodipine/valsartan |
|
EU/1/06/371/001-024 |
Film-coated tablet |
C09DB01 |
18.1.2007 |
|||||
|
16.1.2007 |
Copalia |
amlodipine/valsartan |
|
EU/1/06/372/001-024 |
Film-coated tablet |
C09DB01 |
18.1.2007 |
|||||
|
17.1.2007 |
Exforge |
amlodipine/valsartan |
|
EU/1/06/370/001-024 |
Film-coated tablet |
C09DB01 |
19.1.2007 |
|||||
|
17.1.2007 |
Imprida |
amlodipine/valsartan |
|
EU/1/06/373/001-024 |
Film-coated tablet |
C09DB01 |
19.1.2007 |
|||||
|
17.1.2007 |
Insulin Human Winthrop |
insulin human |
|
EU/1/06/368/001-002 EU/1/06/368/011-015 EU/1/06/368/056-057 |
Solution for injection |
A10AB01 |
2.2.2007 |
|||||
|
EU/1/06/368/003-010 EU/1/06/368/020-024 EU/1/06/368/029-033 EU/1/06/368/038-042 EU/1/06/368/047-051 |
Suspension for injection |
|||||||||||
|
EU/1/06/368/016-019 EU/1/06/368/025-028 EU/1/06/368/034-037 EU/1/06/368/043-046 EU/1/06/368/052-055 |
OptiSet, solution for injection |
|||||||||||
|
19.1.2007 |
Irbesartan BMS |
irbesartan |
|
EU/1/06/375/001-015 |
Tablet |
C09CA04 |
23.1.2007 |
|||||
|
EU/1/06/375/016-033 |
Film-coated tablets |
|||||||||||
|
19.1.2007 |
Irbesartan Hydrochlorothiazide BMS |
irbesartan/hydrochlorothiazide |
|
EU/1/06/369/001-010 |
Tablet |
C09DA04 |
23.1.2007 |
|||||
|
EU/1/06/369/011-028 |
Film-coated tablets |
|||||||||||
|
19.1.2007 |
Irbesartan Winthrop |
Irbesartan |
|
EU/1/06/376/001-015 |
Tablet |
C09CA04 |
23.1.2007 |
|||||
|
EU/1/06/376/016-033 |
Film-coated tablets |
|||||||||||
|
19.1.2007 |
Irbesartan Hydrochlorothiazide Winthrop |
irbesartan/hydrochlorothiazide |
|
EU/1/06/377/001-010 |
Tablet |
C09DA04 |
23.1.2007 |
|||||
|
EU/1/06/377/011-028 |
Film-coated tablets |
|||||||||||
|
22.1.2007 |
Lucentis |
ranibizumab |
|
EU/1/06/374/001 |
Solution for injection |
S01LA04 |
24.1.2007 |
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
|
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 |
|||
|
16.1.2007 |
Thymanax |
|
— |
18.1.2007 |
|||
|
16.1.2007 |
Valdoxan |
|
— |
18.1.2007 |
— 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 |
||||||
|
3.1.2007 |
MicardisPlus |
|
EU/1/02/213/001-016 |
9.1.2007 |
||||||
|
3.1.2007 |
Neulasta |
|
EU/1/02/227/001-003 |
9.1.2007 |
||||||
|
3.1.2007 |
Neupopeg |
|
EU/1/02/228/001-003 |
9.1.2007 |
||||||
|
3.1.2007 |
Invirase |
|
EU/1/96/026/001-002 |
9.1.2007 |
||||||
|
3.1.2007 |
Ceprotin |
|
EU/1/01/190/001-002 |
9.1.2007 |
||||||
|
3.1.2007 |
Ambirix |
|
EU/1/02/224/ 001-005 |
9.1.2007 |
||||||
|
3.1.2007 |
Velcade |
|
EU/1/04/274/001 |
9.1.2007 |
||||||
|
3.1.2007 |
Zostavax |
|
EU/1/06/341/001-013 |
9.1.2007 |
||||||
|
3.1.2007 |
Nexavar |
|
EU/1/06/342/001 |
9.1.2007 |
||||||
|
3.1.2007 |
Telzir |
|
EU/1/04/282/001-002 |
9.1.2007 |
||||||
|
4.1.2007 |
Twinrix Paediatric |
|
EU/1/97/029/001-010 |
9.1.2007 |
||||||
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4.1.2007 |
NovoSeven |
|
EU/1/96/006/001-003 |
9.1.2007 |
||||||
|
4.1.2007 |
PEGASYS |
|
EU/1/02/221/001-010 |
9.1.2007 |
||||||
|
4.1.2007 |
Kinzalmono |
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EU/1/98/091/001-014 |
9.1.2007 |
||||||
|
4.1.2007 |
Twinrix Adult |
|
EU/1/96/020/001-009 |
9.1.2007 |
||||||
|
4.1.2007 |
NeoRecormon |
|
EU/1/97/031/001-003 EU/1/97/031/019-046 |
9.1.2007 |
||||||
|
4.1.2007 |
Micardis |
|
EU/1/98/090/001-020 |
9.1.2007 |
||||||
|
4.1.2007 |
Rebetol |
|
EU/1/99/107/001-005 |
9.1.2007 |
||||||
|
4.1.2007 |
Competact |
|
EU/1/06/354/001-009 |
9.1.2007 |
||||||
|
4.1.2007 |
Remicade |
|
EU/1/99/116/001-003 |
9.1.2007 |
||||||
|
4.1.2007 |
Ketek |
|
EU/1/01/191/001-005 |
9.1.2007 |
||||||
|
4.1.2007 |
Levviax |
|
EU/1/01/192/001-005 |
9.1.2007 |
||||||
|
4.1.2007 |
Temodal |
|
EU/1/98/096/001-008 |
9.1.2007 |
||||||
|
4.1.2007 |
Keppra |
|
EU/1/00/146/001-030 |
10.1.2007 |
||||||
|
4.1.2007 |
Kinzalkomb |
|
EU/1/02/214/001-010 |
9.1.2007 |
||||||
|
8.1.2007 |
PritorPlus |
|
EU/1/02/215/001-014 |
10.1.2007 |
||||||
|
8.1.2007 |
Pritor |
|
EU/1/98/089/001-022 |
10.1.2007 |
||||||
|
8.1.2007 |
DepoCyte |
|
EU/1/01/187/001 |
10.1.2007 |
||||||
|
8.1.2007 |
Agenerase |
|
EU/1/00/148/001-004 |
10.1.2007 |
||||||
|
8.1.2007 |
IntronA |
|
EU/1/99/127/001-044 |
10.1.2007 |
||||||
|
8.1.2007 |
Viread |
|
EU/1/01/200/001 |
10.1.2007 |
||||||
|
9.1.2007 |
Puregon |
|
EU/1/96/008/001-041 |
11.1.2007 |
||||||
|
9.1.2007 |
Neupro |
|
EU/1/05/331/001-037 |
11.1.2007 |
||||||
|
9.1.2007 |
Viraferon |
|
EU/1/99/128/001-037 |
11.1.2007 |
||||||
|
9.1.2007 |
Thyrogen |
|
EU/1/99/122/001-002 |
11.1.2007 |
||||||
|
11.1.2007 |
Karvezide |
|
EU/1/98/085/001-028 |
15.1.2007 |
||||||
|
11.1.2007 |
CoAprovel |
|
EU/1/98/086/001-028 |
15.1.2007 |
||||||
|
11.1.2007 |
Sutent |
|
EU/1/06/347/001-003 |
15.1.2007 |
||||||
|
11.1.2007 |
Viracept |
|
EU/1/97/054/001 EU/1/97/054/003-005 |
15.1.2007 |
||||||
|
11.1.2007 |
Invirase |
|
EU/1/96/026/001-002 |
15.1.2007 |
||||||
|
11.1.2007 |
Karvezide |
|
EU/1/98/085/001-028 |
15.1.2007 |
||||||
|
12.1.2007 |
MabThera |
|
EU/1/98/067/001-002 |
16.1.2007 |
||||||
|
12.1.2007 |
Truvada |
|
EU/1/04/305/001 |
16.1.2007 |
||||||
|
12.1.2007 |
Emtriva |
|
EU/1/03/261/001-003 |
16.1.2007 |
||||||
|
12.1.2007 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-004 |
16.1.2007 |
||||||
|
15.1.2007 |
Stocrin |
|
EU/1/99/111/001-011 |
18.1.2007 |
||||||
|
15.1.2007 |
Viramune |
|
EU/1/97/055/001-003 |
18.1.2007 |
||||||
|
15.1.2007 |
Sustiva |
|
EU/1/99/110/001-009 |
18.1.2007 |
||||||
|
15.1.2007 |
Viread |
|
EU/1/01/200/001 |
18.1.2007 |
||||||
|
16.1.2007 |
Insuman |
|
EU/1/97/030/028-084 |
2.2.2007 |
||||||
|
16.1.2007 |
Kaletra |
|
EU/1/01/172/001-005 |
18.1.2007 |
||||||
|
17.1.2007 |
REYATAZ |
|
EU/1/03/267/001-007 |
19.1.2007 |
||||||
|
17.1.2007 |
Revatio |
|
EU/1/05/318/001 |
19.1.2007 |
||||||
|
17.1.2007 |
SUTENT |
|
EU/1/06/347/001-003 |
19.1.2007 |
||||||
|
17.1.2007 |
Kivexa |
|
EU/1/04/298/001-002 |
19.1.2007 |
||||||
|
17.1.2007 |
Lyrica |
|
EU/1/04/279/001-035 |
19.1.2007 |
||||||
|
17.1.2007 |
Advate |
|
EU/1/03/271/001-004 |
19.1.2007 |
||||||
|
17.1.2007 |
Ziagen |
|
EU/1/99/112/001-002 |
19.1.2007 |
||||||
|
18.1.2007 |
Telzir |
|
EU/1/04/282/001-002 |
22.1.2007 |
||||||
|
18.1.2007 |
Avaglim |
|
EU/1/06/349/001-008 |
22.1.2007 |
||||||
|
18.1.2007 |
Enbrel |
|
EU/1/99/126/001-018 |
22.1.2007 |
||||||
|
19.1.2007 |
Zerit |
|
EU/1/96/009/001-009 |
23.1.2007 |
||||||
|
24.1.2007 |
Stalevo |
|
EU/1/03/260/001-015 |
26.1.2007 |
||||||
|
24.1.2007 |
Paxene |
|
EU/1/99/113/001-004 |
26.1.2007 |
||||||
|
24.1.2007 |
Comtess |
|
EU/1/98/082/001-003 EU/1/98/082/005 |
26.1.2007 |
||||||
|
24.1.2007 |
Fuzeon |
|
EU/1/03/252/001-003 |
26.1.2007 |
||||||
|
24.1.2007 |
TRIZIVIR |
|
EU/1/00/156/002-003 |
26.1.2007 |
||||||
|
24.1.2007 |
Agenerase |
|
EU/1/00/148/001-004 |
26.1.2007 |
||||||
|
24.1.2007 |
Fabrazyme |
|
EU/1/01/188/001-006 |
26.1.2007 |
||||||
|
24.1.2007 |
Tarceva |
|
EU/1/05/311/001-003 |
26.1.2007 |
||||||
|
24.1.2007 |
Avandamet |
|
EU/1/03/258/001-022 |
26.1.2007 |
||||||
|
24.1.2007 |
Aptivus |
|
EU/1/05/315/001 |
26.1.2007 |
||||||
|
24.1.2007 |
Nexavar |
|
EU/1/06/342/001 |
26.1.2007 |
||||||
|
24.1.2007 |
Crixivan |
|
EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 |
26.1.2007 |
||||||
|
25.1.2007 |
Evra |
|
EU/1/02/223/001-003 |
29.1.2007 |
||||||
|
25.1.2007 |
Epivir |
|
EU/1/96/015/001-005 |
29.1.2007 |
||||||
|
26.1.2007 |
Alimta |
|
EU/1/04/290/001 |
30.1.2007 |
||||||
|
26.1.2007 |
Actos |
|
EU/1/00/150/001-024 |
30.1.2007 |
||||||
|
26.1.2007 |
Combivir |
|
EU/1/98/058/001-002 |
30.1.2007 |
||||||
|
26.1.2007 |
Helixate NexGen |
|
EU/1/00/144/001-003 |
30.1.2007 |
||||||
|
26.1.2007 |
TARGRETIN |
|
EU/1/01/178/001 |
30.1.2007 |
||||||
|
29.1.2007 |
KOGENATE Bayer |
|
EU/1/00/143/001-009 |
31.1.2007 |
||||||
|
31.1.2007 |
Avonex |
|
EU/1/97/033/001-003 |
2.2.2007 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
|||
|
9.1.2007 |
Cortavance |
Hydrocortisone aceponate |
|
EU/2/06/069/001 |
Cutaneous spray, solution |
QD07AC |
11.1.2007 |
|||
|
11.1.2007 |
Yposane |
Osaterone acetate |
|
EU/2/06/068/001-004 |
Tablets |
QG04CX |
15.1.2007 |
|||
|
15.1.2007 |
Meloxicam CEVA |
Meloxicam |
|
EU/2/06/070/001-003 |
oral suspension |
QM01AC06 |
18.1.2007 |
— Modification of a marketing authorization (Article 38 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 |
||||
|
4.1.2007 |
Previcox |
|
EU/2/04/045/001-006 |
9.1.2007 |
||||
|
16.1.2007 |
Equilis StrepE |
|
EU/2/04/043/001 |
18.1.2007 |
||||
|
11.1.2007 |
Gonazon |
|
EU/2/03/040/002 |
15.1.2007 |
||||
|
16.1.2007 |
Profender |
|
EU/2/05/054/001-017 |
18.1.2007 |
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.