| Onbrez Breezhaler |
Human |
indacaterol |
indacaterol maleate |
EMEA/H/C/001114 |
Novartis Europharm Limited |
2009/11/29
|
Authorised |
| Irbesartan/Hydrochlorothiazide Teva |
Human |
irbesartan;hydrochlorothiazide |
irbesartan;hydrochlorothiazide |
EMEA/H/C/001112 |
Teva B.V. |
2009/11/26
|
Authorised |
| Multaq |
Human |
dronedarone |
dronedarone |
EMEA/H/C/001043 |
Sanofi Winthrop Industrie |
2009/11/25
|
Authorised |
| Dafiro HCT |
Human |
amlodipine besilate;valsartan;hydrochlorothiazide |
valsartan;hydrochlorothiazide;amlodipine besilate |
EMEA/H/C/001160 |
Novartis Europharm Limited |
2009/11/03
|
Authorised |
| Copalia HCT |
Human |
amlodipine;valsartan;hydrochlorothiazide |
amlodipine;valsartan;hydrochlorothiazide |
EMEA/H/C/001159 |
Novartis Europharm Limited |
2009/11/03
|
Authorised |
| Repaglinide Krka |
Human |
repaglinide |
repaglinide |
EMEA/H/C/001066 |
Krka, d.d., Novo mesto |
2009/11/03
|
Authorised |
| Irbesartan Teva |
Human |
irbesartan |
irbesartan |
EMEA/H/C/001093 |
Teva B.V. |
2009/10/30
|
Authorised |
| Eporatio |
Human |
epoetin theta |
epoetin theta |
EMEA/H/C/001033 |
Ratiopharm GmbH |
2009/10/29
|
Authorised |
| Ilaris |
Human |
canakinumab |
Canakinumab |
EMEA/H/C/001109 |
Novartis Europharm Limited |
2009/10/23
|
Authorised |
| Lamivudine Teva |
Human |
lamivudine |
lamivudine |
EMEA/H/C/001113 |
Teva B.V. |
2009/10/23
|
Authorised |
| Biopoin |
Human |
epoetin theta |
epoetin theta |
EMEA/H/C/001036 |
Teva GmbH |
2009/10/23
|
Authorised |
| Rilonacept Regeneron (previously Arcalyst) |
Human |
rilonacept |
rilonacept |
EMEA/H/C/001047 |
Regeneron UK Limited |
2009/10/23
|
Withdrawn |
| Foclivia |
Human |
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) |
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1) |
EMEA/H/C/001208 |
Seqirus S.r.l. |
2009/10/18
|
Authorised |
| Clopidogrel Viatris (previously Clopidogrel Taw Pharma) |
Human |
clopidogrel |
clopidogrel besilate |
EMEA/H/C/001189 |
Viatris Limited |
2009/10/16
|
Authorised |
| Vantavo (previously Alendronate sodium and colecalciferol, MSD) |
Human |
alendronic acid;colecalciferol |
alendronic acid;colecalciferol |
EMEA/H/C/001180 |
N.V. Organon |
2009/10/16
|
Authorised |
| Pandemic Influenza Vaccine H5N1 Baxter AG |
Human |
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) |
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1) |
EMEA/H/C/001200 |
Resilience Biomanufacturing Ireland Limited |
2009/10/16
|
Withdrawn |
| Exforge HCT |
Human |
amlodipine besilate;valsartan;hydrochlorothiazide |
valsartan;hydrochlorothiazide;amlodipine besilate |
EMEA/H/C/001068 |
Novartis Europharm Limited |
2009/10/15
|
Authorised |
| Imprida HCT |
Human |
amlodipine;valsartan;hydrochlorothiazide |
amlodipine;valsartan;hydrochlorothiazide |
EMEA/H/C/001161 |
Novartis Europharm Ltd. |
2009/10/15
|
Lapsed |
| Resolor |
Human |
prucalopride |
prucalopride succinate |
EMEA/H/C/001012 |
Takeda Pharmaceuticals International AG Ireland |
2009/10/14
|
Authorised |
| Enyglid |
Human |
repaglinide |
repaglinide |
EMEA/H/C/001065 |
Krka, d.d., Novo mesto |
2009/10/13
|
Authorised |