| Kuvan |
Human |
sapropterin |
sapropterin dihydrochloride |
EMEA/H/C/000943 |
BioMarin International Limited |
2008/12/02
|
Authorised |
| Ifirmasta (previously Irbesartan Krka) |
Human |
irbesartan |
irbesartan hydrochloride |
EMEA/H/C/000962 |
Krka, d.d., Novo mesto |
2008/12/01
|
Authorised |
| Icandra (previously Vildagliptin / metformin hydrochloride Novartis) |
Human |
vildagliptin;metformin |
vildagliptin;metformin hydrochloride |
EMEA/H/C/001050 |
Novartis Europharm Limited |
2008/11/30
|
Authorised |
| Zomarist |
Human |
vildagliptin;metformin |
vildagliptin;metformin hydrochloride |
EMEA/H/C/001049 |
Novartis Europharm Limited |
2008/11/30
|
Authorised |
| Azarga |
Human |
brinzolamide;timolol |
brinzolamide;timolol maleate |
EMEA/H/C/000960 |
Novartis Europharm Limited |
2008/11/25
|
Authorised |
| Zypadhera |
Human |
olanzapine |
olanzapine pamoate |
EMEA/H/C/000890 |
CHEPLAPHARM Registration GmbH |
2008/11/19
|
Authorised |
| Xiliarx |
Human |
vildagliptin |
vildagliptin |
EMEA/H/C/001051 |
Novartis Europharm Limited |
2008/11/19
|
Authorised |
| Jalra |
Human |
vildagliptin |
vildagliptin |
EMEA/H/C/001048 |
Novartis Europharm Limited |
2008/11/19
|
Authorised |
| Duloxetine Boehringer Ingelheim |
Human |
duloxetine |
duloxetine |
EMEA/H/C/001007 |
Boehringer Ingelheim International GmbH |
2008/10/08
|
Withdrawn |
| Ceplene |
Human |
histamine dihydrochloride |
histamine dihydrochloride |
EMEA/H/C/000796 |
Laboratoires Delbert |
2008/10/07
|
Authorised |
| Olanzapine Viatris (previously Olanzapine Mylan) |
Human |
olanzapine |
olanzapine |
EMEA/H/C/000961 |
Viatris Limited |
2008/10/06
|
Authorised |
| Alisade |
Human |
fluticasone furoate |
fluticasone furoate |
EMEA/H/C/001019 |
Glaxo Group Ltd. |
2008/10/06
|
Lapsed |
| Evicel |
Human |
human fibrinogen;human thrombin |
human fibrinogen;human thrombin |
EMEA/H/C/000898 |
Omrix Biopharmaceuticals N. V. |
2008/10/05
|
Withdrawn |
| Adcirca (previously Tadalafil Lilly) |
Human |
tadalafil |
tadalafil |
EMEA/H/C/001021 |
Eli Lilly Nederland B.V. |
2008/10/01
|
Authorised |
| Xarelto |
Human |
rivaroxaban |
rivaroxaban |
EMEA/H/C/000944 |
Bayer AG |
2008/09/30
|
Authorised |
| Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals |
Human |
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) |
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) |
EMEA/H/C/001015 |
GlaxoSmithKline Biologicals S.A. |
2008/09/26
|
Withdrawn |
| Tevagrastim |
Human |
filgrastim |
filgrastim |
EMEA/H/C/000827 |
Teva GmbH |
2008/09/15
|
Authorised |
| Ratiograstim |
Human |
filgrastim |
filgrastim |
EMEA/H/C/000825 |
Ratiopharm GmbH |
2008/09/15
|
Authorised |
| Biograstim |
Human |
filgrastim |
filgrastim |
EMEA/H/C/000826 |
AbZ-Pharma GmbH |
2008/09/15
|
Withdrawn |
| Filgrastim ratiopharm |
Human |
filgrastim |
filgrastim |
EMEA/H/C/000824 |
Ratiopharm GmbH |
2008/09/15
|
Withdrawn |