| Jakavi |
Human |
ruxolitinib |
ruxolitinib phosphate |
EMEA/H/C/002464 |
Novartis Europharm Limited |
2012/08/23
|
Authorised |
| Zyclara |
Human |
imiquimod |
imiquimod |
EMEA/H/C/002387 |
Viatris Healthcare Limited |
2012/08/23
|
Authorised |
| Cuprymina |
Human |
copper (64Cu) chloride |
copper (64Cu) chloride |
EMEA/H/C/002136 |
A.C.O.M. - Advanced Center Oncology |
2012/08/23
|
Authorised |
| Zinforo |
Human |
ceftaroline fosamil |
ceftaroline fosamil |
EMEA/H/C/002252 |
Pfizer Ireland Pharmaceuticals |
2012/08/22
|
Authorised |
| Zoledronic acid Teva |
Human |
zoledronic acid |
zoledronic acid |
EMEA/H/C/002439 |
Teva B.V. |
2012/08/16
|
Authorised |
| Zoledronic acid Teva Pharma |
Human |
zoledronic acid |
zoledronic acid |
EMEA/H/C/002437 |
Teva B.V. |
2012/08/15
|
Withdrawn |
| Zoledronic acid medac |
Human |
zoledronic acid |
zoledronic acid monohydrate |
EMEA/H/C/002359 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2012/08/03
|
Authorised |
| Fycompa |
Human |
perampanel |
perampanel |
EMEA/H/C/002434 |
Eisai GmbH |
2012/07/23
|
Authorised |
| Kalydeco |
Human |
ivacaftor |
ivacaftor |
EMEA/H/C/002494 |
Vertex Pharmaceuticals (Ireland) Limited |
2012/07/23
|
Authorised |
| Eklira Genuair |
Human |
aclidinium bromide |
aclidinium bromide |
EMEA/H/C/002211 |
Covis Pharma Europe B.V. |
2012/07/20
|
Authorised |
| Bretaris Genuair |
Human |
aclidinium bromide |
aclidinium bromide |
EMEA/H/C/002706 |
Covis Pharma Europe B.V. |
2012/07/20
|
Authorised |
| Jentadueto |
Human |
linagliptin;metformin hydrochloride |
linagliptin;metformin |
EMEA/H/C/002279 |
Boehringer Ingelheim International GmbH |
2012/07/19
|
Authorised |
| Rienso |
Human |
ferumoxytol |
Ferumoxytol |
EMEA/H/C/002215 |
Takeda Pharma A/S |
2012/06/15
|
Withdrawn |
| Docetaxel Kabi |
Human |
docetaxel |
docetaxel |
EMEA/H/C/002325 |
Fresenius Kabi Deutschland GmbH |
2012/05/22
|
Authorised |
| Docetaxel Accord |
Human |
docetaxel |
docetaxel |
EMEA/H/C/002539 |
Accord Healthcare S.L.U. |
2012/05/22
|
Authorised |
| Pixuvri |
Human |
pixantrone dimaleate |
pixantrone dimaleate |
EMEA/H/C/002055 |
Les Laboratoires Servier |
2012/05/10
|
Expired |
| Riluzole Zentiva |
Human |
riluzole |
riluzole |
EMEA/H/C/002622 |
Zentiva k.s. |
2012/05/07
|
Authorised |
| Signifor |
Human |
pasireotide |
pasireotide |
EMEA/H/C/002052 |
Recordati Rare Diseases |
2012/04/24
|
Authorised |
| Capecitabine Teva |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002362 |
Teva Pharma B.V. |
2012/04/20
|
Authorised |
| Ecansya (previously Capecitabine Krka) |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002605 |
Krka, d.d., Novo mesto |
2012/04/20
|
Authorised |