| Gavreto |
Human |
pralsetinib |
pralsetinib |
EMEA/H/C/005413 |
Blueprint Medicines (Netherlands) B.V. |
2021/11/18
|
Withdrawn |
| Hukyndra |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005548 |
Stada Arzneimittel AG |
2021/11/15
|
Authorised |
| Sugammadex Mylan |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/005403 |
Mylan Pharmaceuticals Limited |
2021/11/15
|
Authorised |
| Vumerity |
Human |
diroximel fumarate |
Diroximel fumarate (BIIB098) |
EMEA/H/C/005437 |
Biogen Netherlands B.V. |
2021/11/15
|
Authorised |
| Libmyris |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005947 |
Stada Arzneimittel AG |
2021/11/12
|
Authorised |
| Rivaroxaban Viatris (previously Rivaroxaban Mylan) |
Human |
rivaroxaban |
rivaroxaban |
EMEA/H/C/005600 |
Viatris Limited |
2021/11/12
|
Authorised |
| Regkirona |
Human |
regdanvimab |
regdanvimab |
EMEA/H/C/005854 |
Celltrion Healthcare Hungary Kft. |
2021/11/12
|
Withdrawn |
| Ronapreve |
Human |
casirivimab;imdevimab |
casirivimab;imdevimab |
EMEA/H/C/005814 |
Roche Registration GmbH |
2021/11/12
|
Authorised |
| Imatinib Koanaa |
Human |
imatinib |
imatinib mesilate |
EMEA/H/C/005595 |
Koanaa Healthcare GmbH |
2021/09/22
|
Withdrawn |
| Ozawade |
Human |
pitolisant |
pitolisant |
EMEA/H/C/005117 |
Bioprojet Pharma |
2021/09/01
|
Authorised |
| Minjuvi |
Human |
tafasitamab |
tafasitamab |
EMEA/H/C/005436 |
Incyte Biosciences Distribution B.V. |
2021/08/26
|
Authorised |
| Voxzogo |
Human |
vosoritide |
vosoritide |
EMEA/H/C/005475 |
BioMarin International Limited |
2021/08/26
|
Authorised |
| Bimzelx |
Human |
bimekizumab |
bimekizumab |
EMEA/H/C/005316 |
UCB Pharma S.A. |
2021/08/20
|
Authorised |
| Abiraterone Mylan |
Human |
abiraterone acetate |
abiraterone acetate |
EMEA/H/C/005368 |
Mylan Pharmaceuticals Limited |
2021/08/20
|
Authorised |
| Abecma |
Human |
idecabtagene vicleucel |
idecabtagene vicleucel |
EMEA/H/C/004662 |
Bristol-Myers Squibb Pharma EEIG |
2021/08/18
|
Authorised |
| Fingolimod Mylan |
Human |
fingolimod |
|
EMEA/H/C/005661 |
Mylan Pharmaceuticals Limited |
2021/08/18
|
Authorised |
| Evrenzo |
Human |
roxadustat |
roxadustat |
EMEA/H/C/004871 |
Astellas Pharma Europe B.V. |
2021/08/18
|
Authorised |
| Byooviz |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/005545 |
Samsung Bioepis NL B.V. |
2021/08/18
|
Authorised |
| Fingolimod Mylan |
Human |
fingolimod |
fingolimod hydrochloride |
EMEA/H/C/005282 |
Mylan Ireland Limited |
2021/08/18
|
Application withdrawn |
| Verquvo |
Human |
vericiguat |
vericiguat |
EMEA/H/C/005319 |
Bayer AG |
2021/07/16
|
Authorised |