| Cibinqo |
Human |
abrocitinib |
abrocitinib |
EMEA/H/C/005452 |
Pfizer Europe MA EEIG |
2021/12/09
|
Authorised |
| Sitagliptin SUN |
Human |
sitagliptin fumarate |
sitagliptin fumarate |
EMEA/H/C/005741 |
Sun Pharmaceutical Industries Europe B.V. |
2021/12/09
|
Authorised |
| Rybrevant |
Human |
amivantamab |
amivantamab |
EMEA/H/C/005454 |
Janssen-Cilag International N.V. |
2021/12/09
|
Authorised |
| Artesunate Amivas |
Human |
artesunate |
artesunate |
EMEA/H/C/005550 |
Amivas Ireland Ltd |
2021/11/22
|
Authorised |
| Brukinsa |
Human |
zanubrutinib |
zanubrutinib |
EMEA/H/C/004978 |
BeOne Medicines Ireland Limited |
2021/11/22
|
Authorised |
| Trodelvy |
Human |
sacituzumab govitecan |
sacituzumab govitecan |
EMEA/H/C/005182 |
Gilead Sciences Ireland UC |
2021/11/22
|
Authorised |
| Qinlock |
Human |
ripretinib |
ripretinib |
EMEA/H/C/005614 |
Deciphera Pharmaceuticals (Netherlands) B.V. |
2021/11/18
|
Authorised |
| 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Withdrawn |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 |
| Ronapreve |
Human |
casirivimab;imdevimab |
casirivimab;imdevimab |
EMEA/H/C/005814 |
Roche Registration GmbH |
2021/11/12
|
Withdrawn |
| 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Withdrawn |
| 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Withdrawn |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 |