| 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 |
| Byooviz |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/005545 |
Samsung Bioepis NL B.V. |
2021/08/18
|
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 |
| Fingolimod Mylan |
Human |
fingolimod |
fingolimod hydrochloride |
EMEA/H/C/005282 |
Mylan Ireland Limited |
2021/08/18
|
Application withdrawn |
| Imcivree |
Human |
setmelanotide |
setmelanotide |
EMEA/H/C/005089 |
Rhythm Pharmaceuticals Netherlands B.V. |
2021/07/16
|
Authorised |
| Verquvo |
Human |
vericiguat |
vericiguat |
EMEA/H/C/005319 |
Bayer AG |
2021/07/16
|
Authorised |
| Icatibant Accord |
Human |
icatibant |
icatibant acetate |
EMEA/H/C/005083 |
Accord Healthcare S.L.U. |
2021/07/16
|
Authorised |
| Klisyri |
Human |
tirbanibulin |
tirbanibulin |
EMEA/H/C/005183 |
Almirall, S.A. |
2021/07/16
|
Authorised |
| Bylvay |
Human |
odevixibat |
odevixibat |
EMEA/H/C/004691 |
Ipsen Pharma |
2021/07/16
|
Authorised |
| Ryeqo |
Human |
relugolix;estradiol;norethisterone acetate |
relugolix;norethisterone acetate;estradiol hemihydrate |
EMEA/H/C/005267 |
Gedeon Richter Plc. |
2021/07/16
|
Authorised |
| Skysona |
Human |
elivaldogene autotemcel |
elivaldogene autotemcel |
EMEA/H/C/003690 |
bluebird bio (Netherlands) B.V. |
2021/07/16
|
Withdrawn |
| Abiraterone Krka |
Human |
abiraterone acetate |
abiraterone acetate |
EMEA/H/C/005649 |
Krka, d.d., Novo mesto |
2021/06/24
|
Authorised |
| Enspryng |
Human |
satralizumab |
satralizumab |
EMEA/H/C/004788 |
Roche Registration GmbH |
2021/06/24
|
Authorised |
| Jayempi |
Human |
azathioprine |
azathioprine |
EMEA/H/C/005055 |
Lipomed GmbH |
2021/06/21
|
Authorised |