| Koselugo |
Human |
selumetinib |
selumetinib sulfate |
EMEA/H/C/005244 |
AstraZeneca AB |
2021/06/17
|
Authorised |
| Onureg |
Human |
azacitidine |
azacitidine |
EMEA/H/C/004761 |
Bristol-Myers Squibb Pharma EEIG |
2021/06/17
|
Authorised |
| Adtralza |
Human |
tralokinumab |
tralokinumab |
EMEA/H/C/005255 |
LEO Pharma A/S |
2021/06/17
|
Authorised |
| Evkeeza |
Human |
evinacumab |
Evinacumab |
EMEA/H/C/005449 |
Ultragenyx Germany GmbH |
2021/06/17
|
Authorised |
| Celsunax |
Human |
ioflupane (123I) |
ioflupane (123i) |
EMEA/H/C/005135 |
Pinax Pharma GmbH |
2021/06/17
|
Authorised |
| Efmody |
Human |
hydrocortisone |
hydrocortisone |
EMEA/H/C/005105 |
Neurocrine Netherlands B.V. |
2021/05/27
|
Authorised |
| Ponvory |
Human |
ponesimod |
ponesimod |
EMEA/H/C/005163 |
Laboratoires Juvisé Pharmaceuticals |
2021/05/19
|
Authorised |
| Copiktra |
Human |
duvelisib |
duvelisib |
EMEA/H/C/005381 |
Secura Bio Limited |
2021/05/19
|
Authorised |
| Lydisilka |
Human |
estetrol;drospirenone |
estetrol monohydrate;drospirenone |
EMEA/H/C/005382 |
Estetra SPRL |
2021/05/19
|
Authorised |
| Drovelis |
Human |
estetrol;drospirenone |
drospirenone;estetrol monohydrate |
EMEA/H/C/005336 |
Gedeon Richter Plc. |
2021/05/19
|
Authorised |
| Sibnayal |
Human |
potassium citrate;potassium hydrogen carbonate |
potassium citrate monohydrated;potassium hydrogen carbonate |
EMEA/H/C/005407 |
Advicenne S.A. |
2021/04/30
|
Authorised |
| Orladeyo |
Human |
berotralstat |
berotralstat dihydrochloride |
EMEA/H/C/005138 |
BioCryst Ireland Limited |
2021/04/30
|
Authorised |
| Abiraterone Accord |
Human |
abiraterone |
abiraterone acetate |
EMEA/H/C/005408 |
Accord Healthcare S.L.U. |
2021/04/26
|
Authorised |
| Abevmy |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005327 |
Biosimilar Collaborations Ireland Limited |
2021/04/21
|
Authorised |
| Jemperli |
Human |
dostarlimab |
dostarlimab |
EMEA/H/C/005204 |
GlaxoSmithKline Trading Services Limited |
2021/04/21
|
Authorised |
| Sogroya |
Human |
somapacitan |
somapacitan |
EMEA/H/C/005030 |
Novo Nordisk A/S |
2021/03/31
|
Authorised |
| Alymsys |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005286 |
Mabxience Research SL |
2021/03/26
|
Authorised |
| Kesimpta |
Human |
ofatumumab |
ofatumumab |
EMEA/H/C/005410 |
Novartis Europharm Limited |
2021/03/26
|
Authorised |
| Vazkepa |
Human |
icosapent ethyl |
Icosapent ethyl |
EMEA/H/C/005398 |
Amarin Pharmaceuticals Ireland Limited |
2021/03/26
|
Authorised |
| Evrysdi |
Human |
risdiplam |
risdiplam |
EMEA/H/C/005145 |
Roche Registration GmbH |
2021/03/26
|
Authorised |