| 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 |
Immedica Netherlands B.V. |
2021/05/27
|
Authorised |
| Ponvory |
Human |
ponesimod |
ponesimod |
EMEA/H/C/005163 |
Laboratoires Juvisé Pharmaceuticals |
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 |
| Copiktra |
Human |
duvelisib |
duvelisib |
EMEA/H/C/005381 |
Secura Bio Limited |
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 |
| Jemperli |
Human |
dostarlimab |
dostarlimab |
EMEA/H/C/005204 |
GlaxoSmithKline Trading Services Limited |
2021/04/21
|
Authorised |
| Abevmy |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005327 |
Biosimilar Collaborations Ireland Limited |
2021/04/21
|
Authorised |
| Sogroya |
Human |
somapacitan |
somapacitan |
EMEA/H/C/005030 |
Novo Nordisk A/S |
2021/03/31
|
Authorised |
| Thiotepa Riemser |
Human |
thiotepa |
thiotepa |
EMEA/H/C/005434 |
Esteve Pharmaceuticals GmbH |
2021/03/26
|
Authorised |
| Nexpovio |
Human |
selinexor |
selinexor |
EMEA/H/C/005127 |
Stemline Therapeutics B.V. |
2021/03/26
|
Authorised |
| Evrysdi |
Human |
risdiplam |
risdiplam |
EMEA/H/C/005145 |
Roche Registration GmbH |
2021/03/26
|
Authorised |
| Pemazyre |
Human |
pemigatinib |
pemigatinib |
EMEA/H/C/005266 |
Incyte Biosciences Distribution B.V. |
2021/03/26
|
Authorised |
| Vazkepa |
Human |
icosapent ethyl |
Icosapent ethyl |
EMEA/H/C/005398 |
Recordati Industria Chimica e Farmaceutica S.p.A. |
2021/03/26
|
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 |
| Oyavas |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005556 |
STADA Arzneimittel AG |
2021/03/26
|
Authorised |