| 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 |
| Imcivree |
Human |
setmelanotide |
setmelanotide |
EMEA/H/C/005089 |
Rhythm Pharmaceuticals Netherlands B.V. |
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Withdrawn |
| Enspryng |
Human |
satralizumab |
satralizumab |
EMEA/H/C/004788 |
Roche Registration GmbH |
2021/06/24
|
Authorised |
| Abiraterone Krka |
Human |
abiraterone acetate |
abiraterone acetate |
EMEA/H/C/005649 |
Krka, d.d., Novo mesto |
2021/06/24
|
Authorised |
| Jayempi |
Human |
azathioprine |
azathioprine |
EMEA/H/C/005055 |
Lipomed GmbH |
2021/06/21
|
Authorised |
| Adtralza |
Human |
tralokinumab |
tralokinumab |
EMEA/H/C/005255 |
LEO Pharma A/S |
2021/06/17
|
Authorised |
| Onureg |
Human |
azacitidine |
azacitidine |
EMEA/H/C/004761 |
Bristol-Myers Squibb Pharma EEIG |
2021/06/17
|
Authorised |
| Evkeeza |
Human |
evinacumab |
Evinacumab |
EMEA/H/C/005449 |
Ultragenyx Germany GmbH |
2021/06/17
|
Authorised |
| Koselugo |
Human |
selumetinib |
selumetinib sulfate |
EMEA/H/C/005244 |
AstraZeneca AB |
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 |