| Evfraxy |
Human |
denosumab |
denosumab |
EMEA/H/C/006526 |
Biosimilar Collaborations Ireland Limited |
2025/06/30
|
Authorised |
| Dazublys |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/006219 |
CuraTeQ Biologics s.r.o |
2025/06/30
|
Authorised |
| Ziihera |
Human |
zanidatamab |
zanidatamab |
EMEA/H/C/006380 |
Jazz Pharmaceuticals Ireland Limited |
2025/06/27
|
Authorised |
| Izamby |
Human |
denosumab |
denosumab |
EMEA/H/C/006152 |
Mabxience Research SL |
2025/06/26
|
Authorised |
| Denbrayce |
Human |
denosumab |
denosumab |
EMEA/H/C/006199 |
Mabxience Research SL |
2025/06/26
|
Authorised |
| Enwylma |
Human |
denosumab |
denosumab |
EMEA/H/C/006376 |
Zentiva k.s. |
2025/06/26
|
Authorised |
| Zadenvi |
Human |
denosumab |
denosumab |
EMEA/H/C/006377 |
Zentiva k.s. |
2025/06/26
|
Authorised |
| Vevzuo |
Human |
denosumab |
denosumab |
EMEA/H/C/006534 |
Biosimilar Collaborations Ireland Limited |
2025/06/25
|
Authorised |
| Yaxwer |
Human |
denosumab |
denosumab |
EMEA/H/C/006437 |
Gedeon Richter Plc. |
2025/06/23
|
Authorised |
| Junod |
Human |
denosumab |
denosumab |
EMEA/H/C/006436 |
Gedeon Richter Plc. |
2025/06/23
|
Authorised |
| Sephience |
Human |
sepiapterin |
sepiapterin |
EMEA/H/C/006331 |
PTC Therapeutics International Limited |
2025/06/19
|
Authorised |
| Tepezza |
Human |
teprotumumab |
teprotumumab |
EMEA/H/C/006396 |
Amgen Europe B.V. |
2025/06/19
|
Authorised |
| Xoanacyl |
Human |
ferric citrate coordination complex |
ferric citrate coordination complex |
EMEA/H/C/006402 |
Averoa |
2025/06/11
|
Authorised |
| Duvyzat |
Human |
givinostat |
givinostat hydrochloride monohydrate |
EMEA/H/C/006079 |
Italfarmaco S.p.A. |
2025/06/06
|
Authorised |
| Qoyvolma |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006649 |
Celltrion Healthcare Hungary Kft. |
2025/06/02
|
Authorised |
| Ryjunea |
Human |
atropine sulfate |
atropine sulfate |
EMEA/H/C/006324 |
Santen Oy |
2025/06/02
|
Authorised |
| Osvyrti |
Human |
denosumab |
denosumab |
EMEA/H/C/006399 |
Accord Healthcare S.L.U. |
2025/05/26
|
Authorised |
| Jubereq |
Human |
denosumab |
denosumab |
EMEA/H/C/006398 |
Accord Healthcare S.L.U. |
2025/05/26
|
Authorised |
| Deqsiga |
Human |
human normal immunoglobulin |
human normal immunoglobulin |
EMEA/H/C/006423 |
Takeda Manufacturing Austria AG |
2025/05/02
|
Authorised |
| Trabectedin Accord |
Human |
trabectedin |
trabectedin |
EMEA/H/C/006433 |
Accord Healthcare S.L.U. |
2025/04/25
|
Authorised |