| Attrogy |
Human |
diflunisal |
diflunisal |
EMEA/H/C/006248 |
Purpose Pharma International AB |
2025/07/17
|
Authorised |
| Rolcya |
Human |
denosumab |
denosumab |
EMEA/H/C/006507 |
Sandoz GmbH |
2025/07/17
|
Authorised |
| Bomyntra |
Human |
denosumab |
denosumab |
EMEA/H/C/006269 |
Fresenius Kabi Deutschland GmbH |
2025/07/17
|
Authorised |
| Ezmekly |
Human |
mirdametinib |
mirdametinib |
EMEA/H/C/006460 |
SpringWorks Therapeutics Ireland Limited |
2025/07/17
|
Authorised |
| Aucatzyl |
Human |
obecabtagene autoleucel |
obecabtagene autoleucel |
EMEA/H/C/005907 |
Autolus GmbH |
2025/07/17
|
Authorised |
| Alyftrek |
Human |
deutivacaftor / tezacaftor / vanzacaftor |
deutivacaftor;tezacaftor;vanzacaftor calcium dihydrate |
EMEA/H/C/006382 |
Vertex Pharmaceuticals (Ireland) Limited |
2025/06/30
|
Authorised |
| Oczyesa |
Human |
octreotide |
octreotide hydrochloride |
EMEA/H/C/006322 |
Camurus AB |
2025/06/30
|
Authorised |
| 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 |
| Junod |
Human |
denosumab |
denosumab |
EMEA/H/C/006436 |
Gedeon Richter Plc. |
2025/06/23
|
Authorised |
| Yaxwer |
Human |
denosumab |
denosumab |
EMEA/H/C/006437 |
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 |