| Brinsupri |
Human |
Brensocatib |
Brensocatib monohydrate |
EMEA/H/C/005820 |
Insmed Netherlands B.V. |
2025/11/18
|
Authorised |
| Denosumab Intas |
Human |
denosumab |
denosumab |
EMEA/H/C/006797 |
Intas Third Party Sales 2005 S.L. |
2025/11/17
|
Authorised |
| Lynkuet |
Human |
elinzanetant |
elinzanetant |
EMEA/H/C/006298 |
Bayer AG |
2025/11/17
|
Authorised |
| Usgena |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006667 |
Stada Arzneimittel AG |
2025/11/17
|
Authorised |
| Gobivaz |
Human |
golimumab |
Golimumab |
EMEA/H/C/006560 |
Advanz Pharma Limited |
2025/11/17
|
Authorised |
| Kisunla |
Human |
donanemab |
donanemab |
EMEA/H/C/006024 |
Eli Lilly Nederland B.V. |
2025/09/24
|
Authorised |
| Tryngolza |
Human |
olezarsen |
olezarsen sodium |
EMEA/H/C/006477 |
Swedish Orphan Biovitrum AB (publ) |
2025/09/17
|
Authorised |
| Bilprevda |
Human |
denosumab |
denosumab |
EMEA/H/C/006435 |
Sciencepharma Sp. z o.o |
2025/09/17
|
Authorised |
| Bildyos |
Human |
denosumab |
denosumab |
EMEA/H/C/006434 |
Sciencepharma Sp. z o.o |
2025/09/17
|
Authorised |
| Ekterly |
Human |
sebetralstat |
sebetralstat |
EMEA/H/C/006211 |
Kalvista Pharmaceuticals (Ireland) Limited |
2025/09/17
|
Authorised |
| Usrenty |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006794 |
Biosimilar Collaborations Ireland Limited |
2025/09/17
|
Authorised |
| Voranigo |
Human |
vorasidenib |
vorasidenib |
EMEA/H/C/006284 |
Les Laboratoires Servier |
2025/09/17
|
Authorised |
| Romvimza |
Human |
vimseltinib |
vimseltinib dihydrate |
EMEA/H/C/006363 |
Deciphera Pharmaceuticals (Netherlands) B.V. |
2025/09/17
|
Authorised |
| Eyluxvi |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006282 |
Biolitec pharma Limited Zweigniederlassung Jena |
2025/09/15
|
Authorised |
| Zemcelpro |
Human |
allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel |
allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel |
EMEA/H/C/005772 |
Cordex Biologics International Limited |
2025/08/25
|
Authorised |
| Yeytuo |
Human |
lenacapavir |
lenacapavir sodium |
EMEA/H/C/006658 |
Gilead Sciences Ireland Unlimited Company |
2025/08/25
|
Authorised |
| Nintedanib Viatris |
Human |
nintedanib |
nintedanib |
EMEA/H/C/006486 |
Viatris Limited |
2025/08/22
|
Authorised |
| Imreplys |
Human |
sargramostim |
sargramostim |
EMEA/H/C/006411 |
Partner Therapeutics Limited |
2025/08/21
|
Authorised |
| Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris |
Human |
emtricitabine;rilpivirine;tenofovir alafenamide |
emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide fumarate |
EMEA/H/C/006491 |
Viatris Limited |
2025/08/19
|
Authorised |
| Afiveg |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006761 |
STADA Arzneimittel AG |
2025/08/18
|
Authorised |