| Vyloy |
Human |
zolbetuximab |
zolbetuximab |
EMEA/H/C/005868 |
Astellas Pharma Europe B.V. |
2024/09/19
|
Authorised |
| Tuznue |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/006252 |
Prestige Biopharma Belgium |
2024/09/19
|
Authorised |
| Anzupgo |
Human |
delgocitinib |
Delgocitinib |
EMEA/H/C/006109 |
LEO Pharma A/S |
2024/09/19
|
Authorised |
| Epruvy (previously Ranibizumab Midas) |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/006528 |
Midas Pharma GmbH |
2024/09/19
|
Authorised |
| Axitinib Accord |
Human |
axitinib |
axitinib |
EMEA/H/C/006206 |
Accord Healthcare S.L.U. |
2024/09/19
|
Authorised |
| Iqirvo |
Human |
elafibranor |
Elafibranor |
EMEA/H/C/006231 |
Ipsen Pharma |
2024/09/19
|
Authorised |
| Kayfanda |
Human |
odevixibat |
odevixibat sesquihydrate |
EMEA/H/C/006462 |
Ipsen Pharma |
2024/09/19
|
Authorised |
| Ituxredi |
Human |
rituximab |
rituximab |
EMEA/H/C/006224 |
Reddy Holding GmbH |
2024/09/19
|
Authorised |
| Vevizye |
Human |
ciclosporin |
ciclosporin |
EMEA/H/C/006250 |
Laboratoires Théa |
2024/09/19
|
Authorised |
| Eksunbi |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006448 |
Samsung Bioepis NL B.V. |
2024/09/12
|
Withdrawn |
| mResvia |
Human |
respiratory syncytial virus mRNA vaccine |
Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilised in the prefusion conformation |
EMEA/H/C/006278 |
Moderna Biotech Spain, S.L. |
2024/08/22
|
Authorised |
| Balversa |
Human |
erdafitinib |
Erdafitinib |
EMEA/H/C/006050 |
Janssen-Cilag International N.V. |
2024/08/22
|
Authorised |
| Steqeyma |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/005918 |
Celltrion Healthcare Hungary Kft. |
2024/08/22
|
Authorised |
| Eurneffy |
Human |
epinephrine |
epinephrine |
EMEA/H/C/006139 |
ALK-Abelló A/S |
2024/08/22
|
Authorised |
| Winrevair |
Human |
sotatercept |
sotatercept |
EMEA/H/C/005647 |
Merck Sharp & Dohme B.V. |
2024/08/22
|
Authorised |
| Enzalutamide Viatris |
Human |
enzalutamide |
enzalutamide |
EMEA/H/C/006299 |
Viatris Limited |
2024/08/22
|
Authorised |
| Piasky |
Human |
crovalimab |
Crovalimab |
EMEA/H/C/006061 |
Roche Registration GmbH |
2024/08/22
|
Authorised |
| Tauvid |
Human |
flortaucipir (18F) |
Flortaucipir (18F) |
EMEA/H/C/006064 |
Eli Lilly Nederland B.V. |
2024/08/22
|
Authorised |
| Ordspono |
Human |
odronextamab |
odronextamab |
EMEA/H/C/006215 |
Regeneron Ireland Designated Activity Company (DAC) |
2024/08/22
|
Authorised |
| Nilotinib Accord |
Human |
nilotinib |
nilotinib |
EMEA/H/C/006315 |
Accord Healthcare S.L.U. |
2024/08/22
|
Authorised |