| 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Withdrawn |
| Enzalutamide Viatris |
Human |
enzalutamide |
enzalutamide |
EMEA/H/C/006299 |
Viatris Limited |
2024/08/22
|
Authorised |
| mResvia |
Human |
Respiratory syncytial virus mRNA vaccine (nucleoside modified) |
Respiratory syncytial virus mRNA vaccine (nucleoside modified) |
EMEA/H/C/006278 |
Moderna Biotech Spain, S.L. |
2024/08/22
|
Authorised |
| Piasky |
Human |
crovalimab |
|
EMEA/H/C/006061 |
Roche Registration GmbH |
2024/08/22
|
Authorised |
| Steqeyma |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/005918 |
Celltrion Healthcare Hungary Kft. |
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 |
| Winrevair |
Human |
sotatercept |
sotatercept |
EMEA/H/C/005647 |
Merck Sharp & Dohme B.V. |
2024/08/22
|
Authorised |
| Eurneffy |
Human |
epinephrine |
epinephrine |
EMEA/H/C/006139 |
ALK-Abelló A/S |
2024/08/22
|
Authorised |
| Balversa |
Human |
erdafitinib |
Erdafitinib |
EMEA/H/C/006050 |
Janssen-Cilag International N.V. |
2024/08/22
|
Authorised |
| Tauvid |
Human |
flortaucipir (18F) |
Flortaucipir (18F) |
EMEA/H/C/006064 |
Eli Lilly Nederland B.V. |
2024/08/22
|
Authorised |
| Akantior |
Human |
polihexanide |
Polihexanide |
EMEA/H/C/005858 |
SIFI SPA |
2024/08/22
|
Authorised |
| GalliaPharm |
Human |
gallium (68Ga) chloride;germanium (68Ge) chloride |
gallium (68Ga) chloride;germanium (68Ge) chloride |
EMEA/H/C/006053 |
Eckert & Ziegler Radiopharma GmbH |
2024/08/01
|
Authorised |
| Adzynma |
Human |
rADAMTS13 |
rADAMTS13 |
EMEA/H/C/006198 |
Takeda Manufacturing Austria AG |
2024/08/01
|
Authorised |
| Dasatinib Accord Healthcare |
Human |
dasatinib |
Dasatinib monohydrate |
EMEA/H/C/006251 |
Accord Healthcare S.L.U. |
2024/07/26
|
Authorised |
| Pomalidomide Accord |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/006273 |
Accord Healthcare S.L.U. |
2024/07/26
|
Authorised |
| Avzivi |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005574 |
FGK Representative Service GmbH |
2024/07/26
|
Authorised |