Kayfanda |
Human |
odevixibat |
Odevixibat sesquihydrate |
EMEA/H/C/006462 |
Ipsen Pharma |
2024/09/19
|
Authorised |
Iqirvo |
Human |
Elafibranor |
Elafibranor |
EMEA/H/C/006231 |
Ipsen Pharma |
2024/09/19
|
Authorised |
Eksunbi |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006448 |
Samsung Bioepis NL B.V. |
2024/09/12
|
Authorised |
Piasky |
Human |
Crovalimab |
|
EMEA/H/C/006061 |
Roche Registration GmbH |
2024/08/22
|
Authorised |
Eurneffy |
Human |
epinephrine |
epinephrine |
EMEA/H/C/006139 |
Ars Pharmaceuticals Irl Limited |
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 |
Ordspono |
Human |
Odronextamab |
Odronextamab |
EMEA/H/C/006215 |
Regeneron Ireland Designated Activity Company (DAC) |
2024/08/22
|
Authorised |
Enzalutamide Viatris |
Human |
enzalutamide |
enzalutamide |
EMEA/H/C/006299 |
Viatris Limited |
2024/08/22
|
Authorised |
Steqeyma |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/005918 |
Celltrion Healthcare Hungary Kft. |
2024/08/22
|
Authorised |
Winrevair |
Human |
Sotatercept |
sotatercept |
EMEA/H/C/005647 |
Merck Sharp & Dohme B.V. |
2024/08/22
|
Authorised |
Nilotinib Accord |
Human |
nilotinib |
nilotinib |
EMEA/H/C/006315 |
Accord Healthcare S.L.U. |
2024/08/22
|
Authorised |
mResvia |
Human |
Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation |
Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized 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 |
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 |
apadamtase alfa;cinaxadamtase alfa |
EMEA/H/C/006198 |
Takeda Manufacturing Austria AG |
2024/08/01
|
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 |
Dasatinib Accord Healthcare |
Human |
dasatinib |
Dasatinib monohydrate |
EMEA/H/C/006251 |
Accord Healthcare S.L.U. |
2024/07/26
|
Authorised |
Cejemly |
Human |
sugemalimab |
Sugemalimab |
EMEA/H/C/006088 |
SFL Pharmaceuticals Deutschland GmbH |
2024/07/24
|
Authorised |