| Dawnzera |
Human |
donidalorsen |
donidalorsen sodium |
EMEA/H/C/006554 |
Otsuka Pharmaceutical Netherlands B.V. |
|
Opinion |
| GalenVita |
Human |
germanium (68Ge) chloride;gallium (68Ga) chloride |
germanium (68Ge) chloride;gallium (68Ga) chloride |
EMEA/H/C/006639 |
Curium Romania S.R.L. |
|
Opinion |
| Ondibta |
Human |
insulin glargine |
insulin glargine |
EMEA/H/C/006136 |
Gan & Lee Pharmaceuticals Europe GmbH |
|
Opinion |
| Osqay |
Human |
denosumab |
denosumab |
EMEA/H/C/006492 |
Theramex Ireland Limited |
|
Opinion |
| Teduglutide Viatris |
Human |
teduglutide |
teduglutide |
EMEA/H/C/006564 |
Viatris Limited |
|
Opinion |
| VacPertagen |
Human |
pertussis vaccine (recombinant, acellular, component, adsorbed) |
pertussis filamentous haemagglutinin |
EMEA/H/C/006304 |
BioNet Europe |
|
Opinion |
| Waskyra |
Human |
autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein |
autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein |
EMEA/H/C/006525 |
Fondazione Telethon ETS |
|
Opinion |
| Inluriyo |
Human |
imlunestrant |
imlunestrant tosilate |
EMEA/H/C/006184 |
Eli Lilly Nederland B.V. |
|
Opinion |
| Datopotamab deruxtecan Daiichi Sankyo |
Human |
datopotamab deruxtecan |
datopotamab deruxtecan |
EMEA/H/C/006081 |
Daiichi Sankyo Europe GmbH |
|
Application withdrawn |
| Vaxxinact H5 |
Veterinary |
Avian influenza virus, subtype H5, haemagglutinin (recombinant) |
Avian influenza virus, subtype H5, haemagglutinin (recombinant) |
EMEA/V/C/006717 |
Boehringer Ingelheim Vetmedica GmbH |
|
Opinion |
| Ecovaxxin MS |
Veterinary |
Mycoplasma synoviae, strain K588A, Live |
Mycoplasma synoviae, strain K588A, Live |
EMEA/V/C/006604 |
Eco Animal Health Europe Limited |
|
Opinion |
| Amtagvi |
Human |
lifileucel |
lifileucel |
EMEA/H/C/004741 |
Iovance Biotherapeutics B.V. |
|
Application withdrawn |
| Portela |
Veterinary |
relfovetmab |
relfovetmab |
EMEA/V/C/005890 |
|
|
Authorised |
| Bravecto TriUNO |
Veterinary |
fluralaner;moxidectin;pyrantel |
fluralaner;moxidectin;pyrantel |
EMEA/V/C/006311 |
|
|
Authorised |
| Zurzuvae |
Human |
zuranolone |
zuranolone |
EMEA/H/C/006488 |
Biogen Netherlands B.V. |
|
Authorised |
| Fanskya |
Human |
Mozafancogene autotemcel |
mozafancogene autotemcel |
EMEA/H/C/005537 |
Rocket Pharmaceuticals B.V. |
|
Application withdrawn |
| Insulin Human Rechon |
Human |
insulin human |
Insulin human |
EMEA/H/C/006011 |
Rechon Life Science AB |
|
Application withdrawn |
| MiPet Easecto |
Veterinary |
sarolaner |
sarolaner |
EMEA/V/C/004732 |
|
|
Withdrawn |
| Elevidys |
Human |
delandistrogene moxeparvovec |
delandistrogene moxeparvovec |
EMEA/H/C/005293 |
Roche Registration GmbH |
|
Refused |
| Austedo |
Human |
deutetrabenazine |
deutetrabenazine |
EMEA/H/C/006371 |
Teva GmbH |
|
Opinion |