| Xevudy |
Human |
sotrovimab |
sotrovimab |
EMEA/H/C/005676 |
GlaxoSmithKline Trading Services Limited |
2026/02/18
|
Withdrawn |
| Anktiva |
Human |
nogapendekin alfa inbakicept |
nogapendekin alfa inbakicept |
EMEA/H/C/006622 |
Immunitybio Ireland Limited |
2026/02/16
|
Authorised |
| Exdensur |
Human |
depemokimab |
depemokimab |
EMEA/H/C/006446 |
GlaxoSmithKline Trading Services Limited |
2026/02/12
|
Authorised |
| mNexspike |
Human |
COVID-19 mRNA vaccine |
single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding the N-terminal domain and receptor-binding domain of the viral spike (S) protein of SARS-CoV-2 |
EMEA/H/C/006428 |
Moderna Biotech Spain, S.L. |
2026/02/12
|
Authorised |
| Myqorzo |
Human |
aficamten |
aficamten |
EMEA/H/C/006228 |
Cytokinetics (Ireland) Limited |
2026/02/12
|
Authorised |
| Aumseqa |
Human |
Aumolertinib |
Aumolertinib mesilate |
EMEA/H/C/006069 |
SFL Pharmaceuticals Deutschland GmbH |
2026/02/12
|
Authorised |
| Gotenfia |
Human |
golimumab |
golimumab |
EMEA/H/C/006621 |
Stada Arzneimittel AG |
2026/02/10
|
Authorised |
| Ranluspec |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/006502 |
Lupin Europe GmbH |
2026/02/10
|
Authorised |
| Aqneursa |
Human |
L-acetylleucine |
L-acetylleucine |
EMEA/H/C/006327 |
Intrabio Ireland Limited |
2026/01/19
|
Authorised |
| Dawnzera |
Human |
donidalorsen |
donidalorsen |
EMEA/H/C/006554 |
Otsuka Pharmaceutical Netherlands B.V. |
2026/01/19
|
Authorised |
| Waskyra |
Human |
etuvetidigene autotemcel |
genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human Wiskott-Aldrich Syndrome (WAS) gene |
EMEA/H/C/006525 |
Fondazione Telethon ETS |
2026/01/09
|
Authorised |
| VacPertagen |
Human |
pertussis vaccine (recombinant, acellular, component, adsorbed) |
recombinant pertussis toxin;filamentous haemagglutinin |
EMEA/H/C/006304 |
BioNet Europe |
2026/01/09
|
Authorised |
| Inluriyo |
Human |
imlunestrant |
imlunestrant tosilate |
EMEA/H/C/006184 |
Eli Lilly Nederland B.V. |
2026/01/09
|
Authorised |
| Teduglutide Viatris |
Human |
teduglutide |
teduglutide |
EMEA/H/C/006564 |
Viatris Limited |
2026/01/08
|
Authorised |
| Osqay |
Human |
denosumab |
denosumab |
EMEA/H/C/006492 |
Theramex Ireland Limited |
2026/01/08
|
Authorised |
| Teizeild |
Human |
teplizumab |
teplizumab |
EMEA/H/C/005496 |
Sanofi Winthrop Industrie |
2026/01/08
|
Authorised |
| Austedo |
Human |
deutetrabenazine |
deutetrabenazine |
EMEA/H/C/006371 |
Teva GmbH |
2026/01/08
|
Authorised |
| GalenVita |
Human |
germanium (68Ge) chloride;gallium (68Ga) chloride |
germanium (68Ge) chloride;gallium (68Ga) chloride |
EMEA/H/C/006639 |
Curium Romania S.R.L. |
2026/01/08
|
Authorised |
| Wayrilz |
Human |
rilzabrutinib |
rilzabrutinib |
EMEA/H/C/006425 |
Sanofi B.V. |
2025/12/22
|
Authorised |
| Imaavy |
Human |
nipocalimab |
nipocalimab |
EMEA/H/C/006379 |
Janssen Cilag International NV |
2025/11/28
|
Authorised |