| Gotenfia |
Human |
golimumab |
golimumab |
EMEA/H/C/006621 |
Stada Arzneimittel AG |
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 |
| Ondibta |
Human |
insulin glargine |
insulin glargine |
EMEA/H/C/006136 |
Gan & Lee Pharmaceuticals Europe GmbH |
2026/01/09
|
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 |
| 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 |
| Teduglutide Viatris |
Human |
teduglutide |
teduglutide |
EMEA/H/C/006564 |
Viatris Limited |
2026/01/08
|
Authorised |
| Teizeild |
Human |
teplizumab |
teplizumab |
EMEA/H/C/005496 |
Sanofi Winthrop Industrie |
2026/01/08
|
Authorised |
| Osqay |
Human |
denosumab |
denosumab |
EMEA/H/C/006492 |
Theramex Ireland Limited |
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 |
| Kyinsu |
Human |
insulin icodec;semaglutide |
insulin icodec;semaglutide |
EMEA/H/C/006279 |
Novo Nordisk A/S |
2025/11/24
|
Authorised |
| Rivaroxaban Koanaa |
Human |
rivaroxaban |
rivaroxaban |
EMEA/H/C/006643 |
Koanaa Healthcare GmbH |
2025/11/21
|
Authorised |
| Brinsupri |
Human |
Brensocatib |
Brensocatib monohydrate |
EMEA/H/C/005820 |
Insmed Netherlands B.V. |
2025/11/18
|
Authorised |
| Xbonzy |
Human |
denosumab |
denosumab |
EMEA/H/C/006722 |
Reddy Holding GmbH |
2025/11/17
|
Authorised |
| Ponlimsi |
Human |
denosumab |
denosumab |
EMEA/H/C/006238 |
Teva GmbH |
2025/11/17
|
Authorised |
| Degevma |
Human |
denosumab |
denosumab |
EMEA/H/C/006239 |
Teva GmbH |
2025/11/17
|
Authorised |