Vyjuvek |
Human |
beremagene geperpavec |
Beremagene geperpavec |
EMEA/H/C/006330 |
Krystal Biotech Netherlands B.V. |
2025/04/23
|
Authorised |
Lynozyfic |
Human |
linvoseltamab |
linvoseltamab |
EMEA/H/C/006370 |
Regeneron Ireland Designated Activity Company (DAC) |
2025/04/23
|
Authorised |
Leqembi |
Human |
Lecanemab |
Lecanemab |
EMEA/H/C/005966 |
Eisai GmbH |
2025/04/15
|
Authorised |
Datroway |
Human |
datopotamab deruxtecan |
datopotamab deruxtecan |
EMEA/H/C/006547 |
Daiichi Sankyo Europe GmbH |
2025/04/04
|
Authorised |
Dyrupeg |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/006407 |
CuraTeQ Biologics s.r.o |
2025/03/28
|
Authorised |
Eltrombopag Accord |
Human |
eltrombopag |
eltrombopag olamine |
EMEA/H/C/006459 |
Accord Healthcare S.L.U. |
2025/03/28
|
Authorised |
Tivdak |
Human |
tisotumab vedotin |
tisotumab vedotin |
EMEA/H/C/005363 |
Pfizer Europe MA EEIG |
2025/03/28
|
Authorised |
Capvaxive |
Human |
pneumococcal polysaccharide conjugate vaccine (21-valent) |
pneumococcal polysaccharide serotype 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B conjugated to CRM197 carrier protein |
EMEA/H/C/006267 |
Merck Sharp & Dohme B.V. |
2025/03/24
|
Authorised |
Rytelo |
Human |
imetelstat |
imetelstat |
EMEA/H/C/006105 |
Geron Netherlands B.V. |
2025/03/07
|
Authorised |
Wainzua |
Human |
eplontersen |
eplontersen sodium |
EMEA/H/C/006295 |
AstraZeneca AB |
2025/03/06
|
Authorised |
Tuzulby |
Human |
methylphenidate hydrochloride |
methylphenidate hydrochloride |
EMEA/H/C/005975 |
Neuraxpharm Pharmaceuticals S.L. |
2025/02/28
|
Authorised |
Vimkunya |
Human |
Chikungunya vaccine (recombinant, adsorbed) |
Chikungunya virus (CHIKV) virus-like particle (VLP) proteins (capsid protein (C) and envelope proteins E1 and E2) derived from CHIKV Senegal strain 37997 produced in human embryonic kidney cells by recombinant DNA technology, adsorbed on aluminium hydroxide, hydrated |
EMEA/H/C/005470 |
Bavarian Nordic A/S |
2025/02/28
|
Authorised |
Paxneury |
Human |
guanfacine |
guanfacine hydrochloride |
EMEA/H/C/006312 |
Neuraxpharm Pharmaceuticals S.L. |
2025/02/26
|
Authorised |
Stoboclo |
Human |
denosumab |
denosumab |
EMEA/H/C/006156 |
Celltrion Healthcare Hungary Kft. |
2025/02/14
|
Authorised |
Osenvelt |
Human |
denosumab |
denosumab |
EMEA/H/C/006157 |
Celltrion Healthcare Hungary Kft. |
2025/02/14
|
Authorised |
Avtozma |
Human |
tocilizumab |
tocilizumab |
EMEA/H/C/006196 |
Celltrion Healthcare Hungary Kft. |
2025/02/14
|
Authorised |
Yesintek |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006444 |
Biosimilar Collaborations Ireland Limited |
2025/02/14
|
Authorised |
Obodence |
Human |
denosumab |
denosumab |
EMEA/H/C/006424 |
Samsung Bioepis NL B.V. |
2025/02/12
|
Authorised |
Zefylti |
Human |
filgrastim |
filgrastim |
EMEA/H/C/006400 |
CuraTeQ Biologics s.r.o |
2025/02/12
|
Authorised |
Eydenzelt |
Human |
aflibercept |
aflibercept |
EMEA/H/C/005899 |
Celltrion Healthcare Hungary Kft. |
2025/02/12
|
Authorised |