| Lynozyfic |
Human |
linvoseltamab |
linvoseltamab |
EMEA/H/C/006370 |
Regeneron Ireland Designated Activity Company (DAC) |
2025/04/23
|
Authorised |
| Vyjuvek |
Human |
beremagene geperpavec |
Beremagene geperpavec |
EMEA/H/C/006330 |
Krystal Biotech Netherlands B.V. |
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 |
| Eltrombopag Accord |
Human |
eltrombopag |
eltrombopag olamine |
EMEA/H/C/006459 |
Accord Healthcare S.L.U. |
2025/03/28
|
Authorised |
| Dyrupeg |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/006407 |
CuraTeQ Biologics s.r.o |
2025/03/28
|
Authorised |
| Tivdak |
Human |
tisotumab vedotin |
tisotumab vedotin |
EMEA/H/C/005363 |
Genmab A/S |
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 |
| Yesintek |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006444 |
Biosimilar Collaborations Ireland Limited |
2025/02/14
|
Authorised |
| Avtozma |
Human |
tocilizumab |
tocilizumab |
EMEA/H/C/006196 |
Celltrion Healthcare Hungary Kft. |
2025/02/14
|
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 |
| Emcitate |
Human |
tiratricol |
tiratricol |
EMEA/H/C/005220 |
Rare Thyroid Therapeutics International AB |
2025/02/12
|
Authorised |
| Welireg |
Human |
belzutifan |
belzutifan |
EMEA/H/C/005636 |
Merck Sharp & Dohme B.V. |
2025/02/12
|
Authorised |
| Obodence |
Human |
denosumab |
denosumab |
EMEA/H/C/006424 |
Samsung Bioepis NL B.V. |
2025/02/12
|
Authorised |