| 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 |
| 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 |
| Yesintek |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006444 |
Biosimilar Collaborations Ireland Limited |
2025/02/14
|
Authorised |
| Osenvelt |
Human |
denosumab |
denosumab |
EMEA/H/C/006157 |
Celltrion Healthcare Hungary Kft. |
2025/02/14
|
Authorised |
| Kostaive |
Human |
zapomeran |
COVID-19 sa-mRNA Vaccine |
EMEA/H/C/006207 |
Seqirus Netherlands B.V. |
2025/02/12
|
Authorised |
| Nemluvio |
Human |
nemolizumab |
nemolizumab |
EMEA/H/C/006149 |
Galderma International |
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 |
| Eydenzelt |
Human |
aflibercept |
aflibercept |
EMEA/H/C/005899 |
Celltrion Healthcare Hungary Kft. |
2025/02/12
|
Authorised |
| Zefylti |
Human |
filgrastim |
filgrastim |
EMEA/H/C/006400 |
CuraTeQ Biologics s.r.o |
2025/02/12
|
Authorised |
| Xbryk |
Human |
denosumab |
denosumab |
EMEA/H/C/006468 |
Samsung Bioepis NL B.V. |
2025/02/12
|
Authorised |
| Emcitate |
Human |
tiratricol |
tiratricol |
EMEA/H/C/005220 |
Rare Thyroid Therapeutics International AB |
2025/02/12
|
Authorised |