| Siiltibcy |
Human |
Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10) |
Mycobacterium tuberculosis derived antigens (rdESAT‑6 and rCFP‑10) |
EMEA/H/C/006177 |
Serum Life Science Europe GmbH |
2025/01/13
|
Authorised |
| Augtyro |
Human |
repotrectinib |
repotrectinib |
EMEA/H/C/006005 |
Bristol-Myers Squibb Pharma EEIG |
2025/01/13
|
Authorised |
| Buprenorphine Neuraxpharm |
Human |
buprenorphine |
buprenorphine hydrochloride |
EMEA/H/C/006188 |
Neuraxpharm Pharmaceuticals S.L. |
2024/12/19
|
Authorised |
| Alhemo |
Human |
concizumab |
concizumab |
EMEA/H/C/005938 |
Novo Nordisk A/S |
2024/12/13
|
Authorised |
| Imuldosa |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006221 |
Accord Healthcare S.L.U. |
2024/12/12
|
Authorised |
| Eltrombopag Viatris |
Human |
eltrombopag |
eltrombopag olamine |
EMEA/H/C/006417 |
Viatris Limited |
2024/12/12
|
Authorised |
| Absimky |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006585 |
Accord Healthcare S.L.U. |
2024/12/12
|
Withdrawn |
| Theralugand |
Human |
lutetium (177Lu) chloride |
lutetium (177Lu) chloride |
EMEA/H/C/005882 |
Eckert & Ziegler Radiopharma GmbH |
2024/11/22
|
Authorised |
| Hympavzi |
Human |
marstacimab |
marstacimab |
EMEA/H/C/006240 |
Pfizer Europe MA EEIG |
2024/11/18
|
Authorised |
| Flucelvax |
Human |
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / A/District of Columbia/27/2023 (H3N2)-like strain (A/Victoria/800/2024 CVR-289) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021) |
EMEA/H/C/006532 |
Seqirus Netherlands B.V. |
2024/11/15
|
Authorised |
| Fluad |
Human |
influenza vaccine (surface antigen, inactivated, adjuvanted) |
A/Victoria/4897/2022 (H1N1)pdm09 like strain (A/Victoria/4897/2022, IVR-238);A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A);B/Austria/1359417/2021 like strain (B/Austria/1359417/2021, BVR-26) |
EMEA/H/C/006538 |
Seqirus Netherlands B.V. |
2024/11/15
|
Authorised |
| Pomalidomide Teva |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/006302 |
Teva GmbH |
2024/11/14
|
Authorised |
| Elahere |
Human |
mirvetuximab soravtansine |
mirvetuximab soravtansine |
EMEA/H/C/005036 |
AbbVie Deutschland GmbH & Co. KG |
2024/11/14
|
Authorised |
| Penbraya |
Human |
meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed) |
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group B fHBP protein subfamily A;Neisseria meningitidis group B fHBP protein subfamily B |
EMEA/H/C/006165 |
Pfizer Europe MA EEIG |
2024/11/14
|
Withdrawn |
| Afqlir |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006150 |
Sandoz GmbH |
2024/11/13
|
Authorised |
| Opuviz |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006056 |
Samsung Bioepis NL B.V. |
2024/11/13
|
Authorised |
| Yuvanci |
Human |
macitentan;tadalafil |
macitentan;tadalafil |
EMEA/H/C/005001 |
Janssen-Cilag International NV |
2024/09/27
|
Authorised |
| Otulfi |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006544 |
Fresenius Kabi Deutschland GmbH |
2024/09/25
|
Authorised |
| Fymskina |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/005805 |
Formycon AG |
2024/09/25
|
Authorised |
| Loqtorzi |
Human |
toripalimab |
toripalimab |
EMEA/H/C/006120 |
Topalliance Biosciences Europe Limited |
2024/09/19
|
Authorised |