| Cejemly |
Human |
sugemalimab |
sugemalimab |
EMEA/H/C/006088 |
Cstone Pharmaceuticals Ireland Limited |
2024/07/24
|
Authorised |
| Pomalidomide Krka |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/006314 |
Krka, d.d., Novo mesto |
2024/07/24
|
Authorised |
| Apexelsin |
Human |
paclitaxel |
paclitaxel |
EMEA/H/C/005997 |
Whiteoak Pharmaceutical B.V. |
2024/07/24
|
Authorised |
| Beqvez (previously Durveqtix) |
Human |
fidanacogene elaparvovec |
fidanacogene elaparvovec |
EMEA/H/C/004774 |
Pfizer Europe MA EEIG |
2024/07/24
|
Withdrawn |
| Pomalidomide Zentiva |
Human |
pomalidomide |
Pomalidomide |
EMEA/H/C/006294 |
Zentiva, k.s. |
2024/07/24
|
Authorised |
| Zegalogue |
Human |
dasiglucagon |
dasiglucagon hydrochloride |
EMEA/H/C/006214 |
Novo Nordisk A/S |
2024/07/24
|
Authorised |
| Ixchiq |
Human |
Chikungunya vaccine (live) |
Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated |
EMEA/H/C/005797 |
Valneva Austria GmbH |
2024/06/28
|
Authorised |
| Obgemsa |
Human |
vibegron |
vibegron |
EMEA/H/C/005957 |
Pierre Fabre Medicament |
2024/06/27
|
Authorised |
| Eribulin Baxter |
Human |
eribulin |
Eribulin mesylate |
EMEA/H/C/006191 |
Baxter Holding B.V. |
2024/06/27
|
Authorised |
| Tofidence |
Human |
tocilizumab |
tocilizumab |
EMEA/H/C/005984 |
STADA Arzneimittel AG |
2024/06/20
|
Authorised |
| Wezenla |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006132 |
Amgen Technology (Ireland) UC |
2024/06/20
|
Authorised |
| Fruzaqla |
Human |
fruquintinib |
fruquintinib |
EMEA/H/C/005979 |
Takeda Pharmaceuticals International AG Ireland |
2024/06/20
|
Authorised |
| Truqap |
Human |
capivasertib |
capivasertib |
EMEA/H/C/006017 |
AstraZeneca AB |
2024/06/17
|
Authorised |
| Altuvoct |
Human |
efanesoctocog alfa |
Efanesoctocog alfa |
EMEA/H/C/005968 |
Swedish Orphan Biovitrum AB (publ) |
2024/06/17
|
Authorised |
| Fluenz |
Human |
influenza vaccine (live attenuated, nasal) |
influenza virus A/Victoria/4897/2022 (H1N1)pdm09 - like strain (A/Norway/31694/2022, MEDI 369815), A A/Croatia/10136RV/2023 (H3N2)-like strain (A/Perth/722/2024, MEDI 392611) B/Austria/1359417/2021 - like strain (B/ Austria/1359417/2021, MEDI 355292) |
EMEA/H/C/006514 |
AstraZeneca AB |
2024/06/03
|
Authorised |
| Agilus |
Human |
dantrolene sodium, hemiheptahydrate |
dantrolene sodium, hemiheptahydrate |
EMEA/H/C/006009 |
Norgine B.V. |
2024/05/29
|
Authorised |
| Qalsody |
Human |
tofersen |
tofersen |
EMEA/H/C/005493 |
Biogen Netherlands B.V. |
2024/05/29
|
Authorised |
| Neoatricon |
Human |
dopamine hydrochloride |
dopamine hydrochloride;Dopamine |
EMEA/H/C/006044 |
BrePco Biopharma Limited |
2024/05/27
|
Authorised |
| Lytenava |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005723 |
Outlook Therapeutics Limited |
2024/05/27
|
Authorised |
| Awiqli |
Human |
insulin icodec |
insulin icodec |
EMEA/H/C/005978 |
Novo Nordisk A/S |
2024/05/17
|
Authorised |