| 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 |
| Qalsody |
Human |
tofersen |
tofersen |
EMEA/H/C/005493 |
Biogen Netherlands B.V. |
2024/05/29
|
Authorised |
| Agilus |
Human |
dantrolene sodium, hemiheptahydrate |
dantrolene sodium, hemiheptahydrate |
EMEA/H/C/006009 |
Norgine B.V. |
2024/05/29
|
Authorised |
| Lytenava |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005723 |
Outlook Therapeutics NL B. V. |
2024/05/27
|
Authorised |
| Neoatricon |
Human |
dopamine hydrochloride |
dopamine hydrochloride;Dopamine |
EMEA/H/C/006044 |
BrePco Biopharma Limited |
2024/05/27
|
Authorised |
| Fabhalta |
Human |
iptacopan |
iptacopan hydrochloride monohydrate |
EMEA/H/C/005764 |
Novartis Europharm Limited |
2024/05/17
|
Authorised |
| Awiqli |
Human |
insulin icodec |
insulin icodec |
EMEA/H/C/005978 |
Novo Nordisk A/S |
2024/05/17
|
Authorised |
| Wyost |
Human |
denosumab |
denosumab |
EMEA/H/C/006378 |
Sandoz GmbH |
2024/05/17
|
Authorised |
| Omlyclo |
Human |
omalizumab |
omalizumab |
EMEA/H/C/005958 |
Celltrion Healthcare Hungary Kft. |
2024/05/16
|
Authorised |
| Jubbonti |
Human |
denosumab |
denosumab |
EMEA/H/C/005964 |
Sandoz GmbH |
2024/05/16
|
Authorised |
| Dimethyl fumarate Mylan |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006397 |
Mylan Pharmaceuticals Limited |
2024/04/22
|
Authorised |
| Emblaveo |
Human |
aztreonam;avibactam |
avibactam;aztreonam |
EMEA/H/C/006113 |
Pfizer Europe MA EEIG |
2024/04/22
|
Authorised |
| Dimethyl fumarate Accord |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006471 |
Accord Healthcare Ltd |
2024/04/22
|
Authorised |
| Dimethyl fumarate Neuraxpharm |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006500 |
Neuraxpharm Pharmaceuticals S.L. |
2024/04/22
|
Authorised |
| Zynyz |
Human |
retifanlimab |
retifanlimab |
EMEA/H/C/006194 |
Incyte Biosciences Distribution B.V. |
2024/04/19
|
Authorised |
| Apremilast Accord |
Human |
apremilast |
apremilast |
EMEA/H/C/006208 |
Accord Healthcare S.L.U. |
2024/04/19
|
Authorised |
| Voydeya |
Human |
danicopan |
danicopan |
EMEA/H/C/005517 |
Alexion Europe SAS |
2024/04/19
|
Authorised |
| Filspari |
Human |
sparsentan |
sparsentan |
EMEA/H/C/005783 |
Vifor France |
2024/04/19
|
Authorised |
| Incellipan |
Human |
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures) |
Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen |
EMEA/H/C/006051 |
Seqirus Netherlands B.V. |
2024/04/19
|
Authorised |
| Pyzchiva |
Human |
ustekinumab |
ustekinumab |
EMEA/H/C/006183 |
Samsung Bioepis NL B.V. |
2024/04/19
|
Authorised |