| Bevespi Aerosphere |
Human |
glycopyrronium;formoterol fumarate dihydrate |
glycopyrronium;formoterol fumarate dihydrate |
EMEA/H/C/004245 |
AstraZeneca AB |
2018/12/18
|
Authorised |
| Flucelvax Tetra |
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/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) |
EMEA/H/C/004814 |
Seqirus Netherlands B.V. |
2018/12/12
|
Withdrawn |
| Ogivri |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/004916 |
Biosimilar Collaborations Ireland Limited |
2018/12/12
|
Authorised |
| Dengvaxia |
Human |
dengue tetravalent vaccine (live, attenuated) |
chimeric yellow fever dengue virus serotype 1 (live, attenuated);chimeric yellow fever dengue virus serotype 2 (live, attenuated);chimeric yellow fever dengue virus serotype 3 (live, attenuated);chimeric yellow fever dengue virus serotype 4 (live, attenuated) |
EMEA/H/C/004171 |
Sanofi Winthrop Industrie |
2018/12/12
|
Withdrawn |
| Ziextenzo |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004802 |
Sandoz GmbH |
2018/11/22
|
Authorised |
| Luxturna |
Human |
voretigene neparvovec |
voretigene neparvovec |
EMEA/H/C/004451 |
Novartis Europharm Limited |
2018/11/22
|
Authorised |
| Poteligeo |
Human |
mogamulizumab |
mogamulizumab |
EMEA/H/C/004232 |
Kyowa Kirin Holdings B.V. |
2018/11/22
|
Authorised |
| Pifeltro |
Human |
doravirine |
doravirine |
EMEA/H/C/004747 |
Merck Sharp & Dohme B.V. |
2018/11/22
|
Authorised |
| Jivi |
Human |
damoctocog alfa pegol |
Damoctocog alfa pegol |
EMEA/H/C/004054 |
Bayer AG |
2018/11/22
|
Authorised |
| Delstrigo |
Human |
doravirine;lamivudine;tenofovir disoproxil |
doravirine;lamivudine;tenofovir disoproxil fumarate |
EMEA/H/C/004746 |
Merck Sharp & Dohme B.V. |
2018/11/22
|
Authorised |
| Takhzyro |
Human |
lanadelumab |
lanadelumab |
EMEA/H/C/004806 |
Takeda Pharmaceuticals International AG Ireland Branch |
2018/11/22
|
Authorised |
| Alunbrig |
Human |
brigatinib |
brigatinib |
EMEA/H/C/004248 |
Takeda Pharma A/S |
2018/11/22
|
Authorised |
| Vaborem |
Human |
meropenem;vaborbactam |
meropenem trihydrate;vaborbactam |
EMEA/H/C/004669 |
Menarini International Operations Luxembourg S.A. |
2018/11/20
|
Authorised |
| Pelmeg |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004700 |
Mundipharma Corporation (Ireland) Limited |
2018/11/20
|
Authorised |
| Fulphila |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/004915 |
Biosimilar Collaborations Ireland Limited |
2018/11/20
|
Authorised |
| Buvidal |
Human |
buprenorphine |
buprenorphine |
EMEA/H/C/004651 |
Camurus AB |
2018/11/20
|
Authorised |
| Apealea |
Human |
paclitaxel |
paclitaxel |
EMEA/H/C/004154 |
Inceptua AB |
2018/11/20
|
Withdrawn |
| Emgality |
Human |
galcanezumab |
Galcanezumab |
EMEA/H/C/004648 |
Eli Lilly Nederland B.V. |
2018/11/14
|
Authorised |
| Symkevi |
Human |
tezacaftor;ivacaftor |
tezacaftor;ivacaftor |
EMEA/H/C/004682 |
Vertex Pharmaceuticals (Ireland) Limited |
2018/10/31
|
Authorised |
| Gefitinib Mylan |
Human |
gefitinib |
gefitinib |
EMEA/H/C/004826 |
Mylan Pharmaceuticals Limited |
2018/09/27
|
Withdrawn |