| Sugammadex Amomed |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/005935 |
AOP Orphan Pharmaceuticals GmbH |
2023/01/10
|
Authorised |
| Pirfenidone Viatris |
Human |
pirfenidone |
Pirfenidone |
EMEA/H/C/005862 |
Viatris Limited |
2023/01/10
|
Authorised |
| Zynlonta |
Human |
loncastuximab tesirine |
loncastuximab tesirine |
EMEA/H/C/005685 |
Swedish Orphan Biovitrum AB |
2022/12/20
|
Authorised |
| Ebvallo |
Human |
tabelecleucel |
tabelecleucel |
EMEA/H/C/004577 |
Pierre Fabre Medicament |
2022/12/16
|
Authorised |
| Plerixafor Accord |
Human |
plerixafor |
Plerixafor |
EMEA/H/C/005943 |
Accord Healthcare S.L.U. |
2022/12/16
|
Authorised |
| Eladynos |
Human |
abaloparatide |
abaloparatide |
EMEA/H/C/005928 |
Theramex Ireland Limited |
2022/12/12
|
Authorised |
| Dimethyl fumarate Teva |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/005963 |
Teva GmbH |
2022/12/12
|
Revoked |
| Pluvicto |
Human |
lutetium (177Lu) vipivotide tetraxetan |
lutetium (177Lu) vipivotide tetraxetan |
EMEA/H/C/005483 |
Novartis Europharm Limited |
2022/12/09
|
Authorised |
| Locametz |
Human |
gozetotide |
gozetotide |
EMEA/H/C/005488 |
Novartis Europharm Limited |
2022/12/09
|
Authorised |
| Livmarli |
Human |
maralixibat chloride |
Maralixibat chloride |
EMEA/H/C/005857 |
Mirum Pharmaceuticals International B.V. |
2022/12/09
|
Authorised |
| Spevigo |
Human |
spesolimab |
spesolimab |
EMEA/H/C/005874 |
Boehringer Ingelheim International GmbH |
2022/12/09
|
Authorised |
| Pemetrexed Baxter |
Human |
pemetrexed |
pemetrexed disodium heptahydrate |
EMEA/H/C/005848 |
Baxter Holding B.V. |
2022/12/09
|
Authorised |
| Qdenga |
Human |
dengue tetravalent vaccine (live, attenuated) |
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated;Dengue virus, serotype 2, live, attenuated |
EMEA/H/C/005155 |
Takeda GmbH |
2022/12/05
|
Authorised |
| Mycapssa |
Human |
octreotide |
octreotide acetate |
EMEA/H/C/005826 |
Amryt Pharmaceuticals DAC |
2022/12/02
|
Withdrawn |
| Teriparatide Sun |
Human |
teriparatide |
teriparatide |
EMEA/H/C/005793 |
Sun Pharmaceutical Industries Europe B.V. |
2022/11/18
|
Authorised |
| Enjaymo |
Human |
sutimlimab |
sutimlimab |
EMEA/H/C/005776 |
Recordati Rare Diseases |
2022/11/15
|
Authorised |
| VidPrevtyn Beta |
Human |
COVID-19 Vaccine (recombinant, adjuvanted) |
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain) |
EMEA/H/C/005754 |
Sanofi Pasteur |
2022/11/10
|
Withdrawn |
| Livtencity |
Human |
maribavir |
Maribavir |
EMEA/H/C/005787 |
Takeda Pharmaceuticals International AG Ireland Branch |
2022/11/09
|
Authorised |
| Sorafenib Accord |
Human |
sorafenib |
sorafenib tosilate |
EMEA/H/C/005921 |
Accord Healthcare S.L.U. |
2022/11/09
|
Authorised |
| Teriflunomide Viatris (previously Teriflunomide Mylan) |
Human |
teriflunomide |
teriflunomide |
EMEA/H/C/005962 |
Viatris Limited |
2022/11/09
|
Authorised |