| Upstaza |
Human |
eladocagene exuparvovec |
Eladocagene exuparvovec |
EMEA/H/C/005352 |
PTC Therapeutics International Limited |
2022/07/18
|
Authorised |
| Zokinvy |
Human |
lonafarnib |
Lonafarnib |
EMEA/H/C/005271 |
TMC Pharma (EU) Limited |
2022/07/18
|
Authorised |
| Sugammadex Fresenius Kabi |
Human |
sugammadex |
sugammadex sodium |
EMEA/H/C/005760 |
Fresenius Kabi Deutschland GmbH |
2022/07/15
|
Authorised |
| Kinpeygo |
Human |
budesonide |
budesonide, micronised |
EMEA/H/C/005653 |
Stada Arzneimittel AG |
2022/07/15
|
Authorised |
| Ertapenem SUN |
Human |
ertapenem |
ertapenem sodium |
EMEA/H/C/005815 |
SUN Pharmaceutical Industries (Europe) B.V. |
2022/07/15
|
Authorised |
| Cevenfacta |
Human |
eptacog beta (activated) |
Eptacog beta (activated) |
EMEA/H/C/005655 |
Laboratoire Francais du Fractionnement et des Biotechnologies |
2022/07/15
|
Authorised |
| Ganirelix Gedeon Richter |
Human |
ganirelix |
ganirelix acetate |
EMEA/H/C/005641 |
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) |
2022/07/15
|
Authorised |
| Nexviadyme |
Human |
avalglucosidase alfa |
avalglucosidase alfa |
EMEA/H/C/005501 |
Sanofi B.V. |
2022/06/24
|
Authorised |
| Xenpozyme |
Human |
olipudase alfa |
olipudase alfa |
EMEA/H/C/004850 |
Sanofi B.V. |
2022/06/24
|
Authorised |
| COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
Human |
COVID-19 vaccine (inactivated, adjuvanted, adsorbed) |
COVID-19 vaccine (inactivated, adjuvanted, adsorbed) |
EMEA/H/C/006019 |
Valneva Austria GmbH |
2022/06/24
|
Withdrawn |
| Filsuvez |
Human |
birch bark extract |
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) |
EMEA/H/C/005035 |
Chiesi Farmaceutici S.p.A |
2022/06/21
|
Authorised |
| Tabrecta |
Human |
capmatinib |
capmatinib dihydrochloride monohydrate |
EMEA/H/C/004845 |
Novartis Europharm Limited |
2022/06/20
|
Authorised |
| Pirfenidone axunio (previously Pirfenidone AET) |
Human |
pirfenidone |
Pirfenidone |
EMEA/H/C/005873 |
Axunio Pharma GmbH |
2022/06/20
|
Authorised |
| Yselty |
Human |
linzagolix choline |
linzagolix choline |
EMEA/H/C/005442 |
Theramex Ireland Limited |
2022/06/14
|
Authorised |
| Lunsumio |
Human |
mosunetuzumab |
mosunetuzumab |
EMEA/H/C/005680 |
Roche Registration GmbH |
2022/06/03
|
Authorised |
| Zolsketil pegylated liposomal |
Human |
doxorubicin |
doxorubicin hydrochloride, liposomal |
EMEA/H/C/005320 |
Accord Healthcare S.L.U. |
2022/05/31
|
Authorised |
| Carvykti |
Human |
ciltacabtagene autoleucel |
ciltacabtagene autoleucel |
EMEA/H/C/005095 |
Janssen-Cilag International NV |
2022/05/25
|
Authorised |
| Camcevi |
Human |
leuprorelin |
leuprorelin mesilate |
EMEA/H/C/005034 |
Accord Healthcare S.L.U. |
2022/05/24
|
Authorised |
| Amifampridine SERB |
Human |
amifampridine |
amifampridine phosphate |
EMEA/H/C/005839 |
SERB SA |
2022/05/19
|
Authorised |
| Dimethyl fumarate Neuraxpharm |
Human |
dimethyl fumarate |
dimethyl fumarate |
EMEA/H/C/006039 |
Laboratorios Lesvi S.L. |
2022/05/13
|
Revoked |