| Rayvow |
Human |
lasmiditan |
lasmiditan succinate |
EMEA/H/C/005332 |
Eli Lilly Nederland B.V. |
2022/08/17
|
Authorised |
| Vegzelma |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005534 |
Celltrion Healthcare Hungary Kft. |
2022/08/17
|
Authorised |
| Sunlenca |
Human |
lenacapavir |
lenacapavir sodium |
EMEA/H/C/005638 |
Gilead Sciences Ireland Unlimited Company |
2022/08/17
|
Authorised |
| Pepaxti |
Human |
melphalan flufenamide |
Melphalan flufenamide hydrochloride |
EMEA/H/C/005681 |
Oncopeptides AB (publ) |
2022/08/17
|
Authorised |
| Vyvgart |
Human |
efgartigimod alfa |
Efgartigimod alfa |
EMEA/H/C/005849 |
Argenx |
2022/08/10
|
Authorised |
| Sitagliptin / Metformin hydrochloride Accord |
Human |
sitagliptin;metformin hydrochloride |
metformin hydrochloride;sitagliptin hydrochloride monohydrate |
EMEA/H/C/005850 |
Accord Healthcare S.L.U. |
2022/07/22
|
Lapsed |
| 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 |
| Xenpozyme |
Human |
olipudase alfa |
olipudase alfa |
EMEA/H/C/004850 |
Sanofi B.V. |
2022/06/24
|
Authorised |
| Nexviadyme |
Human |
avalglucosidase alfa |
avalglucosidase alfa |
EMEA/H/C/005501 |
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Withdrawn |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 |
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