Summary of opinion: Veklury, 25/04/2025 Positive

Summary of opinion: Calquence, 25/04/2025 Positive

Summary of opinion: Vyvgart, 25/04/2025 Positive

Summary of opinion: Jivi, 25/04/2025 Positive

Summary of opinion: Cystadrops, 25/04/2025 Positive

Human medicines European public assessment report (EPAR): Denosumab BBL, denosumab, Status: Opinion

Orphan designation: (14S)-8-[3-(2-{dispiro[2.0.24.13]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lamba6-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.111,14.05,10]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate, deutivacaftor, tezacaftor Treatment of cystic fibrosis, 12/11/2021 Positive

Orphan designation: Zanidatamab Treatment of biliary tract cancer, 19/07/2021 Positive

Orphan designation: (S)-2-amino-6-(2-hydroxypropanoyl)-7,8-dihydropteridin-4(3H)-one Treatment of hyperphenylalaninemia, 20/05/2021 Positive

Human medicines European public assessment report (EPAR): Dazluma, troriluzole, Status: Application withdrawn