Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide Treatment of meningioma, 06/06/2012 Withdrawn

Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Date of authorisation: 25/04/2016, Revision: 22, Status: Authorised

Orphan designation: (S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo[4',3':1,6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine Treatment of sickle cell disease, 16/03/2022 Withdrawn

Orphan designation: carbetocin Treatment of Prader-Willi syndrome, 21/03/2012 Withdrawn

Orphan designation: Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis(thioether) with (4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,

Orphan designation: 5-fluoro-4-(7'-fluoro-2'-methylspiro[cyclopentane-1,3'-indol]-5'-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine,crozbaciclib Treatment of glioma, 26/03/2021 Withdrawn

Orphan designation: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide Treatment of hepatocellular carcinoma, 23/08/2017 Withdrawn

Orphan designation: Eculizumab Treatment of Guillain-Barré syndrome, 11/10/2022 Withdrawn

Orphan designation: amatuximab Treatment of malignant mesothelioma, 16/01/2014 Withdrawn

Human medicines European public assessment report (EPAR): Krazati, adagrasib, Date of authorisation: 05/01/2024, Revision: 4, Status: Authorised