Timetable: Annual reassessment - ATMP

Timetable: Annual renewal application of conditional marketing authorisation - ATMP

Timetable: Annual renewal application of conditional marketing authorisation - ATMP

Timetable: Marketing authorisation renewal application - ATMP

PSUSA/00001804/202412

Human medicines European public assessment report (EPAR): Nimvastid, rivastigmine, Date of authorisation: 11/05/2009, Revision: 13, Status: Authorised

Orphan designation: Humanised IgG1 monoclonal antibody against human eotaxin-2,nebokitug Treatment of primary sclerosing cholangitis, 21/08/2020 Positive

Orphan designation: Felzartamab Treatment of primary IgA nephropathy, 11/11/2024 Positive

Orphan designation: 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid (satoreotide trixozetan) ,satoreotide trizoxetan gallium (Ga68) Diagnosis of gastro-entero-pancreatic neuroendocrine tumours, 19/02/2014 Positive

Orphan designation: synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues (Vutrisiran) Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis), 25/05/2018 Positive