PSUSA/00002893/202602
PSUSA/00002893/202602
PSUSA/00002893/202602
PSUSA/00001532/202602
PSUSA/00002152/202602
PSUSA/00000230/202602
Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Date of authorisation: 30/11/2009, Revision: 21, Status: Withdrawn
Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide Treatment of microscopic polyangiitis (avacopan), 19/11/2014 Withdrawn
Orphan designation: Treatment of granulomatosis with polyangiitis, 19/11/2014 Withdrawn
Human medicines European public assessment report (EPAR): Tavneos, avacopan, Date of authorisation: 11/01/2022, Revision: 9, Status: Revoked
Orphan designation: olezarsen sodium Treatment of familial chylomicronaemia syndrome, 21/08/2024 Withdrawn
Human medicines European public assessment report (EPAR): Tryngolza, olezarsen, Date of authorisation: 17/09/2025, Revision: 1, Status: Authorised