Agenda of the CHMP meeting 18-21 May 2026

Human medicines European public assessment report (EPAR): Sapropterin Dipharma, sapropterin, Date of authorisation: 16/02/2022, Revision: 8, Status: Authorised

Orphan designation: orvepitant maleate Treatment of idiopathic pulmonary fibrosis, 21/11/2025 Withdrawn

Orphan designation: 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide Treatment of congenital hyperinsulinism, 09/12/2020 Withdrawn

Orphan designation: serplulimab Treatment of small cell lung cancer, 20/02/2025 Withdrawn

Orphan designation: Dexamethasone sodium phosphate encapsulated in human erythrocytes Treatment of cystic fibrosis, 20/10/2004 Withdrawn

Orphan designation: Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes Treatment of ataxia telangiectasia, 17/07/2013 Withdrawn

Orphan designation: tazemetostat Treatment of diffuse large B-cell lymphoma, 21/03/2018 Withdrawn

Orphan designation: tazemetostat Treatment of malignant mesothelioma, 21/03/2018 Withdrawn

Orphan designation: avenciguat Treatment of systemic sclerosis, 11/11/2024 Withdrawn