Orphan designation: 2,4-Diamino-5-[[5-(1H-pyrazol-5-yl)-2-thienyl]methyl]-1H-pyrimidin-6-one Treatment of hyperphenylalaninaemia, 24/05/2024 Positive
Orphan designation: DNA plasmid containing the COL7A1 gene Treatment of epidermolysis bullosa, 24/05/2024 Positive
Orphan designation: serdexmethylphenidate Treatment of idiopathic hypersomnia, 24/05/2024 Positive
Orphan designation: efineptakin alfa Treatment of acute radiation syndrome, 24/05/2024 Positive
Orphan designation: Adeno-associated virus serotype 9 containing CRISPR/Cas13Y and guide RNA against the human MECP2 gene Treatment of MECP2 duplication syndrome, 24/05/2024 Positive
Minutes of the COMP meeting 18-20 June 2024
Human medicines European public assessment report (EPAR): Tremelimumab AstraZeneca, tremelimumab, Date of authorisation: 20/02/2023, Revision: 1, Status: Withdrawn (authorisation)
Human medicines European public assessment report (EPAR): Cimzia, certolizumab pegol, Date of authorisation: 01/10/2009, Revision: 35, Status: Authorised
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Ninth Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 June 2024, 09:00 (CEST) to 28 June 2024, 13:25 (CEST)