Minutes of the CAT meeting 19-21 June 2024

Orphan designation: camrelizumab Treatment of hepatocellular carcinoma, 25/07/2024 Positive

Orphan designation: [(2S,3S,4E,6S,7R,10R)-7,10-dihydroxy-3,7-dimethyl-12-oxo-2-[(2E,4E,6R)-6-pyridin-2-ylhepta-2,4-dien-2-yl]-1-oxacyclododec-4-en-6-yl]4-methylpiperazine-1-carboxylate Treatment of myelodysplastic syndromes, 20/06/2023 Positive

Minutes of the CAT meeting 22-24 May 2024

Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid,trofinetide Treatment of Rett syndrome, 10/08/2015 Positive

UPD registration guide for UI and API users

Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification

Big data training curriculum

Human medicines European public assessment report (EPAR): Zydelig, idelalisib, Date of authorisation: 18/09/2014, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Amyvid, florbetapir (18F), Date of authorisation: 14/01/2013, Revision: 15, Status: Authorised