List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Date of authorisation: 13/03/1997, Revision: 41, Status: Authorised

Human medicines European public assessment report (EPAR): Pomalidomide Zentiva, pomalidomide, Date of authorisation: 24/07/2024, Revision: 2, Status: Authorised

Medicinal products for human use: monthly figures - April 2026

EU recommendations for 2026/2027 seasonal flu vaccine composition

Orphan designation: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib) Treatment of biliary tract cancer, 01/04/2019 Withdrawn

Orphan designation: S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid Treatment of primary sclerosing cholangitis, 16/10/2017 Withdrawn

Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) Treatment of sickle cell disease, 09/08/2012 Withdrawn

Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt Treatment of acute myeloid leukaemia, 23/03/2009 Withdrawn

Orphan designation: 5-Methyl-pyridine-2-sulfonic acid{6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-[2-(1H-tetrazol-5-yl)-pyridin-4-yl]-pyrimidin-4-yl}-amide sodium salt Treatment of aneurysmal subarachnoid haemorrhage, 12/12/2003 Withdrawn