Orphan designation: 2,4,6,7,8,9-hexahydro-4-((2-methylphenyl)methyl)-7-(phenylmethyl)imidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(1H)-one Treatment of glioma, 18/07/2022 Positive

Human medicines European public assessment report (EPAR): Ngenla, somatrogon, Date of authorisation: 14/02/2022, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Aripiprazole Sandoz, aripiprazole, Date of authorisation: 20/08/2015, Revision: 14, Status: Authorised

Report - Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability

Human medicines European public assessment report (EPAR): Tavneos, avacopan, Date of authorisation: 11/01/2022, Revision: 9, Status: Revoked

Human medicines European public assessment report (EPAR): Oxbryta, voxelotor, Date of authorisation: 14/02/2022, Revision: 7, Status: Suspended

Human medicines European public assessment report (EPAR): Artesunate Amivas, artesunate, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Zilbrysq, zilucoplan, Date of authorisation: 01/12/2023, Revision: 5, Status: Authorised

EMA risk management information day, European Medicines Agency, Amsterdam, the Netherlands, from 8 September 2026, 09:00 (CEST) to 8 September 2026, 17:00 (CEST)

Human medicines European public assessment report (EPAR): Lacosamide UCB, lacosamide, Date of authorisation: 26/08/2019, Revision: 9, Status: Authorised