Opinion/decision on a Paediatric investigation plan (PIP): Nexviadyme, avalglucosidase alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000238632

Variations requiring assessment (veterinary medicines)

Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandbox, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 September 2026, 13:30 (CEST) to 21 September 2026, 17:00 (CEST)

Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, tofacitinib citrate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMA/PE/0000226763

Meeting of the HMA-EMA group focused on AI with industry stakeholders - June 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, 2 June 2026

EMA/PE/0000236669

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

EMA/PE/0000238977

Opinion/decision on a Paediatric investigation plan (PIP): Idefirix, imlifidase, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Renal and urinary disorders, PIP number: EMEA-002183-PIP03-23

Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Date of authorisation: 16/07/1997, Revision: 35, Status: Authorised