Opinion/decision on a Paediatric investigation plan (PIP): Ocrevus, ocrelizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMA/PE/0000237224

EMA/PE/0000228372

Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, azilsartan medoxomil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vascular disorders, PIP number: EMA/PE/0000237559

Opinion/decision on a Paediatric investigation plan (PIP): Kerendia, finerenone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: EMA/PE/0000235999

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

EMA/PE/0000235991

EMA/PE/0000238063

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)