Pazenir

EMEA-002818-PIP01-20-M01

Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 28 November 2025, 09:00 (CET) to 28 November 2025, 13:00 (CET)

Opinion/decision on a Paediatric investigation plan (PIP): Vydura, rimegepant, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0320/2024

Opinion/decision on a Paediatric investigation plan (PIP): Velsipity, etrasimod, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0321/2024

Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, pegcetacoplan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: P/0348/2024

EMEA-002535-PIP04-21-M02

Human medicines European public assessment report (EPAR): Tryngolza, olezarsen, Date of authorisation: 17/09/2025, Status: Authorised

Human medicines European public assessment report (EPAR): Izamby, denosumab, Date of authorisation: 26/06/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Mynzepli, aflibercept, Date of authorisation: 18/08/2025, Status: Authorised