Opinion/decision on a Paediatric investigation plan (PIP): Palynziq, Pegvaliase, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0241/2024

EMEA-002535-PIP03-19-M01

Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0239/2024

Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan, Regadenoson, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiac disorders, PIP number: P/0238/2024

Human medicines European public assessment report (EPAR): Cotellic, cobimetinib, Date of authorisation: 20/11/2015, Revision: 16, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0236/2024

EMA/HMA annual data forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 December 2025, 09:30 (CET) to 9 December 2025, 17:30 (CET)

Sixth EMA/HMA Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 9 December 2025, 09:30 (CET) to 9 December 2025, 17:30 (CET)

Opinion/decision on a Paediatric investigation plan (PIP): Reagila, cariprazine hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Psychiatric disorders, PIP number: P/0235/2024

EMEA-002432-PIP02-20-M01