Opinion/decision on a Paediatric investigation plan (PIP): Bimervax, SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion homodimer - XBB.1.16-XBB.1.16 variant,SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0253/2024

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

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