Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0267/2023

EMEA-001821-PIP01-15-M07

EMEA-001624-PIP01-14-M06

Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0276/2023

Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0257/2023

Opinion/decision on a Paediatric investigation plan (PIP): Imlygic, talimogene laherparepvec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0275/2023

Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0049/2023

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0258/2023

Human medicines European public assessment report (EPAR): Palynziq, pegvaliase, Date of authorisation: 03/05/2019, Revision: 8, Status: Authorised

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024