EMEA-002438-PIP04-23

EMEA-002451-PIP03-22

Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neurology, PIP number: P/0298/2023

Opinion/decision on a Paediatric investigation plan (PIP): Wegovy, semaglutide, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0296/2023

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: Immunology-Rheumatology-Transplantation, PIP number: P/0308/2023

Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation: 21/08/2020, Revision: 24, Status: Authorised

EMEA-002381-PIP02-23

Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Other, PIP number: P/0334/2023

Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0297/2023

Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0339/2023