Improving efficiency of approval process for new medicines in the EU

EMEA-003059-PIP02-23

EMEA-003154-PIP01-21

EMEA-002850-PIP03-22

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

EMEA-002381-PIP02-23