Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0120/2022

Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Gastroentology-Hepatology, PIP number: P/0038/2022

EMEA-003185-PIP01-22

Human medicines European public assessment report (EPAR): Artesunate Amivas, artesunate, Date of authorisation: 22/11/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Zavicefta, ceftazidime,avibactam, Date of authorisation: 23/06/2016, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Date of authorisation: 17/04/2009, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated,bazedoxifene, Date of authorisation: 16/12/2014, Revision: 17, Status: Authorised

Agenda - PDCO agenda of the 20-23 May 2025 meeting

Electronic product information (ePI)

PSUSA/00002492/202409