Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa, Ceftolozane,tazobactam, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0552/2022

Questions and Answers on how to use a CEP in the context of a Marketing Authorisation Application or a Marketing Authorisation Variation

Opinion/decision on a Paediatric investigation plan (PIP): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0018/2023

Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), PIP number: P/0028/2023

List of industry subject matter experts and list of planned calls for industry subject matter experts

Applications for new human medicines under evaluation: February 2024

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - February 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 February 2024, 10:00 (CET) to 20 February 2024, 12:00 (CET)

Human medicines European public assessment report (EPAR): Voraxaze, glucarpidase, Date of authorisation: 11/01/2022, Revision: 1, Status: Authorised

Committee on Herbal Medicinal Products (HMPC): Work Plan 2024

Joint HMA/EMA multi-stakeholder workshop on Patient Registries