EMEA-003522-PIP01-23
EMEA-003522-PIP01-23
EMEA-003522-PIP01-23
Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0049/2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 February 2025, 10:00 (CET) to 26 February 2025, 12:00 (CET)
Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification
Day 80 assessment report - Non-clinical template with guidance Rev. 03.25 - Revamp
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026
Streamlining development and assessment of biosimilar medicines
Reflection paper on a tailored clinical approach in biosimilar development
Reflection paper on a tailored clinical approach in biosimilar development
Human medicines European public assessment report (EPAR): Evista, raloxifene, Date of authorisation: 05/08/1998, Revision: 31, Status: Authorised