Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology;Oncology, PIP number: P/0107/2023

European Union example instances - E2B(R3) testing files

Test cases (1a-10) RTFs

EudraVigilance - EVWEB user manual

EudraVigilance registration manual

Herbal medicinal product: Foeniculi amari fructus aetheroleumArray, F: Assessment finalised

Clinical Trials Information System (CTIS): Walk-in clinic - July 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 10 July 2024, 16:00 (CEST) to 10 July 2024, 17:00 (CEST)

CHMP PROM minutes for the meeting on 15 April 2024

Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products