Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiac disorders, PIP number: P/0457/2023

Human medicines European public assessment report (EPAR): Dynastat, parecoxib, Date of authorisation: 22/03/2002, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 9, Status: Authorised

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Veterinary medicines European public assessment report (EPAR): Bluevac-3, bluetongue virus vaccine (inactivated), Status: Authorised

Union product database: webinar for veterinary marketing authorisation holders on an industry dedicated read API, Online, from 27 February 2025, 11:00 (CET) to 27 February 2025, 12:00 (CET)

Annex to 24-27 February 2025 CHMP Agenda

Frequently asked questions (FAQs) : How to create and submit an annual safety report and respond to related requests for information - CTIS Training Programme - Module 18

Frequently asked questions (FAQs): How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10

Minutes - PDCO minutes of the 12-15 November 2024 meeting