EMEA-003253-PIP01-22-M01

Guide to CTIS training material catalogue

EMEA-003607-PIP01-24

Orphan designation: tasimelteon Treatment of non-24-hour sleep-wake disorders in blind people with no light perception, 23/02/2011 Expired

Clinical Trial Information System (CTIS) structured data form - Notifications, Annual Safety Report (ASR) and results

Minutes of the HMPC meeting 5-7 May 2025

Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)

Clinical Trial Information System (CTIS) - Sponsor handbook

Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 1 July 2025, 10:00 (CEST) to 1 July 2025, 11:30 (CEST)

Human medicines European public assessment report (EPAR): Ituxredi, rituximab, Date of authorisation: 19/09/2024, Revision: 1, Status: Authorised