Timetable: Post-authorisation safety study (PASS) protocols and final results
Submitted by Anonymous (not verified) on 23 September 2025 - 14:29
Timetable: Post-authorisation safety study (PASS) protocols and final results
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
Submitted by Anonymous (not verified) on 23 September 2025 - 14:00
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)
Submitted by Anonymous (not verified) on 23 September 2025 - 13:33
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (22 August 2025 - 18 September 2025)
Submitted by Anonymous (not verified) on 23 September 2025 - 12:53
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (22 August 2025 - 18 September 2025)
Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)
Submitted by Anonymous (not verified) on 23 September 2025 - 12:50
Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)
Engineered living materials for in situ production of therapeutics - EU-IN Horizon Scanning Report
Submitted by Anonymous (not verified) on 23 September 2025 - 12:41
Engineered living materials for in situ production of therapeutics - EU-IN Horizon Scanning Report
New targets for clinical trials in Europe
Submitted by Anonymous (not verified) on 23 September 2025 - 11:55
New targets for clinical trials in Europe
MedDRA important medical event terms list - version 28.1
Submitted by Anonymous (not verified) on 23 September 2025 - 10:14
MedDRA important medical event terms list - version 28.1
Training session on human variations web-based electronic application form (eAF) for CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 September 2025, 10:00 (CEST) to 15 September 2025, 11:30 (CEST)
Submitted by Anonymous (not verified) on 22 September 2025 - 14:16
Training session on human variations web-based electronic application form (eAF) for CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 15 September 2025, 10:00 (CEST) to 15 September 2025, 11:30 (CEST)
New variations guidelines to streamline lifecycle management of medicines
Submitted by Anonymous (not verified) on 22 September 2025 - 13:07
New variations guidelines to streamline lifecycle management of medicines