Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines

Human medicines European public assessment report (EPAR): Iqirvo, elafibranor, Date of authorisation: 19/09/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Jubereq, denosumab, Date of authorisation: 26/05/2025, Status: Authorised

Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)

Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)

SPOR and XEVMPD status update webinar, Broadcast, from 9 July 2025, 10:00 (CEST) to 9 July 2025, 12:30 (CEST)

Questions & Answers extract - SPOR and XEVMPD status update webinar 9 July 2025

Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Date of authorisation: 13/11/2013, Revision: 16, Status: Authorised

Procurement

Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions