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
Human medicines European public assessment report (EPAR): Libmeldy, autologous CD34+ cells encoding ARSA gene, Date of authorisation: 17/12/2020, Revision: 7, Status: Authorised
Procurement
Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions
Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop
Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion