EMA/PE/0000221424
Submitted by Anonymous (not verified) on 16 December 2025 - 10:54
EMA/PE/0000221424
EMA/PE/0000221424
EMA/PE/0000221500
EMA/PE/0000221511
EMA/PE/0000221664
EMA/PE/0000221674
EMA/PE/0000221695
EMA/PE/0000221772
EMA/PE/0000221419
Human medicines European public assessment report (EPAR): Libmeldy, autologous CD34+ cells encoding ARSA gene, Date of authorisation: 17/12/2020, Revision: 9, Status: Authorised
Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (14 November - 11 December 2025)