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)

Start of procedure: Extension of marketing authorisation (14 November - 11 December 2025)

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025

New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC

New product information wording – Extracts from PRAC recommendations on signals adopted at the 27-30 November 2023 PRAC

Human medicines European public assessment report (EPAR): Coagadex, human coagulation factor X, Date of authorisation: 16/03/2016, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Remicade, infliximab, Date of authorisation: 13/08/1999, Revision: 69, Status: Authorised