Article 57 product data

List of eligible industry stakeholder organisations

Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)

Ledipasvir/sofosbuvir product-specific bioequivalence guidance

Human medicines European public assessment report (EPAR): Piasky, crovalimab, Date of authorisation: 22/08/2024, Revision: 3, Status: Authorised

Validation checklist for Type II quality variations

Human medicines European public assessment report (EPAR): Datroway, datopotamab deruxtecan, Date of authorisation: 04/04/2025, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Lytenava, bevacizumab, Date of authorisation: 27/05/2024, Revision: 3, Status: Authorised

Agenda of the PRAC meeting 9-12 February 2026

Arixtra