European Union example instances - E2B(R3) testing files

Human medicines European public assessment report (EPAR): Lacosamide Adroiq, lacosamide, Date of authorisation: 31/05/2023, Revision: 7, Status: Authorised

EU reference instances (EDQM revision)

Human medicines European public assessment report (EPAR): Lyumjev (previously Liumjev), insulin lispro, Date of authorisation: 24/03/2020, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Date of authorisation: 01/08/2001, Revision: 31, Status: Authorised

Human medicines European public assessment report (EPAR): Humalog, insulin lispro, Date of authorisation: 30/04/1996, Revision: 36, Status: Authorised

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 70, Status: Authorised

Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Date of authorisation: 09/09/2014, Revision: 13, Status: Authorised

Consolidated 3-year rolling work plan for the Methodology Working Party 2026-2028

Consolidated 3-year rolling work plan for the Non-clinical domain 2026-2028