Human medicines European public assessment report (EPAR): Steglatro, ertugliflozin, Date of authorisation: 21/03/2018, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Romvimza, vimseltinib, Date of authorisation: 17/09/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Lumark, lutetium (177Lu) chloride, Date of authorisation: 18/06/2015, Revision: 9, Status: Withdrawn

Extended EudraVigilance medicinal product dictionary (XEVMPD) training

Norditropin FlexPro / Norditropin NordiFlex

ICH M15 guideline on general principles for model-informed drug development - Scientific guideline

ICH M15 Guideline on general principles for model-informed drug development - Step 5

Aliskiren product-specific bioequivalence guidance

PhV non-compliance notification contact points at National Competent Authority (NCA) level

Agenda of the CVMP meeting 10-12 February 2026