Human medicines European public assessment report (EPAR): Entecavir Viatris (previously Entecavir Mylan), entecavir, Date of authorisation: 18/09/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Elahere, mirvetuximab soravtansine, Date of authorisation: 14/11/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Osenvelt, denosumab, Date of authorisation: 14/02/2025, Revision: 6, Status: Authorised

Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024

Data Analysis and Real World Interrogation Network (DARWIN EU)

ICH guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline

ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver: Questions and Answers - Step 5

ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5

Summary of opinion: Pepaxti, 17/09/2026 Positive

Programme of the 2026 annual meeting of the European network of paediatric research at EMA (EnprEMA)