Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Date of authorisation: 22/11/2018, Revision: 10, Status: Authorised
Human medicines European public assessment report (EPAR): Vevzuo, denosumab, Date of authorisation: 25/06/2025, Revision: 3, Status: Authorised
Transfer of marketing authorisation: questions and answers
Submitting results of paediatric studies
Risk management plans (RMP) in post-authorisation phase: questions and answers
Data quality framework for medicines regulation
Periodic safety update reports (PSURs)
Data Quality Framework for EU medicines regulation: application to Real-World Data
Outcome of the public consultation on the Data Quality Framework for EU Medicines Regulation: application to Real-World Data
Post-authorisation measures: questions and answers