Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive
Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive
Orphan designation: rezatapopt Treatment of ovarian cancer, 09/12/2025 Positive
Human medicines European public assessment report (EPAR): Atazanavir Krka, atazanavir, Date of authorisation: 25/03/2019, Revision: 3, Status: Withdrawn
EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Date of authorisation: 22/11/2018, Revision: 10, Status: Authorised
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