Human medicines European public assessment report (EPAR): Jesduvroq, daprodustat, Status: Withdrawn application
Human medicines European public assessment report (EPAR): Jesduvroq, daprodustat, Status: Withdrawn application
Human medicines European public assessment report (EPAR): Jesduvroq, daprodustat, Status: Withdrawn application
Questions and Answers about the raw data proof-of-concept pilot for industry
EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?, European Medicines Agency, Amsterdam, the Netherlands, 29 February 2024
CTIS newsflash - 8 December 2023
Guidance on paediatric submissions
Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA’s regulatory activities
Eleventh industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, 4 December 2023
Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised
Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Date of authorisation: 30/05/2017, Revision: 7, Status: Authorised
Data Analysis and Real World Interrogation Network (DARWIN EU)