Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib, Date of authorisation: 26/08/2013, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Date of authorisation: 23/11/2015, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Inrebic, fedratinib, Date of authorisation: 08/02/2021, Revision: 8, Status: Authorised

Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)

Marketing authorisation application (MAA) - pre-submission interactions form

New fee regulation: General questions and answers for all applicants

Human medicines European public assessment report (EPAR): Celsentri, maraviroc, Date of authorisation: 18/09/2007, Revision: 31, Status: Authorised

Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Date of authorisation: 19/11/2019, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 9, Status: Authorised

5th Veterinary Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, from 10 November 2025, 10:00 (CET) to 10 November 2025, 15:00 (CET)