Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application
Guidance for competent authorities on how to highlight VNRAs
Agenda of the CHMP meeting 16-19 September 2024
Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Date of authorisation: 23/02/2004, Revision: 31, Status: Authorised
Human medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Date of authorisation: 25/06/1996, Revision: 34, Status: Authorised
IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
Early dialogue with healthcare professional organisations for marketing authorisation applications: 1-year report
Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0513/2023
New fee regulation: webinar for human industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 October 2024, 10:30 (CEST) to 24 October 2024, 11:30 (CEST)