Clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation - Scientific guideline
Table of contents
This document provides guidance on the conduct of trials to develop medicinal products in prevention of stroke and systemic embolic events in patients with non-valvular artial fibrillation.
Keywords: Stroke, systemic embolism, atrial fibrillation, anticoagulant
-
List item
Overview of comments received on 'Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation' (PDF/141.38 KB)
First published: 11/11/2014
Last updated: 11/11/2014
EMA/CHMP/341511/2014 -
List item
Second draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation (PDF/502.73 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/01/2014
EMA/CHMP/623942/2013 -
List item
Draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation (PDF/171.47 KB)
Draft: consultation closed
First published: 15/08/2012
Last updated: 15/08/2012
Consultation dates: 15/08/2012 to 15/02/2013
EMA/CHMP/450916/2012 -
List item
Concept paper on the need for a guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with atrial fibrillation (PDF/119.03 KB)
Draft: consultation closed
First published: 07/04/2011
Last updated: 07/04/2011
Consultation dates: 17/02/2011 to 31/05/2011
EMA/CHMP/68875/2011