Clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/341363/2014
Published16/07/2014
Effective from26/12/2014
KeywordsStroke, systemic embolism, atrial fibrillation, anticoagulant
DescriptionThis document provides guidance on the coduct of trials to develop medicinal products in prevention of stroke and systemic embolic events in patients with non-valvular artial fibrillation.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Second draft guideline


Draft guideline


Concept paper

In operation: 26/12/2014–present


Published: 11/11/2014


Published: 15/11/2013


Published: 15/08/2012


Published: 07/04/2011


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