Assessment of cardiovascular safety profile of medicinal products

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Current version

Reflection paper

Reference numberEMA/CHMP/50549/2015
Published29/03/2016
KeywordsCardiovascular safety, cardiovascular outcome study (CVOT), major cardiovascular event (MACE), cardiovascular and metabolic disease, diabetes, obesity, hypertension, hypercholesterolaemia
DescriptionThis document provides recommendations for the evaluation of the cardiovascular safety profile of new, non-generic medicinal products that are intended for long-term treatment of cardiovascular and metabolic diseases.


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First version

Current version

Reflection paper


Overview of comments


Draft reflection paper

Published: 29/03/2016


Published: 29/03/2016


Published: 12/06/2015


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