Clinical investigation of medicinal products for the treatment of acute heart failure

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/EWP/2986/03 Rev.1
Effective from01/12/2015
KeywordsAcute heart failure, acute decompensated heart failure, acute heart failure syndromes, chronic heart failure, dyspnoea, B-type natriuretic peptide (BNP)
DescriptionThis document provides guidance on the main regulatory requirements for the development of a medicinal product for the treatment of acute heart failure in adults. It focueses mainly on pharmacological intervention of left ventricular dysfunction with or without concomitant right ventricular dysfunction.

Document history

Revision 1 

Current version

Adopted guideline

Draft guideline

Concept paper

In operation: 01/12/2015–present

Published: 15/10/2012

Published: 04/06/2010

First versionAdopted guidelineIn operation: 01/01/2005–30/11/2015

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