Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/707532/2013
Published18/11/2016
Effective from01/07/2017
KeywordsPaediatric, drug evaluation, drug approval guideline, heart failure, acute heart failure, clinical evaluation, efficacy criteria, safety aspects
DescriptionThis document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of acute heart failure. It highlights differences from adult patients with acute heart failure and points out paediatric-specific aspects.


Document history

First version

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline


PDF iconConcept paper

Published: 18/11/2016

Published: 18/11/2016

Published: 10/06/2015


Published: 16/01/2013


Related content


How useful was this page?

Add your rating