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

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Current effective version

Adopted 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

Adopted guideline

 

Overview of comments

 

Draft guideline


Concept paper

Published: 18/11/2016

 

Published: 18/11/2016

 

Published: 10/06/2015


Published: 16/01/2013


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