Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/206815/2013
Published26/03/2015
Effective from01/09/2015
KeywordsPaediatric, drug evaluation, drug approval guideline, hypertension, clinical evaluation, efficacy criteria, safety aspects
DescriptionThis document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of hypertension. It highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2015–present


Published: 26/03/2015


Published: 30/09/2013


Published: 18/12/2008


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