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

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/494506/2012
Published02/10/2012
Effective from20/03/2013
KeywordsLipid disorders, paediatric, familial hypercholesterolemia
DescriptionThis document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders. It highlights differences from adult patients with lipid disorders and points out specific paediatric issues.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 20/03/2013–present


Published: 06/11/2012


Published: 08/07/2010


Published: 22/01/2009


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