Clinical investigation of medicinal products in the treatment of lipid disorders

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Current effective version

Revision 3 - Adopted guideline

Reference numberEMA/CHMP/748108/2013 Rev. 3
Published08/07/2016
Effective from01/01/2017
KeywordsLipid lowering agents, cholesterol, hypercholesterolemia, statins
DescriptionThis document provides guidance on the evaluation of drugs in the treatment of lipid disorders. It details the main regulatory requirements that are expected to be followed in the development of a lipid modifying medicinal product.


Document history

Revision 3

Current version

Adopted guideline

Published: 08/07/2016

Revision 1 and 2

Adopted guideline

 

Overview of comments

 

Draft guideline (Rev. 1 and 2)

 

Draft guideline (Rev. 1)

 

Concept paper (Rev. 2)

 

Concept paper (Rev. 1)

In operation: 01/06/2014–31/12/2016

 

Published: 16/01/2014

 

Published: 14/12/2012

 

Published: 21/12/2010

 

Published: 23/07/2009

 

Published: 30/05/2008

First version

Adopted guideline

 

Concept paper 

In operation: 01/01/2005–31/05/2014

 

Published: 21/05/2001


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