Clinical development of fixed combination medicinal products

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Current effective version

Revision 2 - Adopted guideline

Reference numberEMA/CHMP/158268/2017


Effective from01/10/2017 
KeywordsFixed combination medicinal products, guidance, clinical development
DescriptionRevision 2 replaces 'Guideline on clinical development of fixed combination medicinal products' (CHMP/EWP/240/95 Rev. 1). This guideline covers fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be authorised substances or substances that have not yet been authorised in the EU.

Document history

Revision 2

Current version

Adopted guideline


Draft guideline

Concept paper

In operation from: 01/10/2017-present 

Published: 13/05/2015

Published: 01/03/2013

Revision 1



Adopted guideline

Overview of comments

Draft guideline

Published: 01/09/2009

Published: 19/02/2009

Published: 19/02/2009

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