Clinical development of fixed combination medicinal products

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Current effective version

Revision 2 - Adopted guideline

Reference numberEMA/CHMP/158268/2017
Published

31/03/2017

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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