Evaluation of medicinal products for the treatment of irritable bowel syndrome

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/457920/2012 Rev. 1
Effective from01/04/2015
KeywordsIrritable bowel syndrome, Rome criteria, patient reported outcome (PRO), health related quality of life (HrQoL)
DescriptionThis document addresses the European Union regulatory position in the main topics of clinical development of new medicinal products in the treatment of irritable bowel syndrome.

Document history

Revision 1 

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/04/2015–present

Published: 25/09/2014

Published: 19/07/2013

Published: 08/06/2012

First versionAdopted guidelineIn operation: 01/09/2003–01/04/2015

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