Treatment of premenstrual dysphoric disorder

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Current effective version

Adopted guideline

Reference numberCHMP/607022/2009
Published05/08/2011
Effective from01/02/2012
KeywordsPremenstrual dysphoric disorder (PMDD)
DescriptionThis document provides guidance on the evaluation of medicinal products in the treatment of premenstrual dysphoric disorder. It addresses the identification of the target population including special populations (adolescents), study duration as well as efficacy and safety endpoints.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/02/2012–present


Published: 05/08/2011


Published: 24/05/2010


Published: 19/02/2009


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