Treatment of premenstrual dysphoric disorder

Current effective version

PDF iconAdopted 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/02/2012–present


Published: 05/08/2011


Published: 24/05/2010


Published: 19/02/2009


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