Treatment of premenstrual dysphoric disorder

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Current effective version

Adopted guideline

Reference numberCHMP/607022/2009
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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