Treatment of premenstrual dysphoric disorder - Scientific guideline

This 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.

Keywords: Premenstrual dysphoric disorder (PMDD)

Current effective version

Guideline on the treatment of premenstrual dysphoric disorder (PMDD)

AdoptedLegal effective date: 01/02/2012Reference Number: EMA/CHMP/607022/2009

Document history - First version (current)

Guideline on the treatment of premenstrual dysphoric disorder (PMDD)

AdoptedLegal effective date: 01/02/2012Reference Number: EMA/CHMP/607022/2009

Overview of comments received on 'guideline on the treatment of premenstrual dysphoric disorder (PMDD)'

Reference Number: EMA/71893/2011

Draft guideline on the treatment of Premenstrual Dysphoric Disorder (PMDD)

Consultation dates: 20/05/2010 to 30/11/2010Draft: consultation closedReference Number: EMA/CHMP/EWP/607022/2009

Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder (PMDD)

Reference Number: EMEA/CHMP/EWP/11877/2009