Treatment of premenstrual dysphoric disorder - Scientific guideline

HumanScientific guidelines

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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)

Adopted Reference Number: EMA/CHMP/607022/2009 Legal effective date:

English (EN) (371.38 KB - PDF)

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Document history - First version (current)

Guideline on the treatment of premenstrual dysphoric disorder (PMDD)

Adopted Reference Number: EMA/CHMP/607022/2009 Legal effective date:

English (EN) (371.38 KB - PDF)

Poprvé zveřejněno: Poslední aktualizace:
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Overview of comments received on 'guideline on the treatment of premenstrual dysphoric disorder (PMDD)'

Reference Number: EMA/71893/2011

English (EN) (187.52 KB - PDF)

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/EWP/607022/2009

English (EN) (485.48 KB - PDF)

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

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

English (EN) (61.35 KB - PDF)

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