EMEA-002051-PIP02-16

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Overview

Product details for -
Invented name-
Active substance

Allopregnanolone

Decision numberP/0357/2017
PIP numberEMEA-002051-PIP02-16
Pharmaceutical form(s)Intravenous use
Condition(s)/indication(s)

Treatment of postpartum depression

Route(s) of administrationSolution for infusion
PIP applicant

Sage Therapeutics Inc
Tel. +1 6172998380
E-mail: contact@sagerx.com

Decision typeP: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision