EMEA-001303-PIP01-12-M01

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Overview

Product details for -
Invented name-
Active substance

Bumetanide

Decision numberP/0016/2017
PIP numberEMEA-001303-PIP01-12-M01
Pharmaceutical form(s)Age-appropriate oral liquid formulation; Prolonged-release tablet
Condition(s)/indication(s)

Treatment of autistic spectrum disorder

Route(s) of administrationOral use
PIP applicant

Neurochlore
France
Tel. +33 680117494
E-mail: denis.ravel@initial-rd.fr

Decision typeRPM: decision refers to a refusal on the application for modifiction of an agreed PIP

Decision