EMEA-000228-PIP01-08-M04

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Overview

Product details for Sycrest
Invented nameSycrest
Active substance

Asenapine (maleate)

Decision numberP/0299/2014
PIP numberEMEA-000228-PIP01-08-M04
Pharmaceutical form(s)Sublingual tablets
Condition(s)/indication(s)

Treatment of bipolar I disorder

Route(s) of administrationOral use
PIP applicant

N.V. Organon
The Netherlands
Tel. +33 180464738
E-mail: pip.information@merck.com

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-000228-PIP01-08-M04
Compliance check opinion date18/08/2017
Compliance check outcomePositive

Decision

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