Reagila

RSS

cariprazine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Reagila. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Reagila.

For practical information about using Reagila, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 25/06/2018

Authorisation details

Product details
Name
Reagila
Agency product number
EMEA/H/C/002770
Active substance
cariprazine hydrochloride
International non-proprietary name (INN) or common name
cariprazine
Therapeutic area (MeSH)
Schizophrenia
Anatomical therapeutic chemical (ATC) code
N05AX15
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gedeon Richter
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
13/07/2017
Contact address
Gyomroi ut 19-21
1103 Budapest
Hungary

Product information

07/05/2018 Reagila - EMEA/H/C/002770 - N/0006

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Reagila is indicated for the treatment of schizophrenia in adult patients.

Assessment history

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