Reagila
cariprazine
Table of contents
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.
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List item
Reagila : EPAR - Summary for the public (PDF/76.51 KB)
First published: 18/09/2017
Last updated: 18/09/2017
EMA/339882/2017 -
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List item
Reagila : EPAR - Risk management plan summary (PDF/185.96 KB)
First published: 22/03/2022
Last updated: 26/04/2022
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Gedeon Richter
|
Revision |
7
|
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
02/06/2022 Reagila - EMEA/H/C/002770 - N/0029
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Psycholeptics
Therapeutic indication
Reagila is indicated for the treatment of schizophrenia in adult patients.