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.
Reagila : EPAR - Summary for the public (PDF/76.51 KB)
First published: 18/09/2017
Last updated: 18/09/2017
Reagila : EPAR - Risk management plan summary (PDF/185.96 KB) (updated)
First published: 22/03/2022
Last updated: 26/04/2022
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|Date of issue of marketing authorisation valid throughout the European Union||
Gyomroi ut 19-21
04/04/2022 Reagila - EMEA/H/C/002770 - R/0026
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.
Reagila is indicated for the treatment of schizophrenia in adult patients.