This is a summary of the European public assessment report (EPAR) for Brintellix. 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 Brintellix.
For practical information about using Brintellix, patients should read the package leaflet or contact their doctor or pharmacist.
Brintellix : EPAR - Summary for the public (PDF/120.91 KB)
First published: 14/01/2014
Last updated: 14/01/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Depressive Disorder, Major
|Anatomical therapeutic chemical (ATC) code||
H. Lundbeck A/S
|Date of issue of marketing authorisation valid throughout the European Union||
08/09/2021 Brintellix - EMEA/H/C/002717 - IB/0031
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.
Treatment of major depressive episodes in adults.