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||
28/06/2019 Brintellix - EMEA/H/C/002717 - PSUSA/00010052/201809
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Treatment of major depressive episodes in adults