Brintellix

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vortioxetine

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

Overview

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.

This EPAR was last updated on 27/09/2021

Authorisation details

Product details
Name
Brintellix
Agency product number
EMEA/H/C/002717
Active substance
Vortioxetine
International non-proprietary name (INN) or common name
vortioxetine
Therapeutic area (MeSH)
Depressive Disorder, Major
Anatomical therapeutic chemical (ATC) code
N06AX26
Publication details
Marketing-authorisation holder
H. Lundbeck A/S
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
18/12/2013
Contact address

Ottiliavej 9
DK-2500 Valby
Denmark

Product information

08/09/2021 Brintellix - EMEA/H/C/002717 - IB/0031

Product information documents contain:

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

Psychoanaleptics

Therapeutic indication

Treatment of major depressive episodes in adults.

Assessment history

Changes since initial authorisation of medicine

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