Brintellix

RSS

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 14/08/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
H. Lundbeck A/S
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
17/12/2013
Contact address
Ottiliavej 9
DK-2500 Valby
Denmark

Product information

18/07/2018 Brintellix - EMEA/H/C/002717 - IB/0020

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PSYCHOANALEPTICS

Therapeutic indication

Treatment of major depressive episodes in adults

Assessment history

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