This is a summary of the European public assessment report (EPAR) for Valdoxan. 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 Valdoxan.
For practical information about using Valdoxan, patients should read the package leaflet or contact their doctor or pharmacist.
Valdoxan : EPAR - Summary for the public (PDF/79.77 KB)
First published: 17/03/2009
Last updated: 19/01/2017
Valdoxan : EPAR - Risk-management-plan summary (PDF/209.49 KB)
First published: 14/01/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Depressive Disorder, Major
|Anatomical therapeutic chemical (ATC) code||
Les Laboratoires Servier
|Date of issue of marketing authorisation valid throughout the European Union||
50, rue Carnot
F-92284 Suresnes Cedex
29/10/2020 Valdoxan - EMEA/H/C/000915 - WS/1849
- 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.