Valdoxan

RSS

Agomelatine

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

Overview

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.

This EPAR was last updated on 08/08/2022

Authorisation details

Product details
Name
Valdoxan
Agency product number
EMEA/H/C/000915
Active substance
Agomelatine
International non-proprietary name (INN) or common name
Agomelatine
Therapeutic area (MeSH)
Depressive Disorder, Major
Anatomical therapeutic chemical (ATC) code
N06AX22
Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
19/02/2009
Contact address
50, rue Carnot
F-92284 Suresnes Cedex
France

Product information

09/11/2021 Valdoxan - EMEA/H/C/000915 - N/0050

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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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