Valdoxan
Agomelatine
Table of contents
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.
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List item
Valdoxan : EPAR - Summary for the public (PDF/79.77 KB)
First published: 17/03/2009
Last updated: 19/01/2017
EMA/659629/2012 -
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List item
Valdoxan : EPAR - Risk-management-plan summary (PDF/209.49 KB)
First published: 14/01/2021
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
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.