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
This EPAR was last updated on 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 |
22
|
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
29/10/2020 Valdoxan - EMEA/H/C/000915 - WS/1849
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
Pharmacotherapeutic group
Psychoanaleptics
Therapeutic indication
Therapeutic indication
Treatment of major depressive episodes in adults.