Thymanax

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 Thymanax. 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 Thymanax.

For practical information about using Thymanax, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 04/10/2017

Authorisation details

Product details
Name
Thymanax
Agency product number
EMEA/H/C/000916
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
Servier (Ireland) Industries Ltd
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
19/02/2009
Contact address
Gorey Road
Arklow, Co. Wicklow
Ireland

Product information

11/09/2017 Thymanax - EMEA/H/C/000916 - IA/0036

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

Changes since initial authorisation of medicine

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