Aubagio

RSS

teriflunomide

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

Overview

This is a summary of the European public assessment report (EPAR) for Aubagio. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Aubagio.

This EPAR was last updated on 01/06/2018

Authorisation details

Product details
Name
Aubagio
Agency product number
EMEA/H/C/002514
Active substance
Teriflunomide
International non-proprietary name (INN) or common name
teriflunomide
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AA31
Publication details
Marketing-authorisation holder
Sanofi-aventis Groupe  
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
25/08/2013
Contact address
Sanofi-aventis Groupe
174, avenue de France
F-75013 Paris
France

Product information

28/05/2018 Aubagio - EMEA/H/C/002514 - R/0016

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

Selective immunosuppressant

Therapeutic indication

Treatment of adult patients with relapsing-remitting multiple sclerosis (MS).

Assessment history

Changes since initial authorisation of medicine

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