Aubagio
teriflunomide
Table of contents
Overview
Aubagio is a medicine that contains the active substance teriflunomide. It is used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
-
List item
Aubagio : EPAR - Summary for the public (PDF/135.57 KB)
First published: 06/09/2013
Last updated: 23/06/2021
EMA/317454/2021 -
-
List item
Aubagio : EPAR - Risk management plan (PDF/3.01 MB)
First published: 10/11/2022
Last updated: 22/08/2023
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 Winthrop Industrie
|
Revision |
26
|
Date of issue of marketing authorisation valid throughout the European Union |
26/08/2013
|
Contact address |
82 Avenue Raspail |
Product information
13/07/2023 Aubagio - EMEA/H/C/002514 - N/0044
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
Therapeutic indication
AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).