Aubagio

RSS

teriflunomide

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

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).

This EPAR was last updated on 25/11/2022

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
24
Date of issue of marketing authorisation valid throughout the European Union
26/08/2013
Contact address

82 Avenue Raspail
94250 Gentilly
France

Product information

21/11/2022 Aubagio - EMEA/H/C/002514 - T/0040

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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

Selective immunosuppressants

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).

Assessment history

Changes since initial authorisation of medicine

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