Aubagio

teriflunomide

Table of contents

Opinion

On 22 April 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Aubagio. The marketing authorisation holder for this medicinal product is sanofi-aventis groupe.

The CHMP adopted a new 7 mg strength (film-coated tablet) and an extension to the existing indication as follows:1

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).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Key facts

Name
Aubagio
Agency product number
EMEA/H/C/002514
International non-proprietary name (INN) or common name
  • teriflunomide
Active substance
  • Teriflunomide
Therapeutic area
Multiple Sclerosis
Date opinion adopted
22/04/2021
Company name
sanofi-aventis groupe 
Status
Positive
Application type
Post-authorisation

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