The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


14 milligram(s) Film-coated tablet

sanofi-aventis groupeEU/1/13/838/001-005

Main Information

Trade NameAubagio
Active SubstancesTeriflunomide
Strength14 milligram(s)
Dosage FormFilm-coated tablet
Licence Holdersanofi-aventis groupe
Licence NumberEU/1/13/838/001-005

Group Information

ATC CodeL04AA Selective immunosuppressants
L04AA31 teriflunomide


Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal products on restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

« Back