Please be advised the HTML version of SPC documents is currently unavailable. We are working to resolve the issue.
Visitors to the site are advised to refer exclusively to the PDF version of the SPC.
If this causes any inconvenience please contact
info@hpra.ie or vetinfo@hpra.ie

 

Aubagio

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

Status

Authorised/WithdrawnAuthorised
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

Documents

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

Educational Materials - HCP

Educational Materials - Patient

« Back