Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: AUBAGIO   
Auth. number : EU/1/13/838
Active substance : Teriflunomide
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA31 - Teriflunomide
(See WHO ATC Index)
Indication: AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS).
(please refer to section 5.1 for important information on the population for which efficacy has been established).
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/08/2013 Centralised - Authorisation EMEA/H/C/2514 (2013)5611 of 26/08/2013
26/09/2013 Corrigendum (2013)5611 of 26/08/2013
13/12/2013 Centralised - Notification EMEA/H/C/2514/N/1
Updated with Decision(2014)8893 of 19/11/2014
19/12/2013 Centralised - Variation EMEA/H/C/2514/IA/2
Updated with Decision(2014)8893 of 19/11/2014
24/07/2014 Centralised - Variation EMEA/H/C/2514/II/4
Updated with Decision(2014)8893 of 19/11/2014
21/11/2014 PSUSA - Modification EMEA/H/C/2514/II/3, EMEA/H/C/2514/PSUV/5 (2014)8893 of 19/11/2014
23/06/2015 PSUSA - Modification EMEA/H/C/2514/PSUSA/10135 (2015)4315 of 19/06/2015
18/12/2015 PSUSA - Modification EMEA/H/C/2514/PSUSA/10135/201503 (2015)9640 of 16/12/2015