🇪🇺 Teriflunomide HMR1726 in European Union

EMA authorised Teriflunomide HMR1726 on 26 August 2013

Marketing authorisation

EMA — authorised 26 August 2013

  • Application: EMEA/H/C/002514
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Aubagio
  • 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).
  • Status: approved

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Teriflunomide HMR1726 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Teriflunomide HMR1726 approved in European Union?

Yes. EMA authorised it on 26 August 2013.

Who is the marketing authorisation holder for Teriflunomide HMR1726 in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.