Aubagio (teriflunomide)
- Region
- 🇪🇺 EU
- Active substance
- teriflunomide
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- CHMP opinion
- Thu 21 Mar 2013
- EU approval
- Mon 26 Aug 2013
- Application
- EMEA/H/C/002514
- ATC
- L04AK02
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Teriflunomide Viatris (previously Teriflunomide Mylan) Authorised · Viatris Limited
- 🇪🇺 Teriflunomide Accord Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.