Teriflunomide Accord (teriflunomide)
Generic
- Region
- 🇪🇺 EU
- Active substance
- teriflunomide
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Wed 09 Nov 2022
- Designations
- Generic
- Application
- EMEA/H/C/005960
- ATC
- L04AK02
- Official record
- www.ema.europa.eu
Indication
Teriflunomide Accord 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
- 🇪🇺 Aubagio Authorised · Sanofi Winthrop Industrie
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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.