Teriflunomide Viatris (previously Teriflunomide Mylan) (teriflunomide)
Generic
- Region
- 🇪🇺 EU
- Active substance
- teriflunomide
- Company
- Viatris Limited
- 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/005962
- ATC
- L04AK02
- Official record
- www.ema.europa.eu
Indication
Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC 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 Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Aubagio Authorised · Sanofi Winthrop Industrie
Follow Teriflunomide Viatris (previously Teriflunomide Mylan)
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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.