Leflunomide medac (leflunomide)
- Region
- 🇪🇺 EU
- Active substance
- leflunomide
- Company
- medac Gesellschaft für klinische Spezialpräparate mbH
- Status
- Authorised
- Therapeutic area
- Arthritis, Rheumatoid
- EU approval
- Tue 27 Jul 2010
- Designations
- Generic
- Application
- EMEA/H/C/001227
- ATC
- L04AK01
- Official record
- www.ema.europa.eu
Indication
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Leflunomide Zentiva (previously Leflunomide Winthrop) Authorised · Zentiva k.s.
- 🇪🇺 Arava Authorised · Sanofi-aventis Deutschland GmbH
- 🇪🇺 Leflunomide ratiopharm Authorised · Ratiopharm GmbH
- 🇪🇺 Repso Withdrawn · Teva B.V.
- 🇪🇺 Leflunomide Teva Lapsed · Teva Pharma B.V.
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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.