Arava (leflunomide)
- Region
- 🇪🇺 EU
- Active substance
- leflunomide
- Company
- Sanofi-aventis Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Arthritis, Rheumatoid; Arthritis, Psoriatic
- CHMP opinion
- Thu 20 May 1999
- EU approval
- Thu 02 Sep 1999
- Application
- EMEA/H/C/000235
- 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); active psoriatic arthritis. 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.
- 🇪🇺 Leflunomide medac Authorised · medac Gesellschaft für klinische Spezialpräparate mbH
- 🇪🇺 Leflunomide ratiopharm Authorised · Ratiopharm GmbH
- 🇪🇺 Repso Withdrawn · Teva B.V.
- 🇪🇺 Leflunomide Teva Lapsed · Teva Pharma B.V.
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