Leflunomide ratiopharm (leflunomide)
- Region
- 🇪🇺 EU
- Active substance
- leflunomide
- Company
- Ratiopharm GmbH
- Status
- Authorised
- Therapeutic area
- Arthritis, Rheumatoid
- CHMP opinion
- Thu 23 Sep 2010
- EU approval
- Sun 28 Nov 2010
- Designations
- Generic
- Application
- EMEA/H/C/002035
- 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.
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