Prognia
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🇪🇺EU · EMAAuthorisedATC: L04AK01

Arava(leflunomide)

Arthritis, Rheumatoid;Arthritis, Psoriatic

Marketing Authorisation Holder: Sanofi-aventis Deutschland GmbH

EMA Authorisation: 02/09/1999

INN: leflunomide

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.