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Repso

Active Substance: leflunomide
Common Name: leflunomide
ATC Code: L04AA13
Marketing Authorisation Holder: Teva B.V.
Active Substance: leflunomide
Status: Withdrawn
Authorisation Date: 2011-03-14
Therapeutic Area: Arthritis, Rheumatoid Arthritis, Psoriatic
Pharmacotherapeutic Group: Immunosuppressants

Therapeutic 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.

The marketing authorisation for Repso has been withdrawn at the request of the marketing authorisation holder.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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