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Status: Withdrawn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The marketing authorisation for Repso has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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