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Leflunomide Teva

Active Substance: leflunomide
Common Name: leflunomide
ATC Code: L04AA13
Marketing Authorisation Holder: Teva Pharma B.V.
Active Substance: leflunomide
Status: Withdrawn
Authorisation Date: 2011-03-10
Therapeutic Area: Arthritis, Rheumatoid
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).

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 Leflunomide Teva has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

Source: European Medicines Agency

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