Basic Information
Arava
Regulatory Information
EMEA/H/C/000235
September 2, 1999
May 20, 1999
42
September 4, 2024
Company Information
Germany
D-65926 Frankfurt am Main
Sanofi-Aventis Deutschland Gmbh
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Arava. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arava.