This is a summary of the European public assessment report (EPAR) for Leflunomide medac. 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 Leflunomide medac.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
L04AK01
ATC Item
leflunomide
Pharmacotherapeutic Group
Selective immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| leflunomide | N/A | 来氟米特 |
EMA Name
Leflunomide medac
Medicine Name
Leflunomide medac
Aliases
N/ANo risk management plan link.
