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.
Arava : EPAR - Summary for the public (PDF/76.34 KB)
First published: 20/07/2009
Last updated: 29/06/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Sanofi-aventis Deutschland GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
09/04/2018 Arava - EMEA/H/C/000235 - N/0073
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.