Arava

RSS

leflunomide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 07/05/2018

Authorisation details

Product details
Name
Arava
Agency product number
EMEA/H/C/000235
Active substance
leflunomide
International non-proprietary name (INN) or common name
leflunomide
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code
L04AA13
Publication details
Marketing-authorisation holder
Sanofi-aventis Deutschland GmbH
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
02/09/1999
Contact address
D-65926 Frankfurt am Main
Germany

Product information

09/04/2018 Arava - EMEA/H/C/000235 - N/0073

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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