Repso

RSS

leflunomide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Repso has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 21/04/2016

Authorisation details

Product details
Name
Repso
Agency product number
EMEA/H/C/001222
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
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
14/03/2011
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

30/03/2016 Repso - EMEA/H/C/001222 - IA/0020

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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