Leflunomide ratiopharm

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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 Leflunomide ratiopharm. 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 ratiopharm.

This EPAR was last updated on 12/04/2018

Authorisation details

Product details
Name
Leflunomide ratiopharm
Agency product number
EMEA/H/C/002035
Active substance
leflunomide
International non-proprietary name (INN) or common name
leflunomide
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA13
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Ratiopharm GmbH
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
29/11/2010
Contact address
Graf-Arco-Str. 3
D-89079 Ulm
Germany

Product information

21/12/2017 Leflunomide ratiopharm - EMEA/H/C/002035 - IAIN/0022

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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