Repso

leflunomide

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The marketing authorisation for Repso has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Repso : EPAR - Summary for the public BG = bălgarski 2011-03-28  
Repso : EPAR - Summary for the public ES = español 2011-03-28  
Repso : EPAR - Summary for the public CS = čeština 2011-03-28  
Repso : EPAR - Summary for the public DA = dansk 2011-03-28  
Repso : EPAR - Summary for the public DE = Deutsch 2011-03-28  
Repso : EPAR - Summary for the public ET = eesti keel 2011-03-28  
Repso : EPAR - Summary for the public EL = elliniká 2011-03-28  
Repso : EPAR - Summary for the public EN = English 2011-03-28  
Repso : EPAR - Summary for the public FR = français 2011-03-28  
Repso : EPAR - Summary for the public IT = italiano 2011-03-28  
Repso : EPAR - Summary for the public LV = latviešu valoda 2011-03-28  
Repso : EPAR - Summary for the public LT = lietuvių kalba 2011-03-28  
Repso : EPAR - Summary for the public HU = magyar 2011-03-28  
Repso : EPAR - Summary for the public MT = Malti 2011-03-28  
Repso : EPAR - Summary for the public NL = Nederlands 2011-03-28  
Repso : EPAR - Summary for the public PL = polski 2011-03-28  
Repso : EPAR - Summary for the public PT = português 2011-03-28  
Repso : EPAR - Summary for the public RO = română 2011-03-28  
Repso : EPAR - Summary for the public SK = slovenčina 2011-03-28  
Repso : EPAR - Summary for the public SL = slovenščina 2011-03-28  
Repso : EPAR - Summary for the public FI = suomi 2011-03-28  
Repso : EPAR - Summary for the public SV = svenska 2011-03-28  

This EPAR was last updated on 21/04/2016 .

Authorisation details

Product details

Product details for Repso
NameRepso
Agency product numberEMEA/H/C/001222
Active substance

leflunomide

International non-proprietary name (INN) or common name

leflunomide

Therapeutic area Arthritis, RheumatoidArthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code L04AA13
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Repso
Marketing-authorisation holder

Teva B.V.

Revision11
Date of issue of marketing authorisation valid throughout the European Union14/03/2011

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

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

Name Language First published Last updated
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21
Repso : EPAR - Product Information SV = svenska 2011-03-28 2016-04-21

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.


Name Language First published Last updated
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  
Repso : EPAR - All Authorised presentations SV = svenska 2011-03-28  

Name Language First published Last updated
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  
Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2011-03-28  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Repso : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2011-09-20 2016-04-21

Initial marketing-authorisation documents

Name Language First published Last updated
Repso : EPAR - Public assessment report SV = svenska 2011-03-28  
CHMP summary of positive opinion for Repso SV = svenska 2010-12-17  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Repso