Leflunomide medac

leflunomide

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This is a summary of the European public assessment report (EPAR) for Leflunomide medac. 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 medac.

What is Leflunomide medac?

Leflunomide medac is a medicine that contains the active substance leflunomide. It is available as tablets (10, 15 and 20 mg).

Leflunomide medac is a ‘generic medicine’. This means that Leflunomide medac is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Arava.

What is Leflunomide medac used for?

Leflunomide medac is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).

The medicine can only be obtained with a prescription.

How is Leflunomide medac used?

Leflunomide medac treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient’s liver, white blood cell counts and platelet counts before prescribing Leflunomide medac, and regularly during treatment.

Leflunomide medac treatment usually starts with a ‘loading dose’ of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up to six months.

How does Leflunomide medac work?

The active substance in Leflunomide medac, leflunomide, is an immunosuppressant. It reduces inflammation by reducing the production of immune cells called ‘lymphocytes’, which are responsible for inflammation. Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase’, which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.

How has Leflunomide medac been studied?

Because Leflunomide medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefit and risk of Leflunomide medac?

Because Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine’s.

Why has Leflunomide medac been approved?

The CHMP concluded that, in accordance with EU requirements, Leflunomide medac has been shown to have comparable quality and to be bioequivalent to Arava. Therefore, the CHMP’s view was that, as for Arava, the benefit outweighs the identified risk. The Committee recommended that Leflunomide medac be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Leflunomide medac ?

A risk management plan has been developed to ensure that Leflunomide medac is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Leflunomide medac, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Leflunomide medac

The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide medac on 27 July 2010.

Name Language First published Last updated
Leflunomide medac : EPAR - Summary for the public BG = bălgarski 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public ES = español 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public CS = čeština 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public DA = dansk 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public DE = Deutsch 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public ET = eesti keel 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public EL = elliniká 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public EN = English 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public FR = français 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public IT = italiano 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public LV = latviešu valoda 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public LT = lietuvių kalba 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public HU = magyar 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public MT = Malti 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public NL = Nederlands 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public PL = polski 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public PT = português 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public RO = română 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public SK = slovenčina 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public SL = slovenščina 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public FI = suomi 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public SV = svenska 2010-08-05 2014-08-12
Leflunomide medac : EPAR - Summary for the public HR = Hrvatski 2010-08-05 2014-08-12

This EPAR was last updated on 29/02/2016 .

Authorisation details

Product details

Product details for Leflunomide medac
NameLeflunomide medac
Agency product numberEMEA/H/C/001227
Active substance

leflunomide

International non-proprietary name (INN) or common name

leflunomide

Therapeutic area Arthritis, Rheumatoid
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 Leflunomide medac
Marketing-authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH

Revision12
Date of issue of marketing authorisation valid throughout the European Union27/07/2010

Contact address:

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstrasse 6
22880 Wedel
Germany

Product information

Product information

10/12/2015  Leflunomide medac -EMEA/H/C/001227 -IAIN/0025

Name Language First published Last updated
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29
Leflunomide medac : EPAR - Product Information HR = Hrvatski 2010-08-05 2016-02-29

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
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08
Leflunomide medac : EPAR - All Authorised presentations HR = Hrvatski 2010-08-05 2013-10-08

Name Language First published Last updated
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  
Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-08-05  

Pharmacotherapeutic group

Selective immunosuppressants

Therapeutic indication

Leflunomide is indicated for the treatment of adult patients with:

  • active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD).

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

Initial marketing-authorisation documents

Name Language First published Last updated
Leflunomide medac : EPAR - Public assessment report HR = Hrvatski 2010-08-05  
CHMP summary of positive opinion for Leflunomide medac HR = Hrvatski 2010-05-21  

Authorised

This medicine is approved for use in the European Union

More information on Leflunomide medac