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.
This EPAR was last updated on 29/02/2016 .
10/12/2015 Leflunomide medac -EMEA/H/C/001227 -IAIN/0025
- 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.
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.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Leflunomide medac : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||26/09/2011||29/02/2016|
|Leflunomide medac-H-C-1227-X-0012-G : EPAR - Assessment Report - Extension||HR = Hrvatski||08/10/2013|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Leflunomide medac : EPAR - Public assessment report||HR = Hrvatski||05/08/2010|
|CHMP summary of positive opinion for Leflunomide medac||HR = Hrvatski||21/05/2010|