Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Date of authorisation: 27/07/2010, Revision: 26, Status: Authorised

Overview

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. Expand section Collapse section 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. Leflunomide medac : EPAR - Summary for the public English (EN) (79.19 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View Other languages (22) български (BG) (131.97 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View español (ES) (103.64 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View čeština (CS) (104.71 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View dansk (DA) (80.44 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View Deutsch (DE) (83.14 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View eesti (ET) (81.28 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View ελληνικά (EL) (133.55 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View français (FR) (82.97 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View hrvatski (HR) (100.55 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View italiano (IT) (81.6 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View latviešu (LV) (101.19 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View lietuvių (LT) (103.57 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View magyar (HU) (102.44 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View Malti (MT) (106.92 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View Nederlands (NL) (82.07 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View polski (PL) (106.66 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View português (PT) (82.08 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View română (RO) (126.31 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View slovenčina (SK) (105.24 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View slovenščina (SL) (98.18 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View suomi (FI) (80.43 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View svenska (SV) (82.12 KB - PDF) First published: 05/08/2010 Last updated: 12/08/2014 View

Product information

Leflunomide medac : EPAR - Product Information English (EN) (468.12 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View Other languages (24) български (BG) (583.46 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View español (ES) (449.52 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View čeština (CS) (517.41 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View dansk (DA) (527.91 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View Deutsch (DE) (438.93 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View eesti (ET) (412.35 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View ελληνικά (EL) (600.84 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View français (FR) (459.9 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View hrvatski (HR) (525 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View italiano (IT) (431.85 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View latviešu (LV) (541.79 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View lietuvių (LT) (527.54 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View magyar (HU) (543.85 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View Malti (MT) (593.87 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View Nederlands (NL) (422.37 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View polski (PL) (552.13 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View português (PT) (434.47 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View română (RO) (567.15 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View slovenčina (SK) (516.46 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View slovenščina (SL) (519 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View suomi (FI) (421.92 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View svenska (SV) (411.02 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View Íslenska (IS) (411.45 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View norsk (NO) (407.99 KB - PDF) First published: 05/08/2010 Last updated: 04/08/2026 View Latest procedure affecting product information: VR/0000361880 31/07/2026 This medicine's product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Leflunomide medac : EPAR - All Authorised presentations English (EN) (25.06 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View Other languages (24) български (BG) (53.44 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View español (ES) (27.81 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View čeština (CS) (34.78 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View dansk (DA) (27.72 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View Deutsch (DE) (26.32 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View eesti (ET) (27.17 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View ελληνικά (EL) (50.03 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View français (FR) (27.67 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View hrvatski (HR) (38.56 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View italiano (IT) (28.05 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View latviešu (LV) (45.75 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View lietuvių (LT) (44.48 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View magyar (HU) (33.22 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View Malti (MT) (40.62 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View Nederlands (NL) (26.75 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View polski (PL) (35.5 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View português (PT) (27.4 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View română (RO) (44.33 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View slovenčina (SK) (42.91 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View slovenščina (SL) (42.02 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View suomi (FI) (27.75 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View svenska (SV) (27.74 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View Íslenska (IS) (27.34 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View norsk (NO) (28.68 KB - PDF) First published: 05/08/2010 Last updated: 02/08/2017 View Leflunomide medac : EPAR - Conditions imposed on member states for safe and effective use - Annex IV English (EN) (19.14 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View Other languages (21) български (BG) (105.97 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View español (ES) (18.71 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View čeština (CS) (93.76 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View dansk (DA) (19.81 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View Deutsch (DE) (23.57 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View eesti (ET) (23.22 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View ελληνικά (EL) (89.13 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View français (FR) (23.43 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View italiano (IT) (18.89 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View latviešu (LV) (90.74 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View lietuvių (LT) (88.7 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View magyar (HU) (63.43 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View Malti (MT) (92.84 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View Nederlands (NL) (19.3 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View polski (PL) (91.97 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View português (PT) (23.41 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View română (RO) (88.54 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View slovenčina (SK) (90.25 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View slovenščina (SL) (88.21 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View suomi (FI) (18.58 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View svenska (SV) (22.56 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View

Product details

Name of medicine Leflunomide medac Active substance leflunomide International non-proprietary name (INN) or common name leflunomide Therapeutic area (MeSH) Arthritis, Rheumatoid Anatomical therapeutic chemical (ATC) code L04AK01 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.

Authorisation details

EMA product number EMEA/H/C/001227 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 and hybrid medicines . Marketing authorisation holder medac Gesellschaft für klinische Spezialpräparate mbH Theaterstrasse 6 22880 Wedel Germany Marketing authorisation issued 27/07/2010 Revision 26

Assessment history

Expand section Collapse section Changes since initial authorisation of medicine Leflunomide medac : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (153.03 KB - PDF) First published: 04/07/2025 Last updated: 04/08/2026 View Leflunomide medac : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (141.02 KB - PDF) First published: 26/09/2011 Last updated: 04/07/2025 View Leflunomide medac-H-C-PSUSA-00001837-202309 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/352161/2024 English (EN) (91.27 KB - PDF) First published: 30/07/2024 View Leflunomide medac-H-C-1227-X-0012-G : EPAR - Assessment Report - Extension Adopted Reference Number: EMA/CHMP/478482/2013 English (EN) (243.72 KB - PDF) First published: 08/10/2013 Last updated: 08/10/2013 View Initial marketing authorisation documents Leflunomide medac : EPAR - Public assessment report English (EN) (324.42 KB - PDF) First published: 05/08/2010 Last updated: 05/08/2010 View CHMP summary of positive opinion for Leflunomide medac Adopted Reference Number: EMA/CHMP/291554/2010 English (EN) (77.29 KB - PDF) First published: 21/05/2010 Last updated: 21/05/2010 View

Topics

Generic and hybrid medicines Medicines