This is a summary of the European public assessment report (EPAR) for Repso. 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 recomm ndations on the conditions of use for Repso.
Repso is a ‘generic medicine’. This means that Repso is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Arava. For more information on generic medicines, see
What is RepsoMedicinalused for?
Repso 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 Repso used?
Repso 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 Repso, and regularly during treatment.
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Repso treatment 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 Repso work?
The active substance in Repso, 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 Repso been studied?
Because Repso is a generic medicine, studies in patients have been limited to te ts 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.
Arava, the benefit outweighs the identified risk. The Committee recommended that Repso be given marketing authorisation.
Repso to TEVA Pharma B.V. on 14 March 2011. The marketing authorisation is valid for five years, after which it can be renewed.
The full EPAR for R pso can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Repso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency’s website.
This summary was last updated in