Author: ratiopharm GmbH


Long information

What is it?

Leflunomide ratiopharm is a medicine that contains the active substance leflunomide. It is available as white round tablets (10 and 20mg).

Leflunomide ratiopharm is a ?generic medicine?. This means that Leflunomide ratiopharm is similar to a ?reference medicine? already authorised in the European Union (EU) called Arava. For more information on generic medicines, see the question-and-answer document here.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Leflunomide ratiopharmis used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints).

The medicine can only be obtained with a prescription.

How is it used?

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

Leflunomide ratiopharm 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. 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 it work?

The active substance in Leflunomide ratiopharm, 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 it been studied?

The applicant presented data on experimental models from the scientific literature.

Because Leflunomide ratiopharmis 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 benefits has it shown during the studies?

Because Leflunomide ratiopharmis 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.

What is the risk associated?

Because Leflunomide ratiopharmis 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 it been approved?

The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharmhas 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 ratiopharmbe given marketing authorisation

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