Active ingredients: Leflunomide
Arava 10 mg film-coated tablets.
White to almost white, round film-coated tablet, imprinted with ZBN on one side.
Each tablet contains 10 mg of leflunomide.
Excipients with known effect: Each tablet contains 78 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties. A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
Silica colloidal anhydrous
Magnesium stearate (E470b)
Titanium dioxide (E171)
Blister: Aluminium/Aluminium blister. Pack sizes: 30 and 100 film-coated tablets.
Bottle: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany
Date of first authorisation: 02 September 1999
Date of latest renewal: 02 September 2009