Active ingredients: Leflunomide
Arava 10 mg film-coated tablets.
Film-coated tablet.
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.
Tablet core:
Maize starch
Povidone (E1201)
Crospovidone (E1202)
Silica colloidal anhydrous
Magnesium stearate (E470b)
Lactose monohydrate
Film-coating:
Talc (E553b)
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 8000
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
EU/1/99/118/001-004
Date of first authorisation: 02 September 1999
Date of latest renewal: 02 September 2009