ARAVA Film-coated tablet Ref.[8128] Active ingredients: Leflunomide

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany

Product name and form

Arava 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to almost white, round film-coated tablet, imprinted with ZBN on one side.

Qualitative and quantitative composition

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.

Active Ingredient Description
Leflunomide

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.
List of Excipients

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

Pack sizes and marketing

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.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany

Marketing authorization dates and numbers

EU/1/99/118/001-004

Date of first authorisation: 02 September 1999
Date of latest renewal: 02 September 2009

Drugs

Drug Countries
ARAVA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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