AUBAGIO Film-coated tablets Ref.[7968] Active ingredients: Teriflunomide

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Sanofi-aventis groupe, 54, rue La Boรฉtie, F-75008, Paris, France

Product name and form

AUBAGIO 14 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (“14”) and engraved with a corporate logo on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 14 mg of teriflunomide.

Excipient with known effect: each tablet contains 72 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Teriflunomide

Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that selectively and reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase (DHO-DH), required for the de novo pyrimidine synthesis. As a consequence teriflunomide reduces the proliferation of dividing cells that need de novo synthesis of pyrimidine to expand. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes.

List of Excipients

Tablet core:

Lactose monohydrate
Maize starch
Microcrystalline cellulose
Sodium starch glycolate (Type A)
Hydroxypropylcellulose
Magnesium stearate

Tablet coating:

Hypromellose
Titanium dioxide (E171)
Talc
Macrogol 8000
Indigo carmine aluminum lake (E132)

Pack sizes and marketing

Polyamide/aluminium/poly(vinyl chloride) - aluminium blisters inserted in wallets (14 and 28 film-coated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.

Each wallet is placed in a protective sleeve.

Polyamide/aluminium/poly(vinyl chloride) - aluminium perforated unit-dose blister packs in cartons containing 10x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-aventis groupe, 54, rue La Boรฉtie, F-75008, Paris, France

Marketing authorization dates and numbers

EU/1/13/838/001
EU/1/13/838/002
EU/1/13/838/003
EU/1/13/838/004
EU/1/13/838/005

Date of first authorisation: 26 August 2013

Date of latest renewal: 28 May 2018

Drugs

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

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