Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Sanofi-aventis groupe, 54, rue La Boรฉtie, F-75008, Paris, France
AUBAGIO 14 mg film-coated tablets.
Pharmaceutical Form |
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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. |
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 | |
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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 |
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Tablet core: Lactose monohydrate Tablet coating: Hypromellose |
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.
Sanofi-aventis groupe, 54, rue La Boรฉtie, F-75008, Paris, France
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
Drug | Countries | |
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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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