Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
AUBAGIO 7 mg film-coated tablets.
AUBAGIO 14 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). AUBAGIO 7 mg film-coated tablets: Very light greenish-bluish grey to pale greenish-blue, hexagonal film-coated 7.5 mm tablet with imprint on one side (‘7’) and engraved with the corporate logo on other side. AUBAGIO 14 mg film-coated tablets: Pale blue to pastel blue, pentagonal film-coated 7.5 mm tablet with imprint on one side (‘14’) and engraved with a corporate logo on the other side. |
Each film-coated tablet contains 7 mg of teriflunomide.
Excipient with known effect: Each tablet contains 77 mg of lactose (as monohydrate).
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), which functionally connects with the respiratory chain. As a consequence of the inhibition, teriflunomide generally reduces the proliferation of rapidly dividing cells that depend on 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 Tablet coating: 7 mg film-coated tablets: Hypromellose 14 mg film-coated tablets: Hypromellose |
AUBAGIO 7 mg film-coated tablets:
Polyamide/aluminium/poly(vinyl chloride)-aluminium blisters inserted in a wallet (28 film-coated tablets) and packed in a carton containing 28 film-coated tablets.
AUBAGIO 14 mg film-coated tablets:
Polyamide/aluminium/poly(vinyl chloride)-aluminium blisters inserted in wallets (14 and 28 filmcoated tablets) and packed in cartons containing 14, 28, 84 (3 wallets of 28), and 98 (7 wallets of 14) film-coated tablets.
Polyamide/aluminium/poly(vinyl chloride)-aluminium perforated unit-dose blisters in cartons containing 10x1 film-coated tablets.
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
AUBAGIO 7 mg film-coated tablets:
EU/1/13/838/006 28 tablets
AUBAGIO 14 mg film-coated tablets:
EU/1/13/838/001 14 tablets
EU/1/13/838/002 28 tablets
EU/1/13/838/003 84 tablets
EU/1/13/838/004 98 tablets
EU/1/13/838/005 10x1 tablet
Date of first authorisation: 26 August 2013
Date of latest renewal: 28 May 2018
| Drug | Countries | |
|---|---|---|
| AUBAGIO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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