Basic Information
AUBAGIO FILM-COATED TABLETS 14mg
TABLET, FILM COATED
Regulatory Information
SIN14841P
August 31, 2015
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
Company Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Active Ingredients
Strength: 14.0mg
Detailed Information
Contraindications
**Contraindications** Hypersensitivity to the active substance or to any of the excipients. Patients with severe hepatic impairment (Child-Pugh class C). Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l (see section _Fertility, pregnancy and lactation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Pregnancy must be excluded before start of treatment (see section _Fertility, pregnancy and lactation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Breast-feeding women (see section _Fertility, pregnancy and lactation_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with severe immunodeficiency states, e.g. AIDS. Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia. Patients with severe active infection until resolution (see section _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group. Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Indication Information
**Therapeutic indications** AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS). (please refer to section _Pharmacodynamic properties_ for important information on the population for which efficacy has been established – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.)