Basic Information
MAYZENT FILM-COATED TABLET 2MG
TABLET, FILM COATED
Regulatory Information
SIN16039P
November 16, 2020
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
Company Information
NOVARTIS (SINGAPORE) PTE LTD
NOVARTIS (SINGAPORE) PTE LTD
Active Ingredients
Strength: 2mg
Detailed Information
Contraindications
**4.3 Contraindications** - Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Immunodeficiency syndrome. - History of progressive multifocal leukoencephalopathy or cryptococcal meningitis. - Active malignancies. - Severe liver impairment (Child-Pugh class C). - Patients who in the previous 6 months had a myocardial infarction (MI), unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients homozygous for CYP2C9\*3 (CYP2C9\*3\*3) genotype (poor metaboliser). - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**4.1 Therapeutic indications** Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).