MedPath
HSA Product

VOSEVI FILM-COATED TABLETS 400MG/100MG/100MG

Product approved by Health Sciences Authority (SG)

Basic Information

VOSEVI FILM-COATED TABLETS 400MG/100MG/100MG

TABLET, FILM COATED

Regulatory Information

SIN15705P

May 31, 2019

Prescription Only

Therapeutic

ORAL

August 10, 2023

June 3, 2025

XJ05AP56

Company Information

GILEAD SCIENCES SINGAPORE PTE. LTD.

GILEAD SCIENCES SINGAPORE PTE. LTD.

Active Ingredients

Velpatasvir

Strength: 100 mg

Sofosbuvir

Strength: 400 mg

Voxilaprevir

Strength: 100 mg

Detailed Information

Contraindications

**4.3 Contraindications** Hypersensitivity to the active substances or to 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_. Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John’s wort) (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

Indication Information

**4.1 Therapeutic indications** Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

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