Is Sofosbuvir + Velpatasvir + Voxilaprevir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Sofosbuvir + Velpatasvir + Voxilaprevir, including VOSEVI 400MG/100MG/100MG F.C.TABLET (400,100,100 mg,mg,mg, Film-coated tablet, SAR 35531.35).

Is Sofosbuvir + Velpatasvir + Voxilaprevir approved by the US FDA?

Drugs@FDA lists 1 application product line for Sofosbuvir + Velpatasvir + Voxilaprevir, including VOSEVI (Prescription).

Active substances

Sofosbuvir + Velpatasvir + Voxilaprevir

SFDA 1
US FDA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VOSEVI 400MG/100MG/100MG F.C.TABLET	400,100,100 mg,mg,mg	Film-coated tablet · Oral use	28 Bottle	SAR 35531.35	NCE · Prescription	Gilead Sciences Ireland UC	Valid

Indications — CHI Daman Drug Formulary

HEPATITIS C

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VOSEVI	400MG;100MG;100MG	tablet · oral	GILEAD SCIENCES INC	Prescription	18 Jul 2017

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VOSEVI	02467542	400 MG; 100 MG; 100 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.