Is Sofosbuvir + Velpatasvir 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, including EPCLUSA 400 mg/100 mg Film-coated Tablet (400,100 mg,mg, Film-coated tablet, SAR 40067.95).

Is Sofosbuvir + Velpatasvir approved by the US FDA?

Drugs@FDA lists 2 application product lines for Sofosbuvir + Velpatasvir, including EPCLUSA (Prescription); EPCLUSA (Prescription).

Is Sofosbuvir + Velpatasvir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sofosbuvir + Velpatasvir: Epclusa.

Is Sofosbuvir + Velpatasvir on the WHO Model List of Essential Medicines?

Yes — 6.4.4.2.1. Medicines for hepatitis C > Pangenotypic direct-acting antiviral combinations (core list): Chronic hepatitis C.

Active substances

Sofosbuvir + Velpatasvir

SFDA 1
US FDA 2
EMA 1
Health Canada 1
US price lines 2
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EPCLUSA 400 mg/100 mg Film-coated Tablet	400,100 mg,mg	Film-coated tablet · Oral use	28 Bottle	SAR 40067.95	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
EPCLUSA	400MG;100MG; 200MG;50MG	tablet · oral	GILEAD SCIENCES INC	Prescription	28 Jun 2016
EPCLUSA	150MG/PACKET;37.5MG/PACKET; 200MG/PACKET;50MG/PACKET	pellets · oral	GILEAD SCIENCES INC	Prescription	10 Jun 2021

EMA European Union — centrally authorised medicines

Epclusa Gilead Sciences Ireland UC · Authorised · authorised 6 Jul 2016 · ATC J05A

Therapeutic indication (EMA)

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EPCLUSA	02456370	400 MG; 100 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	EPCLUSA 400 MG-100 MG TABLET	$865.89214	per EA	23 Sep 2026
US NADAC	SOFOSBUVIR-VELPATASVIR 400-100	$278.02579	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

6.4.4.2.1. Medicines for hepatitis C > Pangenotypic direct-acting antiviral combinations · core
Chronic hepatitis C
Oral > Solid > tablet: 200 mg + 50 mg (EMLc); 400 mg + 100 mg | Oral > Solid > granules: 150 mg + 37.5 mg in sachet (EMLc); 200 mg + 50 mg in sachet (EMLc)

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.