Is Elbasvir + Grazoprevir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Elbasvir + Grazoprevir.

Is Elbasvir + Grazoprevir approved by the US FDA?

Drugs@FDA lists 1 application product line for Elbasvir + Grazoprevir, including ZEPATIER (Discontinued).

Is Elbasvir + Grazoprevir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Elbasvir + Grazoprevir: Zepatier.

Active substances

Elbasvir + Grazoprevir

SFDA 1
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ZEPATIER 100/50 mg film-coated tablet	100,50 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 49171.25	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ZEPATIER	50MG;100MG	tablet · oral	MSD SUB MERCK	Discontinued	28 Jan 2016

EMA European Union — centrally authorised medicines

Zepatier Merck Sharp & Dohme B.V. · Authorised · authorised 22 Jul 2016 · ATC J05AP54

Therapeutic indication (EMA)

ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.

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.