Is Glecaprevir + Pibrentasvir 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 Glecaprevir + Pibrentasvir, including MAVIRET 100 mg/40 mg Film Coated Tablet (100,40 mg,mg, Film-coated tablet, SAR 39417.35).

Is Glecaprevir + Pibrentasvir approved by the US FDA?

Drugs@FDA lists 2 application product lines for Glecaprevir + Pibrentasvir, including MAVYRET (Prescription); MAVYRET (Prescription).

Is Glecaprevir + Pibrentasvir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Glecaprevir + Pibrentasvir: Maviret.

Is Glecaprevir + Pibrentasvir 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

Glecaprevir + Pibrentasvir

SFDA 1
US FDA 2
EMA 1
Health Canada 2
US price lines 1
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
MAVIRET 100 mg/40 mg Film Coated Tablet	100,40 mg,mg	Film-coated tablet · Oral use	84 Blister	SAR 39417.35	NCE · Prescription	ABBVIE Inc.	Valid

Indications — CHI Daman Drug Formulary

HEPATITIS C

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

Product	Strength	Form · route	Applicant	Status	First approved
MAVYRET	100MG;40MG	tablet · oral	ABBVIE	Prescription	3 Aug 2017
MAVYRET	50MG/PACKET;20MG/PACKET	pellets · oral	ABBVIE	Prescription	10 Jun 2021

EMA European Union — centrally authorised medicines

Maviret AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 26 Jul 2017 · ATC J05AP57

Therapeutic indication (EMA)

Maviret coated granules is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in children 3 years and older. Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MAVIRET	02467550	100 MG; 40 MG	TABLET · ORAL	ABBVIE CORPORATION
MAVIRET	02522470	50 MG / SACHET; 20 MG / SACHET	GRANULES · ORAL	ABBVIE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MAVYRET 100-40 MG TABLET	$152.98338	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: 50 mg + 20 mg granules (EMLc) | Oral > Solid > tablet: 100 mg + 40 mg

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.