Regulatory PathRegulatory requirements compared

Active substances

Ledipasvir + Sofosbuvir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HARVONI 400/90 mg film-coated tablet400,90 mg,mgFilm-coated tablet · Oral use28 Tablet ContainerSAR 47139.30NCE · PrescriptionGILEAD SCIENCES LIMITEDValid
Indications — CHI Daman Drug Formulary

HEPATITIS C

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

ProductStrengthForm · routeApplicantStatusFirst approved
HARVONI90MG;400MG; 45MG;200MGtablet · oralGILEAD SCIENCES INCPrescription10 Oct 2014
HARVONI33.75MG/PACKET;150MG/PACKET; 45MG/PACKET;200MG/PACKETpellets · oralGILEAD SCIENCES INCPrescription28 Aug 2019

EMA European Union — centrally authorised medicines

Harvoni Gilead Sciences Ireland UC · Authorised · authorised 17 Nov 2014 · ATC J05AX65

Therapeutic indication (EMA)

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HARVONI0243222690 MG; 400 MGTABLET · ORALGILEAD SCIENCES CANADA INC

WHO WHO Model List of Essential Medicines (2025)

  • 6.4.4.2.2. Medicines for hepatitis C > Non-pangenotypic direct-acting antiviral combinations · core
    Chronic hepatitis C
    Oral > Solid: 90 mg + 400 mg tablet

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.