Is Sofosbuvir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Sofosbuvir, including Grateziano (400 mg, Film-coated tablet, SAR 2024.35); SOFOCURE 400 mg film-coated tablet (400 mg, Film-coated tablet, SAR 5600.00); SOVIRA 400 mg film-coated tablet (400 mg, Film-coated tablet, SAR 5600.00).

Is Sofosbuvir approved by the US FDA?

Drugs@FDA lists 3 application product lines for Sofosbuvir, including SOVALDI (Prescription); SOVALDI (Prescription); SOFOSBUVIR (Discontinued).

Is Sofosbuvir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sofosbuvir: Sovaldi.

Is Sofosbuvir 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.

Are there safety signals or safety updates for Sofosbuvir?

EMA PRAC: 10 entries; US FDA: 7 entries (latest 2024-12-23).

Active substance

Sofosbuvir

SFDA 4
US FDA 3
EMA 1
Health Canada 1
WHO EML 1
Safety 17

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Grateziano	400 mg	Film-coated tablet · Oral use	28 Bottle	SAR 2024.35	Generic · Prescription	Pharco International pharmaceutical company	Valid
SOFOCURE 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	28 Tablet Container	SAR 5600.00	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
SOVIRA 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	28 Tablet Container	SAR 5600.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
SOVALDI 400 mg film-coated tablet	400 mg	Film-coated tablet · Oral use	28 Tablet Container	SAR 62058.80	NCE · Prescription	Gilead Sciences Ireland UC	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HEPATITIS C

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

Product	Strength	Form · route	Applicant	Status	First approved
SOVALDI	400MG; 200MG	tablet · oral	GILEAD SCIENCES INC	Prescription	6 Dec 2013
SOVALDI	150MG/PACKET; 200MG/PACKET	pellets · oral	GILEAD SCIENCES INC	Prescription	28 Aug 2019
SOFOSBUVIR	400MG	tablet · oral	TEVA PHARMS USA INC	Discontinued	27 Jan 2022

EMA European Union — centrally authorised medicines

Sovaldi Gilead Sciences Ireland UC · Authorised · authorised 16 Jan 2014 · ATC J05AX15

Therapeutic indication (EMA)

Sovaldi is indicated in combination with other medicinal products 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. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults 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)

Brand	DIN	Strength	Form · route	Company
SOVALDI	02418355	400 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC

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; 400 mg | Oral > Solid > granules: 200 mg in sachet (EMLc)

Safety signals and safety-related labeling changes

US FDA 23 Dec 2024 SOVALDI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Dec 2024 SOVALDI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 19 Dec 2024 HARVONI — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Dec 2024 HARVONI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Apr 2022 EPCLUSA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Apr 2022 EPCLUSA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 15 Nov 2019 VOSEVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 3 Oct 2019 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 16 May 2019 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 4 Oct 2018 PRAC signal: Dysglycaemia
Action for MAH: update of the product information: Yes
EMA PRAC 17 May 2018 PRAC signal: Dysglycaemia
Action for MAH: update of the product information: No
EMA PRAC 2 Sep 2016 PRAC signal: Drug interaction between direct-acting antivirals (DAAV) and vitamin K antagonists leading to a reduced international normalized ratio (INR)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jun 2016 PRAC signal: Drug interaction with fluindione leading to a reduced international normalized ratio (INR)
Action for MAH: update of the product information: No
EMA PRAC 14 Apr 2016 PRAC signal: Unexpected early hepatocellular carcinoma recurrence
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2016 PRAC signal: Hepatitis B reactivation
Action for MAH: update of the product information: No

All safety entries for sofosbuvir →

Combinations containing Sofosbuvir

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.