Is Remdesivir 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 Remdesivir, including Veklury (100 mg, Powder for concentrate for solution for infusion, SAR 1769.65).

Is Remdesivir approved by the US FDA?

Drugs@FDA lists 2 application product lines for Remdesivir, including VEKLURY (Prescription); VEKLURY (Discontinued).

Is Remdesivir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Remdesivir: Veklury.

Are there safety signals or safety updates for Remdesivir?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2024-12-19).

Active substance

Remdesivir

SFDA 1
US FDA 2
EMA 1
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Veklury	100 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1769.65	NCE · Prescription	Gilead Sciences Ireland UC	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
VEKLURY	100MG/VIAL	powder · intravenous	GILEAD SCIENCES INC	Prescription	22 Oct 2020
VEKLURY	100MG/20ML (5MG/ML)	solution · intravenous	GILEAD SCIENCES INC	Discontinued	22 Oct 2020

EMA European Union — centrally authorised medicines

Veklury Gilead Sciences Ireland UC · Authorised · authorised 3 Jul 2020 · ATC J05AB16

Therapeutic indication (EMA)

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg): with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 5.1)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VEKLURY	02502143	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	GILEAD SCIENCES CANADA INC

Safety signals and safety-related labeling changes

US FDA 19 Dec 2024 VEKLURY — 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 11 Feb 2021 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2021 PRAC signal: Sinus bradycardia
Action for MAH: update of the product information: No
EMA PRAC 1 Oct 2020 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: No

All safety entries for remdesivir →

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.