Is Bictegravir + Emtricitabine + Tenofovir 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 Bictegravir + Emtricitabine + Tenofovir, including BIKTARVY (200,52.45,25 mg,mg,mg, Film-coated tablet, SAR 2881.95).

Is Bictegravir + Emtricitabine + Tenofovir approved by the US FDA?

Drugs@FDA lists 1 application product line for Bictegravir + Emtricitabine + Tenofovir, including BIKTARVY (Prescription).

Active substances

Bictegravir + Emtricitabine + Tenofovir

SFDA 1
US FDA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BIKTARVY	200,52.45,25 mg,mg,mg	Film-coated tablet · Oral use	30 Bottle	SAR 2881.95	NCE · Prescription	Gilead Sciences Ireland UC	Valid

Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS

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

Product	Strength	Form · route	Applicant	Status	First approved
BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE; EQ 30MG BASE;120MG;EQ 15MG BASE	tablet · oral	GILEAD SCIENCES INC	Prescription	7 Feb 2018

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BIKTARVY	02478579	50 MG; 25 MG; 200 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC

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.