Is Cobicistat + Elvitegravir + 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 Cobicistat + Elvitegravir + Emtricitabine + Tenofovir, including GENVOYA Film-coated Tablet (200,150,150,10 mg,mg,mg,mg, Film-coated tablet, SAR 3657.20).

Is Cobicistat + Elvitegravir + Emtricitabine + Tenofovir approved by the US FDA?

Drugs@FDA lists 2 application product lines for Cobicistat + Elvitegravir + Emtricitabine + Tenofovir, including STRIBILD (Prescription); GENVOYA (Prescription).

Is Cobicistat + Elvitegravir + Emtricitabine + Tenofovir authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Cobicistat + Elvitegravir + Emtricitabine + Tenofovir: Stribild, Genvoya.

Active substances

Cobicistat + Elvitegravir + Emtricitabine + Tenofovir

SFDA 1
US FDA 2
EMA 2
Health Canada 2
US price lines 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GENVOYA Film-coated Tablet	200,150,150,10 mg,mg,mg,mg	Film-coated tablet · Oral use	30 Bottle	SAR 3657.20	NCE · Prescription	GILEAD SCIENCES LIMITED (CORK)	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
STRIBILD	150MG;150MG;200MG;300MG	tablet · oral	GILEAD SCIENCES INC	Prescription	27 Aug 2012
GENVOYA	150MG;150MG;200MG;EQ 10MG BASE	tablet · oral	GILEAD SCIENCES INC	Prescription	5 Nov 2015

EMA European Union — centrally authorised medicines

Stribild Gilead Sciences Ireland UC · Authorised · authorised 24 May 2013 · ATC J05AR09

Therapeutic indication (EMA)

Treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.

Genvoya Gilead Sciences Ireland UC · Authorised · authorised 19 Nov 2015 · ATC J05AR

Therapeutic indication (EMA)

Genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GENVOYA	02449498	200 MG; 150 MG; 10 MG; 150 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC
STRIBILD	02397137	300 MG; 150 MG; 200 MG; 150 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GENVOYA TABLET	$143.3532	per EA	23 Sep 2026
US NADAC	STRIBILD TABLET	$150.14316	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.

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.