Regulatory PathRegulatory requirements compared

Active substances

Cobicistat + Darunavir + Emtricitabine + Tenofovir

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SYMTUZA150MG;800MG;200MG;EQ 10MG BASEtablet · oralJANSSEN PRODSPrescription17 Jul 2018

EMA European Union — centrally authorised medicines

Symtuza Janssen-Cilag International · Authorised · authorised 21 Sep 2017 · ATC J05AR22

Therapeutic indication (EMA)

Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of Symtuza.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SYMTUZA0247372010 MG; 150 MG; 800 MG; 200 MGTABLET · ORALJANSSEN INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSYMTUZA 800-150-200-10 MG TAB$152.86728per EA23 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.