Is Cobicistat + Darunavir approved by the US FDA?

Drugs@FDA lists 2 application product lines for Cobicistat + Darunavir, including PREZCOBIX (Prescription); PREZCOBIX PED (Prescription).

Is Cobicistat + Darunavir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cobicistat + Darunavir: Rezolsta.

Active substances

Cobicistat + Darunavir

US FDA 2
EMA 1
Health Canada 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
PREZCOBIX	150MG;EQ 800MG BASE; 150MG;EQ 675MG BASE	tablet · oral	JANSSEN PRODS	Prescription	29 Jan 2015
PREZCOBIX PED	90MG;EQ 600MG BASE	tablet, for suspension · oral	JANSSEN PRODS	Prescription	27 Feb 2026

EMA European Union — centrally authorised medicines

Rezolsta · Authorised · authorised 19 Nov 2014 · ATC J05AR14

Therapeutic indication (EMA)

Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 25 kg). Genotypic testing should guide the use of Rezolsta.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PREZCOBIX	02426501	150 MG; 800 MG	TABLET · ORAL	JANSSEN 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.