Regulatory PathRegulatory requirements compared

Active substances

Cabotegravir + Rilpivirine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CABENUVA KIT400MG/2ML (200MG/ML);600MG/2ML (300MG/ML); 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)suspension, extended release · intramuscularVIIV HLTHCAREPrescription21 Jan 2021

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CABENUVA02497220300 MG / ML; 200 MG / MLKIT; SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULARVIIV HEALTHCARE ULC
CABENUVA02497247300 MG / ML; 200 MG / MLSUSPENSION (EXTENDED-RELEASE); KIT · INTRAMUSCULARVIIV HEALTHCARE ULC

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.