US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| VOCABRIA | EQ 30MG BASE | tablet · oral | VIIV HLTHCARE | Prescription | 21 Jan 2021 |
| APRETUDE | 600MG/3ML (200MG/ML) | suspension, extended release · intramuscular | VIIV HLTHCARE | Prescription | 20 Dec 2021 |
EMA European Union — centrally authorised medicines
Apretude ViiV Healthcare B.V. · Authorised · authorised 15 Sep 2023 · ATC J05AJ04
Therapeutic indication (EMA)
Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| APRETUDE | 02547465 | 30 MG | TABLET · ORAL | VIIV HEALTHCARE ULC |
| APRETUDE | 02547473 | 200 MG / ML | SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR | VIIV HEALTHCARE ULC |
| VOCABRIA | 02497204 | 30 MG | TABLET · ORAL | VIIV HEALTHCARE ULC |
Safety signals and safety-related labeling changes
- US FDA 11 Apr 2025 APRETUDE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Apr 2025 VOCABRIA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Apr 2025 CABENUVA KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for cabotegravir →
Combinations containing Cabotegravir
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.