Is Abacavir + Dolutegravir + Lamivudine 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 Abacavir + Dolutegravir + Lamivudine, including TRIUMEQ 50mg/600mg/300mg film-coated tablet (50,300,600 mg,mg,mg, Film-coated tablet, SAR 3128.80).

Is Abacavir + Dolutegravir + Lamivudine approved by the US FDA?

Drugs@FDA lists 2 application product lines for Abacavir + Dolutegravir + Lamivudine, including TRIUMEQ (Prescription); TRIUMEQ PD (Prescription).

Is Abacavir + Dolutegravir + Lamivudine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Abacavir + Dolutegravir + Lamivudine: Triumeq.

Is Abacavir + Dolutegravir + Lamivudine on the WHO Model List of Essential Medicines?

Yes — 6.4.2.5. Fixed-dose combinations of antiretrovirals (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Active substances

Abacavir + Dolutegravir + Lamivudine

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TRIUMEQ 50mg/600mg/300mg film-coated tablet	50,300,600 mg,mg,mg	Film-coated tablet · Oral use	30 Bottle	SAR 3128.80	NCE · Prescription	Glaxo Saudi Arabia Ltd.	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
TRIUMEQ	EQ 600MG BASE;EQ 50MG BASE;300MG	tablet · oral	VIIV HLTHCARE	Prescription	22 Aug 2014
TRIUMEQ PD	EQ 60MG BASE;EQ 5MG BASE;30MG	tablet, for suspension · oral	VIIV HLTHCARE	Prescription	30 Mar 2022

EMA European Union — centrally authorised medicines

Triumeq ViiV Healthcare B.V. · Authorised · authorised 31 Aug 2014 · ATC J05AR13

Therapeutic indication (EMA)

Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected children of at least 3 months of age weighing at least 6 kg to less than 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. Triumeq is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infected adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRIUMEQ	02430932	300 MG; 50 MG; 600 MG	TABLET · ORAL	VIIV HEALTHCARE ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRIUMEQ 600-50-300 MG TABLET	$130.00625	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.

WHO WHO Model List of Essential Medicines (2025)

6.4.2.5. Fixed-dose combinations of antiretrovirals · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid > tablet: 60 mg (as sulfate) + 5 mg + 30 mg (dispersible, scored) (EMLc)

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.