Is 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 Dolutegravir + Lamivudine, including Dovato (300,52.6 ,mg, Film-coated tablet, SAR 2885.15).

Is Dolutegravir + Lamivudine approved by the US FDA?

Drugs@FDA lists 1 application product line for Dolutegravir + Lamivudine, including DOVATO (Prescription).

Is Dolutegravir + Lamivudine authorised in the European Union?

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

Active substances

Dolutegravir + Lamivudine

SFDA 1
US FDA 1
EMA 1
Health Canada 1
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Dovato	300,52.6 ,mg	Film-coated tablet · Oral use	30 Bottle	SAR 2885.15	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
DOVATO	EQ 50MG BASE;300MG	tablet · oral	VIIV HLTHCARE	Prescription	8 Apr 2019

EMA European Union — centrally authorised medicines

Dovato ViiV Healthcare B.V. · Authorised · authorised 1 Jul 2019 · ATC J05AR

Therapeutic indication (EMA)

Dovato is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DOVATO	02491753	50 MG; 300 MG	TABLET · ORAL	VIIV HEALTHCARE ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DOVATO 50-300 MG TABLET	$105.22465	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.

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.