Is Doravirine + Lamivudine + Tenofovir 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 Doravirine + Lamivudine + Tenofovir, including Delstrigo (100,300,245 mg,mg,mg, Film-coated tablet, SAR 2413.85).

Is Doravirine + Lamivudine + Tenofovir approved by the US FDA?

Drugs@FDA lists 1 application product line for Doravirine + Lamivudine + Tenofovir, including DELSTRIGO (Prescription).

Is Doravirine + Lamivudine + Tenofovir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Doravirine + Lamivudine + Tenofovir: Delstrigo.

Active substances

Doravirine + Lamivudine + Tenofovir

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
Delstrigo	100,300,245 mg,mg,mg	Film-coated tablet · Oral use	30 Tablet Container	SAR 2413.85	NCE · Prescription	Merck Sharp & Dohme B.V	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
DELSTRIGO	100MG;300MG;300MG	tablet · oral	MSD MERCK CO	Prescription	30 Aug 2018

EMA European Union — centrally authorised medicines

Delstrigo Merck Sharp & Dohme B.V. · Authorised · authorised 22 Nov 2018 · ATC J05AR

Therapeutic indication (EMA)

Delstrigo is indicated for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir. Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DELSTRIGO	02482592	300 MG; 300 MG; 100 MG	TABLET · ORAL	MERCK CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DELSTRIGO 100-300-300 MG TAB	$93.06069	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.