Is Doravirine 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, including Pifeltro (100 mg, Film-coated tablet, SAR 1361.80).

Is Doravirine approved by the US FDA?

Drugs@FDA lists 1 application product line for Doravirine, including PIFELTRO (Prescription).

Is Doravirine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Doravirine: Pifeltro.

Are there safety signals or safety updates for Doravirine?

US FDA: 2 entries (latest 2026-09-29).

Active substance

Doravirine

SFDA 1
US FDA 1
EMA 1
Health Canada 1
US price lines 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Pifeltro	100 mg	Film-coated tablet · Oral use	30 Bottle	SAR 1361.80	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
PIFELTRO	100MG	tablet · oral	MSD MERCK CO	Prescription	30 Aug 2018

EMA European Union — centrally authorised medicines

Pifeltro Merck Sharp & Dohme B.V. · Authorised · authorised 22 Nov 2018 · ATC J05AG06

Therapeutic indication (EMA)

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PIFELTRO	02481545	100 MG	TABLET · ORAL	MERCK CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PIFELTRO 100 MG TABLET	$60.78687	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.

Safety signals and safety-related labeling changes

US FDA 29 Sep 2026 DELSTRIGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Sep 2026 PIFELTRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for doravirine →

Combinations containing Doravirine

Doravirine + lamivudine + tenofovir

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.