Is Raltegravir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Raltegravir, including ISENTRESS 600MG F.C.TABLET (600 mg, Film-coated tablet, SAR 1679.95); Raltavir (400 mg, Film-coated tablet, SAR 1567.80).

Is Raltegravir approved by the US FDA?

Drugs@FDA lists 6 application product lines for Raltegravir, including ISENTRESS (Prescription); ISENTRESS HD (Prescription); ISENTRESS (Prescription); ISENTRESS (Prescription); RALTEGRAVIR POTASSIUM (Prescription).

Is Raltegravir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Raltegravir: Isentress.

Is Raltegravir on the WHO Model List of Essential Medicines?

Yes — 6.4.2.4. Antiretrovirals > Integrase inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Raltegravir?

EMA PRAC: 2 entries; US FDA: 3 entries (latest 2021-05-18).

Active substance

Raltegravir

SFDA 2
US FDA 6
EMA 2
Health Canada 2
US price lines 2
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ISENTRESS 600MG F.C.TABLET	600 mg	Film-coated tablet · Oral use	60 Bottle	SAR 1679.95	NCE · Prescription	MERCK SHARP & DOHME LIMITED	Valid
Raltavir	400 mg	Film-coated tablet · Oral use	60 Bottle	SAR 1567.80	Generic · Prescription	Saudi Amarox	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
ISENTRESS	EQ 400MG BASE	tablet · oral	MSD SUB MERCK	Prescription	12 Oct 2007
ISENTRESS HD	EQ 600MG BASE	tablet · oral	MSD SUB MERCK	Prescription	12 Oct 2007
ISENTRESS	EQ 25MG BASE; EQ 100MG BASE	tablet, chewable · oral	MSD SUB MERCK	Prescription	21 Dec 2011
ISENTRESS	EQ 100MG BASE/PACKET	powder · oral	MSD SUB MERCK	Prescription	20 Dec 2013
RALTEGRAVIR POTASSIUM	EQ 400MG BASE	tablet · oral	HETERO LABS LTD III	Prescription	19 Dec 2024
RALTEGRAVIR POTASSIUM	EQ 600MG BASE	tablet · oral	LUPIN	Prescription	6 May 2025

EMA European Union — centrally authorised medicines

Isentress Merck Sharp & Dohme B.V. · Authorised · authorised 19 Dec 2007 · ATC J05AJ01

Therapeutic indication (EMA)

Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.

Raltegravir Viatris Viatris Limited · Application withdrawn · ATC J05AJ01

Therapeutic indication (EMA)

Treatment of human immunodeficiency virus (HIV-1)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ISENTRESS	02301881	400 MG	TABLET · ORAL	MERCK CANADA INC
ISENTRESS HD	02465337	600 MG	TABLET · ORAL	MERCK CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ISENTRESS 400 MG TABLET	$34.53888	per EA	23 Sep 2026
US NADAC	ISENTRESS HD 600 MG TABLET	$34.51502	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)

6.4.2.4. Antiretrovirals > Integrase inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Liquid: 100 mg granules for oral suspension | Oral > Solid: 400 mg tablet (EML); 25 mg tablet (chewable)

Safety signals and safety-related labeling changes

US FDA 18 May 2021 ISENTRESS — 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
US FDA 18 May 2021 ISENTRESS — 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
US FDA 18 May 2021 ISENTRESS — 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
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No

All safety entries for raltegravir →

Combinations containing Raltegravir

Lamivudine + raltegravir

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.