Is Etravirine 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 Etravirine, including INTELENCE 100 MG TABLETS (100 mg, Tablet, SAR 1575.20).

Is Etravirine approved by the US FDA?

Drugs@FDA lists 5 application product lines for Etravirine, including INTELENCE (Prescription); ETRAVIRINE (Prescription); ETRAVIRINE (Prescription); ETRAVIRINE (Prescription); ETRAVIRINE (Discontinued).

Is Etravirine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Etravirine: Intelence.

Are there safety signals or safety updates for Etravirine?

EMA PRAC: 2 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2019-07-10).

Active substance

Etravirine

SFDA 1
US FDA 5
EMA 1
Health Canada 2
US price lines 3
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INTELENCE 100 MG TABLETS	100 mg	Tablet · Oral use	120 Tablet Container	SAR 1575.20	NCE · Prescription	JANSSEN-CILAG	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
INTELENCE	100MG; 200MG; 25MG	tablet · oral	JANSSEN R AND D	Prescription	18 Jan 2008
ETRAVIRINE	100MG; 200MG	tablet · oral	AMNEAL	Prescription	14 Jun 2021
ETRAVIRINE	100MG; 200MG	tablet · oral	PHARMOBEDIENT	Prescription	13 Apr 2022
ETRAVIRINE	100MG; 200MG	tablet · oral	BIONPHARMA	Prescription	2 Oct 2025
ETRAVIRINE	25MG	tablet · oral	AMNEAL	Discontinued	14 Jun 2021

EMA European Union — centrally authorised medicines

Intelence Janssen-Cilag International NV · Authorised · authorised 28 Aug 2008 · ATC J05AG04

Therapeutic indication (EMA)

Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age. This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INTELENCE	02306778	100 MG	TABLET · ORAL	JANSSEN INC
INTELENCE	02375931	200 MG	TABLET · ORAL	JANSSEN INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ETRAVIRINE 100 MG TABLET	$7.76708	per EA	18 Mar 2026
US NADAC	ETRAVIRINE 200 MG TABLET	$9.94336	per EA	23 Sep 2026
US NADAC	INTELENCE 200 MG TABLET	$24.30324	per EA	17 Jun 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 10 Jul 2019 INTELENCE — 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
MHRA 11 Dec 2014 Etravirine: reports of severe hypersensitivity reactions
Cases of severe hypersensitivity syndromes, sometimes fatal, have been reported with etravirine.

All safety entries for etravirine →

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.