Is Efavirenz 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 Efavirenz, including Monovira (600 mg, Film-coated tablet, SAR 1575.20).

Is Efavirenz approved by the US FDA?

Drugs@FDA lists 11 application product lines for Efavirenz, including EFAVIRENZ (Prescription); EFAVIRENZ (Prescription); EFAVIRENZ (Prescription); EFAVIRENZ (Prescription); EFAVIRENZ (Prescription).

Is Efavirenz authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Efavirenz: Efavirenz Teva.

Is Efavirenz on the WHO Model List of Essential Medicines?

Yes — 6.4.2.2. Antiretrovirals > Non-nucleoside reverse transcriptase inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Efavirenz?

EMA PRAC: 7 entries; US FDA: 5 entries (latest 2023-11-08).

Active substance

Efavirenz

SFDA 1
US FDA 11
EMA 3
Health Canada 3
US price lines 1
WHO EML 1
Safety 12

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Monovira	600 mg	Film-coated tablet · Oral use	30 Blister	SAR 1575.20	Generic · Prescription	Saudi Amarox	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
EFAVIRENZ	50MG; 100MG; 200MG	capsule · oral	AUROBINDO PHARMA	Prescription	15 Dec 2017
EFAVIRENZ	600MG	tablet · oral	HETERO LABS LTD III	Prescription	27 Apr 2018
EFAVIRENZ	600MG	tablet · oral	CIPLA	Prescription	15 Jun 2018
EFAVIRENZ	600MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	21 Sep 2018
EFAVIRENZ	600MG	tablet · oral	MACLEODS PHARMS	Prescription	10 May 2024
SUSTIVA	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	BRISTOL MYERS SQUIBB	Discontinued	17 Sep 1998
SUSTIVA	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BRISTOL MYERS SQUIBB	Discontinued	1 Feb 2002
EFAVIRENZ	600MG	tablet · oral	MYLAN	Discontinued	17 Feb 2016
EFAVIRENZ	600MG	tablet · oral	PHARMOBEDIENT	Discontinued	12 Mar 2018
EFAVIRENZ	600MG	tablet · oral	AUROBINDO PHARMA	Discontinued	30 Aug 2018
EFAVIRENZ	600MG	tablet · oral	STRIDES PHARMA	Discontinued	16 Jun 2021

EMA European Union — centrally authorised medicines

Efavirenz Teva Teva B.V. · Authorised · authorised 9 Jan 2012 · ATC J05AG03

Therapeutic indication (EMA)

Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.

Sustiva Bristol-Myers Squibb Pharma EEIG · Withdrawn · authorised 28 May 1999 · ATC J05AG03

Therapeutic indication (EMA)

Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.

Stocrin Merck Sharp & Dohme B.V. · Withdrawn · authorised 28 May 1999 · ATC J05AG03

Therapeutic indication (EMA)

Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-EFAVIRENZ	02418428	600 MG	TABLET · ORAL	AURO PHARMA INC
MYLAN-EFAVIRENZ	02381524	600 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
TEVA-EFAVIRENZ	02389762	600 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	EFAVIRENZ 600 MG TABLET	$1.27584	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)

6.4.2.2. Antiretrovirals > Non-nucleoside reverse transcriptase inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid: 600 mg tablet

Safety signals and safety-related labeling changes

US FDA 8 Nov 2023 SUSTIVA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 Nov 2023 SUSTIVA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Mar 2021 PRAC signal: Microcephaly
Action for MAH: update of the product information: No
EMA PRAC 1 Oct 2020 PRAC signal: Microcephaly
Action for MAH: update of the product information: No
US FDA 29 Oct 2019 ATRIPLA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Oct 2019 SYMFI — 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 Oct 2019 SYMFI LO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; 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
EMA PRAC 26 Oct 2017 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 10 Oct 2013 PRAC signal: Interaction with Ginkgo biloba
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2013 PRAC signal: Interaction with Ginkgo biloba
Action for MAH: update of the product information: Yes

All safety entries for efavirenz →

Combinations containing Efavirenz

Efavirenz + emtricitabine + 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.