Is Nevirapine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Nevirapine.

Is Nevirapine approved by the US FDA?

Drugs@FDA lists 26 application product lines for Nevirapine, including NEVIRAPINE (Prescription); NEVIRAPINE (Prescription); NEVIRAPINE (Prescription); NEVIRAPINE (Prescription); NEVIRAPINE (Prescription).

Is Nevirapine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nevirapine: Viramune.

Is Nevirapine 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 Nevirapine?

EMA PRAC: 2 entries; US FDA: 3 entries (latest 2024-07-22).

Active substance

Nevirapine

SFDA 1
US FDA 26
EMA 2
Health Canada 3
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
VIRAMUNE 200MG TAB	200 mg	Tablet · Oral use	60 Blister	SAR 664.05	NCE · Prescription	BOEHRINGER INGELHEIM	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
NEVIRAPINE	200MG	tablet · oral	AUROBINDO	Prescription	22 May 2012
NEVIRAPINE	50MG/5ML	suspension · oral	AUROBINDO	Prescription	22 May 2012
NEVIRAPINE	200MG	tablet · oral	CIPLA	Prescription	22 May 2012
NEVIRAPINE	200MG	tablet · oral	HETERO LABS LTD III	Prescription	22 May 2012
NEVIRAPINE	200MG	tablet · oral	MYLAN PHARMS INC	Prescription	22 May 2012
NEVIRAPINE	200MG	tablet · oral	MICRO LABS LTD	Prescription	22 May 2012
NEVIRAPINE	400MG	tablet, extended release · oral	SANDOZ	Prescription	3 Apr 2014
NEVIRAPINE	400MG	tablet, extended release · oral	MYLAN	Prescription	27 Oct 2014
NEVIRAPINE	50MG/5ML	suspension · oral	CIPLA	Prescription	3 Aug 2017
NEVIRAPINE	400MG	tablet, extended release · oral	MACLEODS PHARMS	Prescription	6 Oct 2017
NEVIRAPINE	200MG	tablet · oral	MACLEODS PHARMS	Prescription	14 Jan 2019
VIRAMUNE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BOEHRINGER INGELHEIM	Discontinued	21 Jun 1996
VIRAMUNE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	suspension · oral	BOEHRINGER INGELHEIM	Discontinued	11 Sep 1998
VIRAMUNE XR	400MG; 100MG	tablet, extended release · oral	BOEHRINGER INGELHEIM	Discontinued	25 Mar 2011
NEVIRAPINE	200MG	tablet · oral	STRIDES PHARMA	Discontinued	22 May 2012
NEVIRAPINE	200MG	tablet · oral	PRINSTON INC	Discontinued	22 May 2012
NEVIRAPINE	200MG	tablet · oral	PHARMOBEDIENT	Discontinued	22 May 2012
NEVIRAPINE	200MG	tablet · oral	APOTEX INC	Discontinued	22 May 2012
NEVIRAPINE	200MG	tablet · oral	TECH ORGANIZED	Discontinued	22 May 2012
NEVIRAPINE	400MG	tablet, extended release · oral	APOTEX	Discontinued	3 Apr 2014
NEVIRAPINE	400MG; 100MG	tablet, extended release · oral	ALVOGEN	Discontinued	10 Jul 2015
NEVIRAPINE	400MG	tablet, extended release · oral	CIPLA	Discontinued	15 Oct 2015
NEVIRAPINE	100MG	tablet, extended release · oral	PHARMOBEDIENT	Discontinued	9 Nov 2015
NEVIRAPINE	100MG	tablet, extended release · oral	AUROBINDO PHARMA	Discontinued	23 Nov 2016
NEVIRAPINE	400MG	tablet, extended release · oral	AUROBINDO PHARMA	Discontinued	28 Feb 2017

1 more — full table

EMA European Union — centrally authorised medicines

Viramune Boehringer Ingelheim International GmbH · Authorised · authorised 4 Feb 1998 · ATC J05AG01

Therapeutic indication (EMA)

Viramune 50 mg/5 mL oral suspension and 200 mg tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. Viramune 400 mg prolonged-release tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2). Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).

Nevirapine Teva Teva B.V. · Withdrawn · authorised 30 Nov 2009 · ATC J05AG01

Therapeutic indication (EMA)

Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age. Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-NEVIRAPINE	02318601	200 MG	TABLET · ORAL	AURO PHARMA INC
JAMP NEVIRAPINE	02405776	200 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MYLAN-NEVIRAPINE	02387727	200 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NEVIRAPINE 200 MG TABLET	$0.14722	per EA	23 Sep 2026
US NADAC	NEVIRAPINE ER 400 MG TABLET	$1.5719	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 > Liquid: 50 mg per 5 mL | Oral > Solid > dispersible tablet: 50 mg | Oral > Solid > tablet: 200 mg (EML)

Safety signals and safety-related labeling changes

US FDA 22 Jul 2024 VIRAMUNE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Jul 2024 VIRAMUNE XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Jun 2022 VIRAMUNE — safety-related labeling change
Labeling sections changed: Boxed Warning; 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 nevirapine →

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.