Is Atazanavir 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 Atazanavir, including Ataben (150 mg, Capsule, hard, SAR 1771.15); Ataben (200 mg, Capsule, hard, SAR 1771.15).

Is Atazanavir approved by the US FDA?

Drugs@FDA lists 11 application product lines for Atazanavir, including REYATAZ (Prescription); ATAZANAVIR SULFATE (Prescription); REYATAZ (Prescription); ATAZANAVIR SULFATE (Prescription); ATAZANAVIR SULFATE (Prescription).

Is Atazanavir authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Atazanavir: Reyataz, Atazanavir Viatris (previously Atazanavir Mylan).

Are there safety signals or safety updates for Atazanavir?

EMA PRAC: 5 entries; US FDA: 3 entries (latest 2025-05-12).

Active substance

Atazanavir

SFDA 6
US FDA 11
EMA 3
Health Canada 6
US price lines 2
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ataben	150 mg	Capsule, hard · Oral use	60 Blister	SAR 1771.15	Generic · Prescription	Saudi Amarox	Valid
Ataben	200 mg	Capsule, hard · Oral use	60 Blister	SAR 1771.15	Generic · Prescription	Saudi Amarox	Valid
REYATAZ 150MG CAPSULE	150 mg	Capsule · Oral use	60 Bottle	SAR 1771.15	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
REYATAZ 150MG CAPSULE	150 mg	Capsule · Oral use	60 Bottle	SAR 1771.15	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
REYATAZ 200MG CAPSULE	200 mg	Capsule · Oral use	60 Bottle	SAR 1771.15	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
REYATAZ 200MG CAPSULE	200 mg	Capsule · Oral use	60 Bottle	SAR 1771.15	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
REYATAZ	EQ 200MG BASE; EQ 300MG BASE	capsule · oral	BRISTOL MYERS SQUIBB	Prescription	20 Jun 2003
ATAZANAVIR SULFATE	EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	TEVA PHARMS USA	Prescription	22 Apr 2014
REYATAZ	EQ 50MG BASE/PACKET	powder · oral	BRISTOL MYERS SQUIBB	Prescription	2 Jun 2014
ATAZANAVIR SULFATE	EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	AUROBINDO PHARMA	Prescription	25 Jun 2018
ATAZANAVIR SULFATE	EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	LAURUS	Prescription	30 Apr 2021
ATAZANAVIR SULFATE	EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	HETERO LABS LTD III	Prescription	2 Feb 2022
REYATAZ	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	BRISTOL MYERS SQUIBB	Discontinued	20 Jun 2003
ATAZANAVIR SULFATE	EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	CIPLA	Discontinued	9 Aug 2018
ATAZANAVIR SULFATE	EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	MYLAN	Discontinued	24 Sep 2018
ATAZANAVIR SULFATE	EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	AMNEAL	Discontinued	1 Jun 2020
ATAZANAVIR SULFATE	EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE	capsule · oral	ZYDUS PHARMS	Discontinued	4 Jun 2020

EMA European Union — centrally authorised medicines

Reyataz Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 1 Mar 2004 · ATC J05AE08

Therapeutic indication (EMA)

Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2). Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1). Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2). Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).

Atazanavir Viatris (previously Atazanavir Mylan) Viatris Limited · Authorised · authorised 22 Aug 2016 · ATC J05AE08

Therapeutic indication (EMA)

Atazanavir Viatris, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Atazanavir Krka Krka, d.d., Novo mesto · Withdrawn · authorised 25 Mar 2019 · ATC J05AE08

Therapeutic indication (EMA)

Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MYLAN-ATAZANAVIR	02456877	150 MG	CAPSULE · ORAL	MYLAN PHARMACEUTICALS ULC
MYLAN-ATAZANAVIR	02456885	200 MG	CAPSULE · ORAL	MYLAN PHARMACEUTICALS ULC
MYLAN-ATAZANAVIR	02456893	300 MG	CAPSULE · ORAL	MYLAN PHARMACEUTICALS ULC
TEVA-ATAZANAVIR	02443791	150 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-ATAZANAVIR	02443813	200 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-ATAZANAVIR	02443821	300 MG	CAPSULE · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ATAZANAVIR SULFATE 200 MG CAP	$1.10873	per EA	19 Aug 2026
US NADAC	ATAZANAVIR SULFATE 300 MG CAP	$2.22639	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 12 May 2025 EVOTAZ — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Dec 2024 REYATAZ — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Dec 2024 REYATAZ — safety-related labeling change
Labeling sections changed: Contraindications; 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
EMA PRAC 9 Oct 2014 PRAC signal: Haemolytic anaemia
Action for MAH: update of the product information: No
EMA PRAC 8 May 2014 PRAC signal: Haemolytic anaemia
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2012 PRAC signal: Angioedema
Action for MAH: update of the product information: Yes

All safety entries for atazanavir →

Combinations containing Atazanavir

Atazanavir + cobicistat

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.