Is Irbesartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 22 valid registrations of Irbesartan, including APROVEL 150MG TAB (150 mg, Tablet, SAR 63.00); APROVEL 300MG TAB (300 mg, Film-coated tablet, SAR 77.00); ARENA 150MG TABLET (150 mg, Tablet, SAR 45.95); ARENA 300MG TABLET (300 mg, Tablet, SAR 58.90); BERESAR 150 mg Film-coated Tablet (150 mg, Film-coated tablet, SAR 40.55).

Is Irbesartan approved by the US FDA?

Drugs@FDA lists 25 application product lines for Irbesartan, including AVAPRO (Prescription); IRBESARTAN (Prescription); IRBESARTAN (Prescription); IRBESARTAN (Prescription); IRBESARTAN (Prescription).

Is Irbesartan authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Irbesartan: Aprovel, Karvea, Irbesartan Zentiva (previously Irbesartan Winthrop), Ifirmasta (previously Irbesartan Krka), Irbesartan Teva.

Are there safety signals or safety updates for Irbesartan?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2025-08-01).

Active substance

Irbesartan

SFDA 30
US FDA 25
EMA 7
Health Canada 38
US price lines 5
NHS prices 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
APROVEL 150MG TAB	150 mg	Tablet · Oral use	28 Blister	SAR 63.00	NCE · Prescription	Sanofi Clir SNC	Valid
APROVEL 300MG TAB	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 77.00	NCE · Prescription	Sanofi Clir SNC	Valid
ARENA 150MG TABLET	150 mg	Tablet · Oral use	30 Blister	SAR 45.95	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ARENA 300MG TABLET	300 mg	Tablet · Oral use	30 Blister	SAR 58.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
BERESAR 150 mg Film-coated Tablet	150 mg	Film-coated tablet · Oral use	28 Blister	SAR 40.55	Generic · Prescription	BLUEPHARMA GENERICOS,COMERCIO DE MEDICAMENTOS , S.A.	Valid
BERESAR 300 mg Film-coated Tablet	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 51.35	Generic · Prescription	BLUEPHARMA GENERICOS,COMERCIO DE MEDICAMENTOS , S.A.	Valid
Gizlan	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 29.65	Generic · Prescription	DAR ALDAWA	Valid
Gizlan	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 29.65	Generic · Prescription	DAR ALDAWA	Valid
IRBEGEN 150 mg Film Coated Tablet	150 mg	Film-coated tablet · Oral use	28 Blister	SAR 25.65	Generic · Prescription	GENEPHARM S.A.	Valid
IRBEGEN 300 mg Film Coated Tablet	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 26.85	Generic · Prescription	GENEPHARM S.A.	Valid
IRBETEL 150 mg film-coated tablet	150 mg	Film-coated tablet · Oral use	28 Blister	SAR 53.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
IRBETEL 300 mg film-coated tablet	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 65.75	Generic · Prescription	SPIMACO ADDWAEIH	Valid
IROVEL 150 mg film-coated tablet	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 48.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IROVEL 300 mg film-coated tablet	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 59.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IRSOTAN 150 mg Film Coated Tablet	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 43.40	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
IRSOTAN 300 mg Film Coated Tablet	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 53.25	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Ribex	150 mg	Film-coated tablet · Oral use	28 Blister	SAR 21.30	Generic · Prescription	Laboratories SOTHEMA	Valid
Ribex	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 26.65	Generic · Prescription	Laboratories SOTHEMA	Valid
VIVAZAC 150MG F.C.TABLET	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 26.85	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
VIVAZAC 300MG F.C.TABLET	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 26.85	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
ZANSOR 150MG F.C.TABLET	150 mg	Film-coated tablet · Oral use	28 Blister	SAR 40.50	Generic · Prescription	DAMMAM PHARMA	Valid
ZANSOR 300MG F.C.TABLET	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 49.70	Generic · Prescription	DAMMAM PHARMA	Valid
APROVEL 150MG TAB	150 mg	Tablet · Oral use	28 Blister	SAR 78.50	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
APROVEL 150MG TAB	150 mg	Tablet · Oral use	28 Blister	SAR 78.50	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed
APROVEL 300MG TAB	300 mg	Film-coated tablet · Oral use	28 Blister	SAR 96.40	NCE · Prescription	sanofi-aventis	Withdrawn by MAH · Not Marketed

5 more — full table

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE; CORONARY ARTERY DISEASE; HYPERTENSION; SICKLE CELL DISEASE - ALBUMINURIA MANAGEMENT; SYSTEMIC LUPUS ERYTHEMATOSUS

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

Product	Strength	Form · route	Applicant	Status	First approved
AVAPRO	150MG; 300MG	tablet · oral	SANOFI AVENTIS US	Prescription	30 Sep 1997
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	TEVA PHARMS	Prescription	30 Mar 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	SANDOZ	Prescription	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	ZYDUS PHARMS USA INC	Prescription	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	HETERO LABS LTD V	Prescription	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	PRINSTON INC	Prescription	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	MACLEODS PHARMS LTD	Prescription	3 Oct 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	ALEMBIC PHARMS LTD	Prescription	15 Oct 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	CHARTWELL MOLECULAR	Prescription	14 Nov 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	JUBILANT GENERICS	Prescription	23 Feb 2015
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	UNICHEM	Prescription	7 Dec 2015
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	SCIEGEN PHARMS	Prescription	7 Dec 2015
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	HISUN PHARM HANGZHOU	Prescription	14 Jun 2016
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	AMNEAL PHARMS	Prescription	17 Apr 2018
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	MSN	Prescription	4 Nov 2025
AVAPRO	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	SANOFI AVENTIS US	Discontinued	30 Sep 1997
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	YILING	Discontinued	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	CHARTWELL RX	Discontinued	27 Sep 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	WATSON LABS INC	Discontinued	12 Oct 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	HIKMA PHARMS	Discontinued	15 Oct 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	APOTEX INC	Discontinued	15 Oct 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	LUPIN LTD	Discontinued	15 Oct 2012
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	AJANTA PHARMA LTD	Discontinued	10 Dec 2015
IRBESARTAN	75MG; 150MG; 300MG	tablet · oral	IPCA LABS LTD	Discontinued	22 May 2024

EMA European Union — centrally authorised medicines

Aprovel Sanofi Winthrop Industrie · Authorised · authorised 26 Aug 1997 · ATC C09CA04

Therapeutic indication (EMA)

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.

Karvea Sanofi Winthrop Industrie · Authorised · authorised 26 Aug 1997 · ATC C09CA04

Therapeutic indication (EMA)

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Irbesartan Zentiva (previously Irbesartan Winthrop) Zentiva k.s. · Authorised · authorised 19 Jan 2007 · ATC C09CA04

Therapeutic indication (EMA)

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.

Ifirmasta (previously Irbesartan Krka) Krka, d.d., Novo mesto · Authorised · authorised 1 Dec 2008 · ATC C09CA04

Therapeutic indication (EMA)

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Irbesartan Teva Teva B.V. · Authorised · authorised 30 Oct 2009 · ATC C09CA04

Therapeutic indication (EMA)

Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Irbesartan BMS Bristol-Myers Squibb Pharma EEIG · Withdrawn · authorised 19 Jan 2007 · ATC C09CA04

Therapeutic indication (EMA)

Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).

Sabervel Pharmathen S.A. · Expired · authorised 13 Apr 2012 · ATC C09CA04

Therapeutic indication (EMA)

Sabervel is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-IRBESARTAN	02548216	75 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-IRBESARTAN	02548224	150 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-IRBESARTAN	02548232	300 MG	TABLET · ORAL	ANGITA PHARMA INC.
AVAPRO	02237924	150 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
AVAPRO	02237925	300 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
IRBESARTAN	02372347	75 MG	TABLET · ORAL	SANIS HEALTH INC
IRBESARTAN	02372371	150 MG	TABLET · ORAL	SANIS HEALTH INC
IRBESARTAN	02372398	300 MG	TABLET · ORAL	SANIS HEALTH INC
IRBESARTAN	02385287	75 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
IRBESARTAN	02385295	150 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
IRBESARTAN	02385309	300 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
JAMP IRBESARTAN	02545225	75 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP IRBESARTAN	02545233	150 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP IRBESARTAN	02545241	300 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-IRBESARTAN	02524813	75 MG	TABLET · ORAL	MANTRA PHARMA INC
M-IRBESARTAN	02524821	150 MG	TABLET · ORAL	MANTRA PHARMA INC
M-IRBESARTAN	02524848	300 MG	TABLET · ORAL	MANTRA PHARMA INC
MINT-IRBESARTAN	02422980	75 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-IRBESARTAN	02422999	150 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-IRBESARTAN	02423006	300 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
NB-IRBESARTAN	02560070	75 MG	TABLET · ORAL	NB PHARMA INC.
NB-IRBESARTAN	02560089	150 MG	TABLET · ORAL	NB PHARMA INC.
NB-IRBESARTAN	02560097	300 MG	TABLET · ORAL	NB PHARMA INC.
PMS-IRBESARTAN	02317060	75 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-IRBESARTAN	02317079	150 MG	TABLET · ORAL	PHARMASCIENCE INC

13 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AVAPRO 150 MG TABLET	$7.3449	per EA	23 Sep 2026
US NADAC	AVAPRO 300 MG TABLET	$8.79188	per EA	23 Sep 2026
US NADAC	IRBESARTAN 150 MG TABLET	$0.10705	per EA	23 Sep 2026
US NADAC	IRBESARTAN 300 MG TABLET	$0.16228	per EA	23 Sep 2026
US NADAC	IRBESARTAN 75 MG TABLET	$0.08228	per EA	23 Sep 2026
NHS Drug Tariff	Irbesartan 150mg tablets	£2.23	28 tablet	1 Oct 2026
NHS Drug Tariff	Irbesartan 300mg tablets	£1.81	28 tablet	1 Oct 2026
NHS Drug Tariff	Irbesartan 75mg tablets	£1.46	28 tablet	1 Oct 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 1 Aug 2025 AVALIDE — 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 1 Aug 2025 AVAPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
EMA PRAC 31 Oct 2024 PRAC signal: Intestinal angioedema
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jul 2024 PRAC signal: Intestinal angioedema
Action for MAH: update of the product information: No

All safety entries for irbesartan →

Combinations containing Irbesartan

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.