Is Hydrochlorothiazide + Irbesartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 29 valid registrations of Hydrochlorothiazide + Irbesartan, including ARENA PLUS 150 mg/12.5 mg Film Coated Tablet (150,12.5 mg,mg, Film-coated tablet, SAR 45.80); ARENA PLUS 300 mg/12.5 mg Film Coated Tablet (300,12.5 mg,mg, Film-coated tablet, SAR 55.95); ARENA PLUS 300 mg/25 mg Film Coated Tablet (300,25 mg,mg, Film-coated tablet, SAR 55.95); CO-IRBETEL 162.5 mg film-coated tablet (150,12.5 mg,mg, Film-coated tablet, SAR 53.55); CO-IRBETEL 312.5 mg film-coated tablet (300,12.5 mg,mg, Film-coated tablet, SAR 65.45).

Is Hydrochlorothiazide + Irbesartan approved by the US FDA?

Drugs@FDA lists 18 application product lines for Hydrochlorothiazide + Irbesartan, including AVALIDE (Prescription); IRBESARTAN AND HYDROCHLOROTHIAZIDE (Prescription); IRBESARTAN AND HYDROCHLOROTHIAZIDE (Prescription); IRBESARTAN AND HYDROCHLOROTHIAZIDE (Prescription); IRBESARTAN AND HYDROCHLOROTHIAZIDE (Prescription).

Is Hydrochlorothiazide + Irbesartan authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Hydrochlorothiazide + Irbesartan: CoAprovel, Karvezide, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Irbesartan/Hydrochlorothiazide Teva, Ifirmacombi.

Active substances

Hydrochlorothiazide + Irbesartan

SFDA 35
US FDA 18
EMA 6
Health Canada 17
US price lines 3
NHS prices 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ARENA PLUS 150 mg/12.5 mg Film Coated Tablet	150,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 45.80	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ARENA PLUS 300 mg/12.5 mg Film Coated Tablet	300,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 55.95	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ARENA PLUS 300 mg/25 mg Film Coated Tablet	300,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 55.95	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
CO-IRBETEL 162.5 mg film-coated tablet	150,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 53.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CO-IRBETEL 312.5 mg film-coated tablet	300,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 65.45	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CO-IRBETEL 325 mg film-coated tablet	300,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 65.45	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CO-Ribex	150,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 24.55	Generic · Prescription	Laboratories SOTHEMA	Valid
CO-Ribex	300,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 28.90	Generic · Prescription	Laboratories SOTHEMA	Valid
CO-Ribex	300,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 29.85	Generic · Prescription	Laboratories SOTHEMA	Valid
CO-ZANSOR 150/12.5MG F.C TABLETS	150,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 39.05	Generic · Prescription	DAMMAM PHARMA	Valid
CO-ZANSOR 300/12.5MG F.C. TABLETS	300,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 47.70	Generic · Prescription	DAMMAM PHARMA	Valid
CO-ZANSOR 300/25MG F.C. TABLETS	300,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 47.70	Generic · Prescription	DAMMAM PHARMA	Valid
COAPROVEL 300-12.5 MG TABLET	300,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 77.00	NCE · Prescription	SANOFI AVENTIS GROUPE	Valid
COAPROVEL 300-25MG F.C. TABLETS	300,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 77.00	NCE · Prescription	SANOFI AVENTIS GROUPE	Valid
Co-Aprovel 150-12.5 MG TABLET	150,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 63.00	NCE · Prescription	sanofi-aventis	Valid
Gizlan HCT	150,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 29.65	Generic · Prescription	DAR ALDAWA	Valid
Gizlan HCT	300,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 29.65	Generic · Prescription	DAR ALDAWA	Valid
Gizlan HCT	300,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 29.65	Generic · Prescription	DAR ALDAWA	Valid
IRBEGEN PLUS 150/12.5 mg Film Coated Tablet	150,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 36.00	Generic · Prescription	GENEPHARM S.A.	Valid
IRBEGEN PLUS 300/12.5 mg Film Coated Tablet	300,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 47.70	Generic · Prescription	GENEPHARM S.A.	Valid
IRBEGEN PLUS 300/25 mg Film Coated Tablet	300,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 47.70	Generic · Prescription	GENEPHARM S.A.	Valid
IRMA-HCT 300 mg / 12.5 mg	300,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 47.75	Generic · Prescription	GLOBAL PHARMA	Valid
IROVEL PLUS 150/12.5 mg film-coated tablet	150,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 48.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IROVEL PLUS 300/12.5 mg film-coated tablet	300,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 58.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IROVEL PLUS 300/25 mg film-coated tablet	300,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 58.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

10 more — full table

Indications — CHI Daman Drug Formulary

HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
AVALIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	SANOFI AVENTIS US	Prescription	30 Sep 1997
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	TEVA	Prescription	30 Mar 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	SANDOZ	Prescription	27 Sep 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	MACLEODS PHARMS LTD	Prescription	27 Sep 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	DR REDDYS LABS LTD	Prescription	27 Sep 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG; 25MG;300MG	tablet · oral	ALEMBIC	Prescription	15 Oct 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG; 25MG;300MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	22 Feb 2013
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	PRINSTON INC	Prescription	9 May 2014
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	HISUN PHARM HANGZHOU	Prescription	14 Oct 2016
AVALIDE	12.5MG;75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 25MG;300MG 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 AND HYDROCHLOROTHIAZIDE	25MG;300MG	tablet · oral	TEVA	Discontinued	30 Mar 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG; 25MG;300MG	tablet · oral	PHARMOBEDIENT	Discontinued	27 Sep 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG; 25MG;300MG	tablet · oral	HIKMA PHARMS	Discontinued	15 Oct 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	APOTEX INC	Discontinued	15 Oct 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	WATSON LABS INC	Discontinued	22 Oct 2012
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	CHARTWELL RX	Discontinued	27 Feb 2013
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG; 25MG;300MG	tablet · oral	ATLAS PHARMS LLC	Discontinued	15 Jan 2016
IRBESARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;150MG; 12.5MG;300MG	tablet · oral	UNICHEM	Discontinued	19 Sep 2017

EMA European Union — centrally authorised medicines

CoAprovel Sanofi Winthrop Industrie · Authorised · authorised 14 Oct 1998 · ATC C09DA04

Therapeutic indication (EMA)

Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Karvezide Sanofi Winthrop Industrie · Authorised · authorised 16 Oct 1998 · ATC C09DA04

Therapeutic indication (EMA)

Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) sanofi-aventis groupe · Authorised · authorised 18 Jan 2007 · ATC C09DA04

Therapeutic indication (EMA)

Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Irbesartan/Hydrochlorothiazide Teva Teva B.V. · Authorised · authorised 26 Nov 2009 · ATC C09DA04

Therapeutic indication (EMA)

Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Ifirmacombi Krka, d.d., Novo mesto · Authorised · authorised 4 Mar 2011 · ATC C09DA04

Therapeutic indication (EMA)

Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Irbesartan Hydrochlorothiazide BMS Bristol-Myers Squibb Pharma EEIG · Withdrawn · authorised 19 Jan 2007 · ATC C09DA04

Therapeutic indication (EMA)

Treatment of essential hypertension.This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AVALIDE	02241818	150 MG; 12.5 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
AVALIDE	02241819	12.5 MG; 300 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
IRBESARTAN HCT	02385317	12.5 MG; 150 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
IRBESARTAN HCT	02385325	300 MG; 12.5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
IRBESARTAN HCT	02385333	25 MG; 300 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
PMS-IRBESARTAN-HCTZ	02328518	12.5 MG; 150 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-IRBESARTAN-HCTZ	02328526	12.5 MG; 300 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-IRBESARTAN-HCTZ	02328534	300 MG; 25 MG	TABLET · ORAL	PHARMASCIENCE INC
PRO-IRBESARTAN-HCTZ	02365162	12.5 MG; 150 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-IRBESARTAN-HCTZ	02365170	12.5 MG; 300 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-IRBESARTAN-HCTZ	02365189	25 MG; 300 MG	TABLET · ORAL	PRO DOC LIMITEE
SANDOZ IRBESARTAN HCT	02337428	150 MG; 12.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ IRBESARTAN HCT	02337436	12.5 MG; 300 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ IRBESARTAN HCT	02337444	300 MG; 25 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-IRBESARTAN HCTZ	02330512	12.5 MG; 150 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-IRBESARTAN HCTZ	02330520	300 MG; 12.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-IRBESARTAN HCTZ	02330539	25 MG; 300 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AVALIDE 150-12.5 MG TABLET	$8.91093	per EA	22 Oct 2025
US NADAC	IRBESARTAN-HYDROCHLOROTHIAZIDE 150-12.5 MG TB	$0.14881	per EA	23 Sep 2026
US NADAC	IRBESARTAN-HYDROCHLOROTHIAZIDE 300-12.5 MG TB	$0.1881	per EA	23 Sep 2026
NHS Drug Tariff	Irbesartan 150mg / Hydrochlorothiazide 12.5mg tablets	£1.77	28 tablet	1 Oct 2026
NHS Drug Tariff	Irbesartan 300mg / Hydrochlorothiazide 12.5mg tablets	£2.64	28 tablet	1 Oct 2026
NHS Drug Tariff	Irbesartan 300mg / Hydrochlorothiazide 25mg tablets	£2.36	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.

Components

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.