Is Amlodipine + Hydrochlorothiazide + Valsartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 34 valid registrations of Amlodipine + Hydrochlorothiazide + Valsartan, including AMLOVAN-HCT 10/160/12.5MG F.C.TABLET (160,12.5,10 mg,mg,mg, Film-coated tablet, SAR 54.15); AMLOVAN-HCT 10/160/25MG F.C.TABLET (160,25,10 mg,mg,mg, Film-coated tablet, SAR 54.15); AMLOVAN-HCT 10/320/25MG F.C.TABLET (320,25,10 mg,mg,mg, Film-coated tablet, SAR 89.80); AMLOVAN-HCT 5/160//25MG F.C.TABLET (160,25,5 mg,mg,mg, Film-coated tablet, SAR 46.35); AMLOVAN-HCT 5/160/12.5MG F.C.TABLET (160,12.5,5 mg,mg,mg, Film-coated tablet, SAR 46.35).

Is Amlodipine + Hydrochlorothiazide + Valsartan approved by the US FDA?

Drugs@FDA lists 7 application product lines for Amlodipine + Hydrochlorothiazide + Valsartan, including EXFORGE HCT (Prescription); AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription); AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription); AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription); AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (Discontinued).

Is Amlodipine + Hydrochlorothiazide + Valsartan authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Amlodipine + Hydrochlorothiazide + Valsartan: Exforge HCT, Copalia HCT, Dafiro HCT.

Is Amlodipine + Hydrochlorothiazide + Valsartan on the WHO Model List of Essential Medicines?

Yes — 12.3. Antihypertensive medicines (core list): Essential hypertension.

Active substances

Amlodipine + Hydrochlorothiazide + Valsartan

SFDA 34
US FDA 7
EMA 4
US price lines 6
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AMLOVAN-HCT 10/160/12.5MG F.C.TABLET	160,12.5,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 54.15	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AMLOVAN-HCT 10/160/25MG F.C.TABLET	160,25,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 54.15	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AMLOVAN-HCT 10/320/25MG F.C.TABLET	320,25,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 89.80	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AMLOVAN-HCT 5/160//25MG F.C.TABLET	160,25,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 46.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AMLOVAN-HCT 5/160/12.5MG F.C.TABLET	160,12.5,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 46.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
ARBAVASC HCT 160/10/12.5 mg Film-coated Tablet	160,12.5,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 66.85	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ARBAVASC HCT 160/10/25 mg Film-coated Tablet	160,25,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 66.85	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ARBAVASC HCT 160/5/12.5 mg Film-coated Tablet	160,12.5,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 57.20	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ARBAVASC HCT 160/5/25 mg Film-coated Tablet	160,25,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 57.20	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Avysk Trio	160,5,12.5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 46.35	Generic · Prescription	Med City Pharma	Valid
Avysk Trio	160,5,25 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 46.35	Generic · Prescription	Med City Pharma	Valid
Avysk Trio	160,10,12.5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 54.15	Generic · Prescription	Med City Pharma	Valid
EXFORGE HCT 10MG/160MG/12.5MG FILM COATED TABLET	160,12.5,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 83.00	NCE · Prescription	NOVARTIS	Valid
EXFORGE HCT 10MG/160MG/25MG FILM COATED TABLET	160,25,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 83.00	NCE · Prescription	NOVARTIS	Valid
EXFORGE HCT 10MG/320MG/25MG FILM COATED TABLET	320,25,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 111.50	NCE · Prescription	NOVARTIS	Valid
EXFORGE HCT 5MG/160MG/12.5MG FILM COATED TABLET	160,12.5,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 71.00	NCE · Prescription	NOVARTIS	Valid
EXFORGE HCT 5MG/160MG/25MG FILM COATED TABLET	160,25,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 71.00	NCE · Prescription	NOVARTIS	Valid
LOTEVAN PLUS 10MG/160MG/25MG FILM COATED TABLET	160,25,10 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 74.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN PLUS 10MG/320MG/25MG FILM COATED TABLET	320,25,10 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 99.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN PLUS 5MG/160MG/12.5MG FILM COATED TABLET	160,12.5,5 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN PLUS 5MG/160MG/25MG FILM COATED TABLET	160,25,5 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN PLUS10MG/160MG/12.5MG FILM COATED TABLET	160,12.5,10 mg,mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 74.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MILORA HCT	160,12.5,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 60.15	Generic · Prescription	Pharco International pharmaceutical company	Valid
MILORA HCT	160,12.5,5 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 51.50	Generic · Prescription	Pharco International pharmaceutical company	Valid
MILORA HCT	160,25,10 mg,mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 60.15	Generic · Prescription	Pharco International pharmaceutical company	Valid

9 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
EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;12.5MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG	tablet · oral	NOVARTIS	Prescription	30 Apr 2009
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;12.5MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG	tablet · oral	STRIDES PHARMA INTL	Prescription	1 Jun 2015
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;12.5MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG	tablet · oral	AUROBINDO PHARMA	Prescription	19 Dec 2017
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;12.5MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG	tablet · oral	MACLEODS PHARMS	Prescription	7 Jan 2025
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG; EQ 10MG BASE;12.5MG;160MG	tablet · oral	TEVA PHARMS	Discontinued	25 Sep 2012
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;12.5MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG	tablet · oral	LUPIN	Discontinued	3 Jun 2015
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG; EQ 5MG BASE;25MG;160MG; EQ 10MG BASE;12.5MG;160MG; EQ 10MG BASE;25MG;160MG; EQ 10MG BASE;25MG;320MG	tablet · oral	TORRENT	Discontinued	3 Jun 2015

EMA European Union — centrally authorised medicines

Exforge HCT Novartis Europharm Limited · Authorised · authorised 15 Oct 2009 · ATC C09DX01

Therapeutic indication (EMA)

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.

Copalia HCT Novartis Europharm Limited · Authorised · authorised 3 Nov 2009 · ATC C09DX01

Therapeutic indication (EMA)

Dafiro HCT Novartis Europharm Limited · Authorised · authorised 3 Nov 2009 · ATC C09DX01

Therapeutic indication (EMA)

Imprida HCT Novartis Europharm Ltd. · Lapsed · authorised 15 Oct 2009 · ATC C09DX01

Therapeutic indication (EMA)

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMLODIPINE-VALSARTAN-HYDROCHLOROTHIAZIDE 10-160-12.5 MG TAB	$4.9435	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN-HYDROCHLOROTHIAZIDE 10-160-25 MG TAB	$6.08879	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN-HYDROCHLOROTHIAZIDE 10-320-25 MG TAB	$5.44347	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN-HYDROCHLOROTHIAZIDE 5-160-12.5 MG TAB	$4.8615	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN-HYDROCHLOROTHIAZIDE 5-160-25 MG TAB	$4.23865	per EA	23 Sep 2026
US NADAC	EXFORGE HCT 10-320-25 MG TAB	$15.44773	per EA	7 Jan 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)

12.3. Antihypertensive medicines · core
Essential hypertension
Oral > Solid > dosage form: 160 mg + 5 mg + 12.5 mg; 160 mg + 5 mg + 25 mg; 160 mg + 10 mg + 12.5 mg; 160 mg + 10 mg + 25 mg; 320 mg + 10 mg + 25 mg

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.