Is Amlodipine + Valsartan 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 Amlodipine + Valsartan, including Amlovan (160,10 mg,mg, Film-coated tablet, SAR 62.90); Amlovan (160,5 mg,mg, Film-coated tablet, SAR 56.85); Amstar (160,10 mg,mg, Film-coated tablet, SAR 42.20); Amstar (160,5 mg,mg, Film-coated tablet, SAR 42.20); Avysk Plus 10/160 mg film-coated tablet (160,10 mg,mg, Film-coated tablet, SAR 56.60).

Is Amlodipine + Valsartan approved by the US FDA?

Drugs@FDA lists 11 application product lines for Amlodipine + Valsartan, including EXFORGE (Prescription); AMLODIPINE BESYLATE AND VALSARTAN (Prescription); AMLODIPINE BESYLATE AND VALSARTAN (Prescription); AMLODIPINE BESYLATE AND VALSARTAN (Prescription); AMLODIPINE BESYLATE AND VALSARTAN (Prescription).

Is Amlodipine + Valsartan authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Amlodipine + Valsartan: Copalia, Dafiro, Exforge, Amlodipine / Valsartan Mylan.

Active substances

Amlodipine + Valsartan

SFDA 25
US FDA 11
EMA 5
US price lines 6
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
Amlovan	160,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 62.90	Generic · Prescription	SPIMACO	Valid
Amlovan	160,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 56.85	Generic · Prescription	SPIMACO	Valid
Amstar	160,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 42.20	Generic · Prescription	PHARMA INTERNATIONAL CO	Valid
Amstar	160,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 42.20	Generic · Prescription	PHARMA INTERNATIONAL CO	Valid
Avysk Plus 10/160 mg film-coated tablet	160,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 56.60	Generic · Prescription	Med City Pharma	Valid
Avysk Plus 5/160 mg film-coated tablet	160,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 51.15	Generic · Prescription	Med City Pharma	Valid
EXFORGE 10 MG-160 MG F-C TABLETS	160,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 74.00	NCE · Prescription	NOVARTIS	Valid
EXFORGE 5MG-160 MG F.C. TABLETS	160,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 66.90	NCE · Prescription	NOVARTIS	Valid
LOTEVAN 10/160MG FILM COATED TABLET	160,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 62.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN 10/320MG FILM COATED TABLET	320,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 93.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN 5/160MG FILM COATED TABLET	160,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 65.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LOTEVAN 5/320MG FILM COATED TABLET	320,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 79.95	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
SENERGY 10 MG/160 MG F.C. TABLET	160,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 42.20	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
SENERGY 5 MG/160 MG F.C. TABLET	160,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 42.20	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Tenival	10,160 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 62.90	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Tenival	5,160 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 56.85	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Vittoria	320,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 83.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Vittoria	160,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 62.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Vittoria	320,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 71.95	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Vittoria	160,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 56.85	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Wamlox	5,160 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 42.20	Generic · Prescription	KRKA D D NOVO MESTO	Valid
Wamlox	10,160 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 42.20	Generic · Prescription	KRKA D D NOVO MESTO	Valid
AMLOR PLUS 10/320 mg film-coated tablet	320,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 83.90	Generic · Prescription	PFIZER SAUDI LIMITED	Suspended · Not Marketed
AMLOR PLUS 5/320 mg film-coated tablet	320,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 71.95	Generic · Prescription	PFIZER SAUDI LIMITED	Suspended · Not Marketed
EXFORGE 5MG-80MG F-C TABLETS	5, 180 mg	Film-coated tablet · Oral use	28 Blister	SAR 114.85	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
EXFORGE	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	NOVARTIS	Prescription	20 Jun 2007
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	STRIDES PHARMA INTL	Prescription	28 Mar 2013
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	MYLAN	Prescription	30 Mar 2015
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	NOVEL LABS INC	Prescription	30 Mar 2015
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	ALEMBIC	Prescription	3 Apr 2015
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;160MG; EQ 10MG BASE;320MG	tablet · oral	AUROBINDO PHARMA	Prescription	22 Apr 2016
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	HETERO LABS	Prescription	16 Sep 2016
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	MACLEODS PHARMS	Prescription	11 Oct 2024
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	LUPIN	Discontinued	30 Mar 2015
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 10MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;320MG	tablet · oral	TEVA PHARMS USA	Discontinued	30 Mar 2015
AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG; EQ 5MG BASE;320MG; EQ 10MG BASE;160MG; EQ 10MG BASE;320MG	tablet · oral	TORRENT	Discontinued	30 Mar 2015

EMA European Union — centrally authorised medicines

Copalia Novartis Europharm Limited · Authorised · authorised 15 Jan 2007 · ATC C09DB01

Therapeutic indication (EMA)

Treatment of essential hypertension. Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Dafiro Novartis Europharm Limited · Authorised · authorised 15 Jan 2007 · ATC C09DB01

Therapeutic indication (EMA)

Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Exforge Novartis Europharm Limited · Authorised · authorised 16 Jan 2007 · ATC C09DB01

Therapeutic indication (EMA)

Treatment of essential hypertension. Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Amlodipine / Valsartan Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 22 Mar 2016 · ATC C09DB01

Therapeutic indication (EMA)

Treatment of essential hypertension. Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Imprida Novartis Europharm Ltd · Withdrawn · authorised 17 Jan 2007 · ATC C09DB01

Therapeutic indication (EMA)

Treatment of essential hypertension. Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMLODIPINE-VALSARTAN 10-160 MG	$0.32969	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN 10-320 MG	$0.43177	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN 5-160 MG	$0.26403	per EA	23 Sep 2026
US NADAC	AMLODIPINE-VALSARTAN 5-320 MG	$0.3511	per EA	23 Sep 2026
US NADAC	EXFORGE 10-320 MG TABLET	$15.39419	per EA	7 Jan 2026
US NADAC	EXFORGE 5-160 MG TABLET	$10.65075	per EA	7 Jan 2026
NHS Drug Tariff	Amlodipine 10mg / Valsartan 160mg tablets	£26.51	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 5mg / Valsartan 160mg tablets	£26.51	28 tablet	1 Oct 2026
NHS Drug Tariff	Amlodipine 5mg / Valsartan 80mg tablets	£20.11	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.