Is Amlodipine + Irbesartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Amlodipine + Irbesartan, including APROVASC 150MG/10MG F.C.TABLET (150,10 mg,mg, Tablet, SAR 95.65); APROVASC 150MG/5MG F.C.TABLET (150,5 mg,mg, Tablet, SAR 95.65); APROVASC 300MG/10MG F.C.TABLET (300,10 mg,mg, Tablet, SAR 135.95); APROVASC 300MG/5MG F.C.TABLET (300,5 mg,mg, Tablet, SAR 135.95); Gizamlo (300,10 mg,mg, Film-coated tablet, SAR 61.10).

Active substances

Amlodipine + Irbesartan

SFDA 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
APROVASC 150MG/10MG F.C.TABLET	150,10 mg,mg	Tablet · Oral use	28 Blister	SAR 95.65	NCE · Prescription	sanofi-aventis de Mexico, S.A. de C.V.	Valid
APROVASC 150MG/5MG F.C.TABLET	150,5 mg,mg	Tablet · Oral use	28 Blister	SAR 95.65	NCE · Prescription	sanofi-aventis de Mexico, S.A. de C.V.	Valid
APROVASC 300MG/10MG F.C.TABLET	300,10 mg,mg	Tablet · Oral use	28 Blister	SAR 135.95	NCE · Prescription	sanofi-aventis de Mexico, S.A. de C.V.	Valid
APROVASC 300MG/5MG F.C.TABLET	300,5 mg,mg	Tablet · Oral use	28 Blister	SAR 135.95	NCE · Prescription	sanofi-aventis de Mexico, S.A. de C.V.	Valid
Gizamlo	300,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 61.10	Generic · Prescription	DAR ALDAWA	Valid
Gizamlo	300,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 61.10	Generic · Prescription	DAR ALDAWA	Valid
Gizamlo	150,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 61.10	Generic · Prescription	DAR ALDAWA	Valid
REDUVASC 150MG/10MG F.C.TABLET	150,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 81.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
REDUVASC 150MG/5MG F.C.TABLET	150,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 81.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
REDUVASC 300MG/10MG F.C.TABLET	300,10 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 115.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
REDUVASC 300MG/5MG F.C.TABLET	300,5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 115.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

Indications — CHI Daman Drug Formulary

HYPERTENSION

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.