Is Azilsartan + Chlortalidone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Azilsartan + Chlortalidone, including EDARBYCLOR 40 MG/12.5 MG TABLET (40,12.5 mg,mg, Film-coated tablet, SAR 71.45); EDARBYCLOR 40 MG/25 MG TABLET (40,25 mg,mg, Film-coated tablet, SAR 71.45); EZEACT PLUS 40MG/12.5MG TABLET (40,12.5 mg,mg, Tablet, SAR 71.45); EZEACT PLUS 40MG/25MG TABLET (40,25 mg,mg, Tablet, SAR 71.45).

Active substances

Azilsartan + Chlortalidone

SFDA 6
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EDARBYCLOR 40 MG/12.5 MG TABLET	40,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 71.45	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EDARBYCLOR 40 MG/25 MG TABLET	40,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 71.45	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EZEACT PLUS 40MG/12.5MG TABLET	40,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 71.45	NCE · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
EZEACT PLUS 40MG/25MG TABLET	40,25 mg,mg	Tablet · Oral use	28 Blister	SAR 71.45	NCE · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
EDARBYCLOR 80 MG/12.5 MG TABLET	80, 12.5 mg	Film-coated tablet · Oral use	28 Blister	SAR 71.45	NCE · Prescription	TAKEDA	Withdrawn by MAH · Not Marketed
EDARBYCLOR 80 MG/25 MG TABLET	80, 25 mg	Film-coated tablet · Oral use	28 Blister	SAR 71.45	NCE · Prescription	TAKEDA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HYPERTENSION

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EDARBYCLOR	02397749	12.5 MG; 40 MG	TABLET · ORAL	BAUSCH HEALTH, CANADA INC.
EDARBYCLOR	02397765	25 MG; 40 MG	TABLET · ORAL	BAUSCH HEALTH, CANADA INC.

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.