Is Empagliflozin + Metformin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Empagliflozin + Metformin, including Empamac Met (12.5,1000 mg,mg, Tablet, SAR 60.50); SYNJARDY 12.5/1000 mg Film-coated Tablet (1000,12.5 mg,mg, Film-coated tablet, SAR 171.50); SYNJARDY 12.5/850 mg Film-coated Tablet (850,12.5 mg,mg, Film-coated tablet, SAR 165.80); SYNJARDY 5/1000 mg Film-coated Tablet (1000,5 mg,mg, Film-coated tablet, SAR 171.50); SYNJARDY 5/850 mg Film-coated Tablet (850,5 mg,mg, Film-coated tablet, SAR 165.80).

Is Empagliflozin + Metformin approved by the US FDA?

Drugs@FDA lists 3 application product lines for Empagliflozin + Metformin, including SYNJARDY (Prescription); SYNJARDY XR (Prescription); EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (Discontinued).

Is Empagliflozin + Metformin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Empagliflozin + Metformin: Synjardy.

Active substances

Empagliflozin + Metformin

SFDA 5
US FDA 3
EMA 1
Health Canada 6
US price lines 8
NHS prices 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Empamac Met	12.5,1000 mg,mg	Tablet · Oral use	30 Blister	SAR 60.50	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
SYNJARDY 12.5/1000 mg Film-coated Tablet	1000,12.5 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 171.50	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
SYNJARDY 12.5/850 mg Film-coated Tablet	850,12.5 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 165.80	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
SYNJARDY 5/1000 mg Film-coated Tablet	1000,5 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 171.50	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
SYNJARDY 5/850 mg Film-coated Tablet	850,5 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 165.80	NCE · Prescription	BOEHRINGER INGELHEIM	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
SYNJARDY	5MG;500MG; 5MG;1GM; 12.5MG;500MG; 12.5MG;1GM	tablet · oral	BOEHRINGER INGELHEIM	Prescription	26 Aug 2015
SYNJARDY XR	5MG;1GM; 10MG;1GM; 12.5MG;1GM; 25MG;1GM	tablet, extended release · oral	BOEHRINGER INGELHEIM	Prescription	9 Dec 2016
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	5MG;500MG; 5MG;1GM; 12.5MG;500MG; 12.5MG;1GM	tablet · oral	ZYDUS PHARMS	Discontinued	7 Jul 2022

EMA European Union — centrally authorised medicines

Synjardy Boehringer Ingelheim · Authorised · authorised 27 May 2015 · ATC A10BD20

Therapeutic indication (EMA)

Synjardy is indicated in adults and children aged 10 years and above for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: in patients insufficiently controlled on their maximally tolerated dose of metformin alone in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products in patients already being treated with the combination of empagliflozin and metformin as separate tablets. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SYNJARDY	02456575	5 MG; 500 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
SYNJARDY	02456583	5 MG; 850 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
SYNJARDY	02456591	1000 MG; 5 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
SYNJARDY	02456605	12.5 MG; 500 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
SYNJARDY	02456613	850 MG; 12.5 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
SYNJARDY	02456621	12.5 MG; 1000 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SYNJARDY 12.5-1,000 MG TABLET	$5.60127	per EA	23 Sep 2026
US NADAC	SYNJARDY 12.5-500 MG TABLET	$5.61305	per EA	23 Sep 2026
US NADAC	SYNJARDY 5-1,000 MG TABLET	$5.59938	per EA	23 Sep 2026
US NADAC	SYNJARDY 5-500 MG TABLET	$5.62273	per EA	23 Sep 2026
US NADAC	SYNJARDY XR 10-1,000 MG TABLET	$11.21863	per EA	23 Sep 2026
US NADAC	SYNJARDY XR 12.5-1,000 MG TAB	$5.59799	per EA	23 Sep 2026
US NADAC	SYNJARDY XR 25-1,000 MG TABLET	$11.19287	per EA	23 Sep 2026
US NADAC	SYNJARDY XR 5-1,000 MG TABLET	$5.61111	per EA	23 Sep 2026
NHS Drug Tariff	Empagliflozin 12.5mg / Metformin 1g tablets	£36.59	56 tablet	1 Oct 2026
NHS Drug Tariff	Empagliflozin 12.5mg / Metformin 850mg tablets	£36.59	56 tablet	1 Oct 2026
NHS Drug Tariff	Empagliflozin 5mg / Metformin 1g tablets	£36.59	56 tablet	1 Oct 2026
NHS Drug Tariff	Empagliflozin 5mg / Metformin 850mg tablets	£36.59	56 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.