Is Empagliflozin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Empagliflozin, including EMBA (25 mg, Film-coated tablet, SAR 128.40); EMBA (10 mg, Film-coated tablet, SAR 128.40); Empamac (25 mg, Film-coated tablet, SAR 128.40); Empamac (10 mg, Film-coated tablet, SAR 128.40); JARDIANCE 10 mg film-coated tablet (10 mg, Film-coated tablet, SAR 159.00).

Is Empagliflozin approved by the US FDA?

Drugs@FDA lists 3 application product lines for Empagliflozin, including JARDIANCE (Prescription); EMPAGLIFLOZIN (Prescription); EMPAGLIFLOZIN (Discontinued).

Is Empagliflozin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Empagliflozin: Jardiance.

Is Empagliflozin on the WHO Model List of Essential Medicines?

Yes — 18.5.2. Hypoglycaemic agents (core list): Type 2 diabetes mellitus.

Are there safety signals or safety updates for Empagliflozin?

EMA PRAC: 8 entries; US FDA: 5 entries (latest 2026-08-11).

Active substance

Empagliflozin

SFDA 8
US FDA 3
EMA 1
Health Canada 2
US price lines 2
NHS prices 2
WHO EML 1
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EMBA	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 128.40	Generic · Prescription	Saudi Amarox	Valid
EMBA	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 128.40	Generic · Prescription	Saudi Amarox	Valid
Empamac	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 128.40	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Empamac	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 128.40	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
JARDIANCE 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 159.00	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
JARDIANCE 25 mg film-coated tablet	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 159.00	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
Monzeva	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.15	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Monzeva	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.15	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid

Indications — CHI Daman Drug Formulary

CONGESTIVE HEART FAILURE; DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
JARDIANCE	10MG; 25MG	tablet · oral	BOEHRINGER INGELHEIM	Prescription	1 Aug 2014
EMPAGLIFLOZIN	10MG; 25MG	tablet · oral	INVAGEN PHARMS	Prescription	22 Sep 2026
EMPAGLIFLOZIN	10MG; 25MG	tablet · oral	ZYDUS PHARMS	Discontinued	3 Aug 2022

EMA European Union — centrally authorised medicines

Jardiance Boehringer Ingelheim International GmbH · Authorised · authorised 22 May 2014 · ATC A10BK03

Therapeutic indication (EMA)

Type 2 diabetes mellitus Jardiance is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance in addition to other medicinal products for the treatment of diabetes For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Jardiance is indicated in adults for the treatment of chronic kidney disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JARDIANCE	02443937	10 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
JARDIANCE	02443945	25 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	JARDIANCE 10 MG TABLET	$11.18929	per EA	23 Sep 2026
US NADAC	JARDIANCE 25 MG TABLET	$11.1897	per EA	23 Sep 2026
NHS Drug Tariff	Empagliflozin 10mg tablets	£36.59	28 tablet	1 Oct 2026
NHS Drug Tariff	Empagliflozin 25mg tablets	£36.59	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.

WHO WHO Model List of Essential Medicines (2025)

18.5.2. Hypoglycaemic agents · core
Type 2 diabetes mellitus
Oral > Solid: 10 mg; 25 mg

Safety signals and safety-related labeling changes

US FDA 11 Aug 2026 SYNJARDY — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Aug 2026 SYNJARDY XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Aug 2026 TRIJARDY XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Oct 2025 GLYXAMBI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Oct 2025 JARDIANCE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 13 Mar 2025 PRAC signal: Sarcopenia
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2024 PRAC signal: Sarcopenia
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2024 PRAC signal: Polycythaemia
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2019 PRAC signal: New information on the known association between sodium-glucose co-transporter 2 (SGLT2) inhibitors and diabetic ketoacidosis (DKA) in surgical patients
Action for MAH: update of the product information: Yes
EMA PRAC 15 Mar 2019 PRAC signal: New information on the known association between sodium-glucose co-transporter 2 (SGLT2) inhibitors and diabetic ketoacidosis (DKA) in surgical patients
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Fournier’s gangrene
Action for MAH: update of the product information: Yes
EMA PRAC 4 Oct 2018 PRAC signal: Fournier’s gangrene
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Diabetic ketoacidosis
Action for MAH: update of the product information: No

All safety entries for empagliflozin →

Combinations containing Empagliflozin

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.