Is Dapagliflozin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 25 valid registrations of Dapagliflozin, including DIVINUS 10 mg film-coated tablet (10 mg, Film-coated tablet, SAR 151.00); DIVINUS 5 mg film-coated tablet (5 mg, Film-coated tablet, SAR 151.00); Daglozin (5 mg, Film-coated tablet, SAR 144.80); Daglozin (10 mg, Film-coated tablet, SAR 144.80); Dapagliflozin Evapharma (10 mg, Film-coated tablet, SAR 93.30).

Is Dapagliflozin approved by the US FDA?

Drugs@FDA lists 16 application product lines for Dapagliflozin, including FARXIGA (Prescription); DAPAGLIFLOZIN (Prescription); DAPAGLIFLOZIN (Prescription); DAPAGLIFLOZIN (Prescription); DAPAGLIFLOZIN (Prescription).

Is Dapagliflozin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dapagliflozin: Dapagliflozin Viatris.

Is Dapagliflozin on the WHO Model List of Essential Medicines?

Yes — 18.5.2. Hypoglycaemic agents (core list): Therapeutic equivalent to empagliflozin for Type 2 diabetes mellitus.

Are there safety signals or safety updates for Dapagliflozin?

EMA PRAC: 16 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2026-06-03).

Active substance

Dapagliflozin

SFDA 25
US FDA 16
EMA 1
Health Canada 28
US price lines 4
NHS prices 2
WHO EML 1
Safety 19

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DIVINUS 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 151.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DIVINUS 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 151.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Daglozin	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 144.80	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Daglozin	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 144.80	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Dapagliflozin Evapharma	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	Eva pharma for Industry	Valid
Dapagliflozin Evapharma	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	Eva pharma for Industry	Valid
Dapagloz	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	Apex Pharma	Valid
Dapagloz	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	Apex Pharma	Valid
Dapazin	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 153.10	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Dapazin	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 153.10	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Dapinzo	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.95	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Dapinzo	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.95	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Dapxiga	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.95	Generic · Prescription	Saudi Amarox	Valid
Dapxiga	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.95	Generic · Prescription	Saudi Amarox	Valid
Dezeroga	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 135.15	Generic · Prescription	Med City Pharma	Valid
FORXIGA 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 159.00	NCE · Prescription	AstraZeneca AB	Valid
FORXIGA 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 159.00	NCE · Prescription	AstraZeneca AB	Valid
Forsdapa	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.95	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Forsdapa	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 135.95	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Gripdi	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	APOTEX	Valid
Gripdi	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	APOTEX	Valid
Pafazin	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Pafazin	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 93.30	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Xija	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 98.20	Generic · Prescription	Cooper Pharma Arabia	Valid
Xija	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 98.20	Generic · Prescription	Cooper Pharma Arabia	Valid

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE; CONGESTIVE HEART FAILURE; DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
FARXIGA	5MG; 10MG	tablet · oral	ASTRAZENECA AB	Prescription	8 Jan 2014
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	INVENTIA	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	SANDOZ	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	MICRO LABS	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	AUROBINDO PHARMA	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	BIOCON PHARMA	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	MSN	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	AJANTA PHARMA LTD	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	MACLEODS PHARMS	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	AIZANT	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	LUPIN	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	CIPLA	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	TEVA PHARMS USA	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	ALKEM LABS LTD	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	ALEMBIC	Prescription	6 Apr 2026
DAPAGLIFLOZIN	5MG; 10MG	tablet · oral	ZYDUS PHARMS	Prescription	6 Apr 2026

EMA European Union — centrally authorised medicines

Dapagliflozin Viatris Viatris Limited · Authorised · authorised 24 Mar 2023 · ATC A10BK01

Therapeutic indication (EMA)

Type 2 diabetes mellitus Dapagliflozin Viatris 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 type 2 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 Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACCEL-DAPAGLIFLOZIN	02543184	5 MG	TABLET · ORAL	ACCEL PHARMA INC
ACCEL-DAPAGLIFLOZIN	02543192	10 MG	TABLET · ORAL	ACCEL PHARMA INC
AG-DAPAGLIFLOZIN	02533049	5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-DAPAGLIFLOZIN	02533057	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-DAPAGLIFLOZIN	02527189	5 MG	TABLET · ORAL	APOTEX INC
APO-DAPAGLIFLOZIN	02527197	10 MG	TABLET · ORAL	APOTEX INC
AURO-DAPAGLIFLOZIN	02531402	5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-DAPAGLIFLOZIN	02531410	10 MG	TABLET · ORAL	AURO PHARMA INC
DAPAGLIFLOZIN	02561328	5 MG	TABLET · ORAL	SANIS HEALTH INC
DAPAGLIFLOZIN	02561336	10 MG	TABLET · ORAL	SANIS HEALTH INC
FORXIGA	02435462	5 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
FORXIGA	02435470	10 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
GLN-DAPAGLIFLOZIN	02519852	5 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
GLN-DAPAGLIFLOZIN	02519860	10 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
JAMP DAPAGLIFLOZIN	02531364	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP DAPAGLIFLOZIN	02531372	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-DAPAGLIFLOZIN	02535297	5 MG	TABLET · ORAL	MANTRA PHARMA INC
M-DAPAGLIFLOZIN	02535300	10 MG	TABLET · ORAL	MANTRA PHARMA INC
NRA-DAPAGLIFLOZIN	02538334	5 MG	TABLET · ORAL	NORA PHARMA INC
NRA-DAPAGLIFLOZIN	02538342	10 MG	TABLET · ORAL	NORA PHARMA INC
PMS-DAPAGLIFLOZIN	02531550	5 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-DAPAGLIFLOZIN	02531569	10 MG	TABLET · ORAL	PHARMASCIENCE INC
PRO-DAPAGLIFLOZIN	02537656	5 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-DAPAGLIFLOZIN	02537664	10 MG	TABLET · ORAL	PRO DOC LIMITEE
RIVA-DAPAGLIFLOZIN	02528975	5 MG	TABLET · ORAL	LABORATOIRE RIVA INC.

3 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DAPAGLIFLOZIN 10 MG TABLET	$0.18391	per EA	23 Sep 2026
US NADAC	DAPAGLIFLOZIN 5 MG TABLET	$0.16272	per EA	23 Sep 2026
US NADAC	FARXIGA 10 MG TABLET	$12.07703	per EA	23 Sep 2026
US NADAC	FARXIGA 5 MG TABLET	$12.07577	per EA	23 Sep 2026
NHS Drug Tariff	Dapagliflozin 10mg tablets	£2.32	28 tablet	1 Oct 2026
NHS Drug Tariff	Dapagliflozin 5mg tablets	£2.67	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
Therapeutic equivalent to empagliflozin for Type 2 diabetes mellitus

Safety signals and safety-related labeling changes

US FDA 3 Jun 2026 QTERN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 7 May 2026 PRAC signal: Lichen sclerosus
Action for MAH: update of the product information: No
EMA PRAC 7 May 2026 PRAC signal: Lichen sclerosus
Action for MAH: update of the product information: No
EMA PRAC 7 May 2026 PRAC signal: Lichen sclerosus
Action for MAH: update of the product information: No
EMA PRAC 7 May 2026 PRAC signal: Lichen sclerosus
Action for MAH: update of the product information: No
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 26 Oct 2023 PRAC signal: Acquired phimosis and phimosis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Jun 2023 PRAC signal: Acquired phimosis and phimosis
Action for MAH: update of the product information: No
MHRA 10 Dec 2021 Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus
The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapagliflozin are unchanged.
US FDA 24 Jan 2020 QTERNMET XR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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

All safety entries for dapagliflozin →

Combinations containing Dapagliflozin

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.