Is Canagliflozin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Canagliflozin, including INVOKANA 100 mg film-coated tablet (100 mg, Film-coated tablet, SAR 159.00); INVOKANA 300 mg film-coated tablet (300 mg, Film-coated tablet, SAR 159.00).

Is Canagliflozin approved by the US FDA?

Drugs@FDA lists 3 application product lines for Canagliflozin, including INVOKANA (Prescription); CANAGLIFLOZIN (Prescription); CANAGLIFLOZIN (Discontinued).

Is Canagliflozin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Canagliflozin: Invokana.

Is Canagliflozin 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 Canagliflozin?

EMA PRAC: 7 entries; US FDA: 3 entries; MHRA: 1 entry (latest 2026-08-11).

Active substance

Canagliflozin

SFDA 2
US FDA 3
EMA 1
Health Canada 8
US price lines 2
NHS prices 2
WHO EML 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INVOKANA 100 mg film-coated tablet	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 159.00	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
INVOKANA 300 mg film-coated tablet	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 159.00	NCE · Prescription	JANSSEN PHARMACEUTICA N.V	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
INVOKANA	100MG; 300MG	tablet · oral	JANSSEN PHARMS	Prescription	29 Mar 2013
CANAGLIFLOZIN	100MG; 300MG	tablet · oral	APOTEX	Prescription	14 Apr 2026
CANAGLIFLOZIN	100MG; 300MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	20 Apr 2026

EMA European Union — centrally authorised medicines

Invokana Janssen-Cilag International NV · Authorised · authorised 15 Nov 2013 · ATC A10BK02

Therapeutic indication (EMA)

Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications 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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-CANAGLIFLOZIN	02564556	100 MG	TABLET · ORAL	APOTEX INC
APO-CANAGLIFLOZIN	02564564	300 MG	TABLET · ORAL	APOTEX INC
AURO-CANAGLIFLOZIN	02510367	100 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CANAGLIFLOZIN	02510375	300 MG	TABLET · ORAL	AURO PHARMA INC
INVOKANA	02425483	100 MG	TABLET · ORAL	JANSSEN INC
INVOKANA	02425491	300 MG	TABLET · ORAL	JANSSEN INC
JAMP CANAGLIFLOZIN	02543486	100 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP CANAGLIFLOZIN	02543494	300 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	INVOKANA 100 MG TABLET	$19.12691	per EA	23 Sep 2026
US NADAC	INVOKANA 300 MG TABLET	$19.12476	per EA	23 Sep 2026
NHS Drug Tariff	Canagliflozin 100mg tablets	£39.20	30 tablet	1 Oct 2026
NHS Drug Tariff	Canagliflozin 300mg tablets	£39.20	30 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 11 Aug 2026 INVOKAMET — 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 INVOKAMET 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 3 Jun 2026 INVOKANA — 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
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 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
MHRA 15 Jun 2016 Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients
A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
EMA PRAC 14 Apr 2016 PRAC signal: Potential increased risk of lower limb amputations
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 canagliflozin →

Combinations containing Canagliflozin

Canagliflozin + metformin

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.