Anpheros Search · Treatment

Canagliflozin

Also known as: Invokana

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In short

In the European Union, canagliflozin 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, either as monotherapy when metformin is considered inappropriate or in addition to other medicinal products. In the United States, it is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. In the United States, it is also indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria. The cited sources connect canagliflozin with type 2 diabetes mellitus.

From: Source: European Medicines Agency (EMA), Invokana — EPAR, 18/12/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
1373458 canagliflozin
EMA
EMEA/H/C/002649

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Invokana

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.

Source: European Medicines Agency (EMA), Invokana — EPAR, 18/12/2025. © European Medicines Agency.

Document date: 18/12/2025 · Official document →

FDA (USA) INVOKANA

1 INDICATIONS AND USAGE INVOKANA (canagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus ( 1 ). To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( 1 ). To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria ( 1 ). Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus ( 1 ). Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 ( 1 ). Limitations of Use INVOKANA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . INVOKANA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 . INVOKANA is likely to be ineffective in this setting based upon its mechanism of action.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260611 · Official document →

Related terms in the cited sources

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External resources

Questions

What is Canagliflozin approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Invokana — EPAR, 18/12/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Invokana — EPAR, 18/12/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →