Invokana

canagliflozin

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Invokana is a diabetes medicine that contains the active substance canagliflozin. It is used together with diet and exercise to treat adults with type 2 diabetes.

Invokana can be used on its own in patients who cannot take metformin (another diabetes medicine) or it can be used as an ‘add-on’ to other diabetes medicines.

: Invokana is available as tablets and can only be obtained with a prescription. The tablets are taken once a day, preferably before the first meal of the day. The recommended starting dose is 100 mg once a day. If appropriate, the dose can be increased to 300 mg once a day.
For more information about using Invokana, see the package leaflet or contact your doctor or pharmacist.

: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. This leads to high levels of glucose in the blood and other complications.
The active substance in Invokana, canagliflozin, works by blocking a protein in the kidneys called sodium‑glucose co‑transporter 2 (SGLT2). SGLT2 absorbs glucose from the urine back into the bloodstream as the blood is filtered in the kidneys. By blocking the action of SGLT2, Invokana causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood.
SGLT2 also absorbs sodium from the urine into the bloodstream. Blocking the action of SGLT2 leads to a reduction of sodium in the blood reducing the pressure in the kidney and slowing the progression of diabetic kidney disease.

Invokana’s effects on blood glucose levels have been evaluated in 9 main studies involving a total of around 10,000 patients with type 2 diabetes. In all of the studies, the main measure of effectiveness was the reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

Invokana was shown to be more effective than placebo, and at least as effective as comparator medicines, at reducing the levels of HbA1c when used alone or in combination with other diabetes medicines:

When Invokana was used on its own at a dose of 100 mg, it decreased HbA1c levels by 0.91 percentage points more than placebo after 26 weeks, while the 300 mg dose led to a reduction of 1.16 percentage points more than placebo.
Across the studies that looked at Invokana when used as add-on to one or two other diabetes medicines, the reductions in HbA1c levels after 26 weeks compared with placebo ranged from 0.76 percentage points to 0.92 percentage points with the 300 mg dose, and from 0.62 percentage points to 0.74 percentage points with the 100 mg dose.
When Invokana was used as add-on to insulin at a dose of 300 mg, it decreased HbA1c levels by 0.73 percentage points more than placebo after 18 weeks, while the 100 mg dose led to a reduction of 0.65 percentage points more than placebo.
Invokana was also shown to be at least as effective as the diabetes medicines glimepiride and sitagliptin after 52 weeks of treatment.
The study in patients with moderately reduced kidney function showed that the effects of Invokana were reduced in these patients, but still clinically relevant: the reduction of HbA1c levels compared with placebo was 0.3 percentage points with the 100 mg dose.
The study in older patients showed that Invokana had clinically relevant effects in patients above 75 years of age with HbA1c reductions compared with placebo of 0.70 percentage points and 0.57 percentage points with the 300 mg and 100 mg doses, respectively

In addition, Invokana’s effects on the heart and diabetic kidney disease were studied in 3 main studies:

In two studies involving over 10,000 patients who had heart disease or were at risk of developing it, treatment with Invokana for 149 weeks reduced the risk of heart problems or stroke: in the Invokana group there were 27 occurrences of a heart attack, stroke or death from problems in the heart and blood circulation per 1000 patient-years compared with 32 occurrences with placebo.
Invokana was also shown to be effective in slowing the progression in diabetic kidney disease in patients with type 2 diabetes. In a study in 4,000 patients with mildly or moderately reduced kidney function, patients received either Invokana or placebo on top of standard treatment. With Invokana, 11% of patients (245 out of 2,202) had substantial worsening of kidney function or died from kidney and heart problems compared with 16% (340 out of 2,199) of patients on placebo. When compared to placebo, the effect on kidney function was largely independent from the blood-glucose-lowering effect of Invokana.

: The most common side effects (which may affect more than 1 in 10 people) with Invokana are hypoglycaemia (low blood glucose levels) when used together with insulin or a sulphonylurea, vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida) and urinary tract infection (infection of the structure that carries the urine).
For the full list of side effects of Invokana, see the package leaflet.

: The European Medicines Agency decided that Invokana’s benefits are greater than its risks and it can be authorised for use in the EU. Invokana was shown to be effective at controlling blood glucose levels in patients with type 2 diabetes and at reducing diabetic kidney disease and heart complications. Regarding its safety, this was considered similar to other medicines of the same class (SGLT2 inhibitors). Important side effects identified included dehydration and urinary tract infection, but these were considered manageable.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invokana have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Invokana are continuously monitored. Side effects reported with Invokana are carefully evaluated and any necessary action taken to protect patients.

: Invokana received a marketing authorisation valid throughout the EU on 15 November 2013.

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Invokana : EPAR - Medicine overview (PDF/172.36 KB)

First published: 29/11/2013
Last updated: 06/08/2020
EMA/368477/2020
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  (PDF/203.46 KB)
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- Greek
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- Hungarian
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- Italian
  (PDF/147.65 KB)
- Latvian
  (PDF/218.12 KB)
- Lithuanian
  (PDF/172.46 KB)
- Maltese
  (PDF/203.22 KB)
- Polish
  (PDF/201.93 KB)
- Portuguese
  (PDF/149.42 KB)
- Romanian
  (PDF/178.95 KB)
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  (PDF/172.08 KB)
- Slovenian
  (PDF/171.77 KB)
- Spanish
  (PDF/177.28 KB)
- Swedish
  (PDF/176.12 KB)
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Invokana : EPAR - Risk-management-plan summary (PDF/98.14 KB)

First published: 03/10/2018
Last updated: 27/02/2023

This EPAR was last updated on 30/05/2023

Authorisation details

Product details
Name	Invokana
Agency product number	EMEA/H/C/002649
Active substance	canagliflozin
International non-proprietary name (INN) or common name	canagliflozin
Therapeutic area (MeSH)	Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code	A10BK02

Publication details
Marketing-authorisation holder	Janssen-Cilag International NV
Revision	22
Date of issue of marketing authorisation valid throughout the European Union	15/11/2013
Contact address	Turnhoutseweg 30 B-2340 Beerse Belgium

Product information

29/05/2023 Invokana - EMEA/H/C/002649 - N/0064

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Invokana : EPAR - Product Information (PDF/853 KB) (updated)

First published: 29/11/2013
Last updated: 30/05/2023
- Bulgarian
  (PDF/827.3 KB)
- Croatian
  (PDF/907.91 KB)
- Czech
  (PDF/515.05 KB)
- Danish
  (PDF/574.24 KB)
- Dutch
  (PDF/735.81 KB)
- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Icelandic
  (PDF/1.14 MB)
- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
  (PDF/584.62 KB)
- Romanian
  (PDF/1.01 MB)
- Slovak
  (PDF/916.4 KB)
- Slovenian
  (PDF/1.88 MB)
- Spanish
  (PDF/593.16 KB)
- Swedish
  (PDF/593.61 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Invokana : EPAR - All Authorised presentations (PDF/18.08 KB)

First published: 29/11/2013
Last updated: 29/11/2013
- Bulgarian
  (PDF/35.79 KB)
- Croatian
  (PDF/27.31 KB)
- Czech
  (PDF/23.17 KB)
- Danish
  (PDF/16.42 KB)
- Dutch
  (PDF/17.58 KB)
- Estonian
  (PDF/17.73 KB)
- Finnish
  (PDF/15.89 KB)
- French
  (PDF/15.54 KB)
- German
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- Greek
  (PDF/34.11 KB)
- Hungarian
  (PDF/24.07 KB)
- Icelandic
  (PDF/14.84 KB)
- Italian
  (PDF/16.3 KB)
- Latvian
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- Lithuanian
  (PDF/37.42 KB)
- Maltese
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- Norwegian
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- Polish
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- Portuguese
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- Romanian
  (PDF/31.58 KB)
- Slovak
  (PDF/23.52 KB)
- Slovenian
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- Spanish
  (PDF/16.21 KB)
- Swedish
  (PDF/15.81 KB)

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Invokana is indicated for the treatment of adults 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.

Assessment history

Changes since initial authorisation of medicine

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Invokana : EPAR - Procedural steps taken and scientific information after authorisation (PDF/278.24 KB) (updated)

First published: 04/09/2014
Last updated: 30/05/2023
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Invokana-H-C-2649-II-46 : EPAR - Assessment Report - Variation (PDF/4.44 MB)

Adopted

First published: 06/08/2020
EMA/306073/2020
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Invokana-H-C-PSUSA-00010077-201903 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/118.38 KB)

First published: 12/02/2020
EMA/67311/2020
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Invokana-H-A20-1442-C-2649-0018 : EPAR - Assessment Report- Article 20 (PDF/254.07 KB)

Adopted

First published: 05/07/2017
Last updated: 05/07/2017
EMA/PRAC/637349/2016
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Invokana-H-A20-1442-C-2649-0018 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

First published: 05/07/2017
Last updated: 05/07/2017
- Bulgarian
  (PDF/84.18 KB)
- Croatian
  (PDF/76.27 KB)
- Czech
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- Danish
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- Dutch
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- Estonian
  (PDF/40.46 KB)
- Finnish
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- French
  (PDF/42.93 KB)
- German
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- Greek
  (PDF/84.71 KB)
- Hungarian
  (PDF/60.56 KB)
- Icelandic
  (PDF/40.74 KB)
- Italian
  (PDF/40.72 KB)
- Latvian
  (PDF/76.13 KB)
- Lithuanian
  (PDF/72.25 KB)
- Maltese
  (PDF/83.36 KB)
- Norwegian
  (PDF/40.5 KB)
- Polish
  (PDF/62.96 KB)
- Portuguese
  (PDF/42.06 KB)
- Romanian
  (PDF/78.32 KB)
- Slovak
  (PDF/70.79 KB)
- Slovenian
  (PDF/75.63 KB)
- Spanish
  (PDF/41.99 KB)
- Swedish
  (PDF/41.68 KB)
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Invokana-H-C-2649-A20-1419-0011 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Adopted

First published: 19/05/2016
Last updated: 19/05/2016
EMA/PRAC/50218/2016
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Invokana : EPAR - Scientific Conclusion (PDF/44.81 KB)

First published: 12/05/2016
Last updated: 12/05/2016
- Bulgarian
  (PDF/71.82 KB)
- Croatian
  (PDF/64.39 KB)
- Czech
  (PDF/70.24 KB)
- Danish
  (PDF/36.99 KB)
- Dutch
  (PDF/36.58 KB)
- Estonian
  (PDF/34.87 KB)
- Finnish
  (PDF/35.58 KB)
- French
  (PDF/37.74 KB)
- German
  (PDF/39.88 KB)
- Greek
  (PDF/73.56 KB)
- Hungarian
  (PDF/56.94 KB)
- Italian
  (PDF/35.32 KB)
- Latvian
  (PDF/64.37 KB)
- Lithuanian
  (PDF/69.91 KB)
- Maltese
  (PDF/73.22 KB)
- Polish
  (PDF/59.28 KB)
- Portuguese
  (PDF/36.67 KB)
- Romanian
  (PDF/69.21 KB)
- Slovak
  (PDF/67.54 KB)
- Slovenian
  (PDF/64.02 KB)
- Spanish
  (PDF/36.83 KB)
- Swedish
  (PDF/35.79 KB)
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Invokana-H-C-PSUSA-00010077-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/67.81 KB)

First published: 13/01/2016
Last updated: 13/01/2016
EMA/766757/2015
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Invokana-H-C-2649-PSUSA-00010077-201411: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/75.44 KB)

First published: 28/09/2015
Last updated: 28/09/2015
EMA/602249/2015

Invokana

Table of contents

Overview

Invokana : EPAR - Medicine overview (PDF/172.36 KB)

Invokana : EPAR - Risk-management-plan summary (PDF/98.14 KB)

Authorisation details

Product information

Invokana : EPAR - Product Information (PDF/853 KB) (updated)

Invokana : EPAR - All Authorised presentations (PDF/18.08 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Invokana : EPAR - Procedural steps taken and scientific information after authorisation (PDF/278.24 KB) (updated)

Invokana-H-C-2649-II-46 : EPAR - Assessment Report - Variation (PDF/4.44 MB)

Invokana-H-C-PSUSA-00010077-201903 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/118.38 KB)

Invokana-H-A20-1442-C-2649-0018 : EPAR - Assessment Report- Article 20 (PDF/254.07 KB)

Invokana-H-A20-1442-C-2649-0018 : EPAR - Scientific Conclusion - Article 20 (PDF/41.36 KB)

Invokana-H-C-2649-A20-1419-0011 : EPAR - Assessment Report - Article 20 (PDF/264.09 KB)

Invokana : EPAR - Scientific Conclusion (PDF/44.81 KB)

Invokana-H-C-PSUSA-00010077-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/67.81 KB)

Invokana-H-C-2649-PSUSA-00010077-201411: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/75.44 KB)

Initial marketing-authorisation documents

Invokana : EPAR - Public assessment report (PDF/1.77 MB)

CHMP summary of positive opinion for Invokana (PDF/62.92 KB)

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