Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Date of authorisation: 22/05/2014, Revision: 33, Status: Authorised
Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Date of authorisation: 22/05/2014, Revision: 33, Status: Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Jardiance is a medicine used to treat type 2 diabetes, chronic (long-term) heart failure and chronic kidney disease.
In type 2 diabetes, Jardiance is used in adults whose condition is not controlled well enough. It is used with appropriate diet and exercise in patients who cannot take metformin (another treatment for diabetes). It can also be used as an ‘add-on’ treatment to other diabetes medicines. In chronic heart failure (a condition in which the heart does not pump blood around the body as well as it should), Jardiance is used in adults to treat symptoms of the disease. Jardiance is also used in adults with chronic kidney disease.
Jardiance contains the active substance empagliflozin.
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How is Jardiance used?
Jardiance is available as tablets and can only be obtained with a prescription.
For type 2 diabetes, heart failure and chronic kidney disease, the recommended dose is 10 mg once a day.
For type 2 diabetes, the dose may be increased in suitable patients; if Jardiance is used in combination with insulin or medicines that make the body produce insulin, the doses of these medicines may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
For more information about using Jardiance, see the package leaflet or contact your healthcare provider.
How does Jardiance work?
The active substance in Jardiance, empagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops the kidneys passing glucose from the blood into the urine. Patients with diabetes have high levels of glucose in the blood. By blocking the action of SGLT2, empagliflozin causes the kidneys to pass more glucose into the urine, thereby reducing the levels of glucose in the blood.
Blocking the action of SGLT2 also increases the removal of salt and water in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood. This improves heart function in patients with heart failure and also preserves kidney function in patients with chronic kidney disease, regardless of having diabetes.
What benefits of Jardiance have been shown in studies?
Type 2 diabetes
A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients. Jardiance was compared with placebo (a dummy treatment) when used alone or added to treatment with other diabetes medicines (metformin, pioglitazone, or metformin plus either pioglitazone or sulphonylurea). The main measure of effectiveness was the change 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, after 24 weeks of treatment. When blood sugar levels decrease, HbA1c levels also decrease.
All the studies showed a modest but clinically meaningful decrease in HbA1c with Jardiance compared with placebo: in the study investigating use of Jardiance without other medicines, the reduction in HbA1c was 0.74% more than placebo with the 10 mg dose and 0.85% more than placebo with the 25 mg dose. Modest but clinically meaningful reductions in HbA1c were also seen when Jardiance was added to other medicines. In addition, the results indicated that Jardiance treatment was associated with a beneficial fall in body weight and blood pressure.
Supportive evidence was provided from a further six studies. Some of these were continuations of the main studies, and suggested that the benefits of the medicine continued with longer therapy. There was also supportive evidence suggesting benefit when the medicine was combined with insulin.
Another main study showed that adding Jardiance to usual treatment reduced harmful cardiovascular (heart and blood vessels) effects. The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke). The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. On average, patients in the study were followed up for 3.1 years. In those receiving Jardiance, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Heart failure
In the treatment of heart failure, irrespective of diabetes, a beneficial effect of Jardiance was shown in two studies involving 3,730 and 5,988 patients, respectively, who were given either Jardiance or placebo.
In the first study, 19.4% (361 out of 1,863) of patients who took Jardiance for around 14 months were hospitalised for heart failure or died of cardiovascular causes, compared with 24.7% (462 out of 1,867) of those who took placebo.
In the second study, 13.8% (415 out of 2,997) of patients who took Jardiance for around 23 months were hospitalised for heart failure or died of cardiovascular causes, compared with 17.1% (511 out of 2,991) of those who took placebo.
Chronic kidney disease
Jardiance was effective in treating adult patients with chronic kidney disease, irrespective of whether they had diabetes, based on a study involving over 6,600 patients. When Jardiance was added to their usual treatment for chronic kidney disease, 13.1% (432 out of 3,304) of patients taking Jardiance experienced worsening of their kidney function or died because of heart or kidney problems compared with 16.9% (558 out of 3,305) of those taking placebo; the risk was 28% lower with Jardiance than with placebo.
What are the risks associated with Jardiance?
For the full list of side effects and restrictions with Jardiance, see the package leaflet.
The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar) when the medicine is taken with sulphonylurea or insulin (other treatments for type 2 diabetes), and reduced amounts of fluids in the body when used to treat heart failure.
Why is Jardiance authorised in the EU?
Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes when given alone or in combination with other diabetes medicines with different mechanisms of action. Jardiance was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease and patients who suffered from long-term heart failure irrespective of whether they had diabetes. In patients with chronic kidney disease, irrespective of having diabetes, Jardiance was also shown to reduce the risk of kidney function decline or death due to kidney or heart problems, when added to the patient’s usual treatment. In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Jardiance. Regarding safety, overall the side effects were considered manageable.
The European Medicines Agency therefore decided that Jardiance’s benefits are greater than its risks and it can be authorised for use in the EU.
What measures are being taken to ensure the safe and effective use of Jardiance?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jardiance have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Jardiance are continuously monitored. Suspected side effects reported with Jardiance are carefully evaluated and any necessary action taken to protect patients.
Other information about Jardiance
Jardiance received a marketing authorisation valid throughout the EU on 22 May 2014.
This overview was last updated in 07-2023.
Jardiance : EPAR - Summary for the public
Reference Number:
EMA/193010/2022
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Jardiance : EPAR - Risk-management-plan summary
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Jardiance : EPAR - Risk Management Plan
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Product information
Jardiance : EPAR - Product Information
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Latest procedure affecting product information:
VR/0000333055
24/03/2026
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).
Jardiance : EPAR - All Authorised presentations
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Product details
Name of medicine
Jardiance
Active substance
empagliflozin
International non-proprietary name (INN) or common name
empagliflozin
Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Heart Failure
- Renal Insufficiency, Chronic
Anatomical therapeutic chemical (ATC) code
A10BK03
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
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.
Authorisation details
EMA product number
EMEA/H/C/002677
Marketing authorisation holder
Boehringer Ingelheim International GmbH
Binger Strasse 173 55216 Ingelheim Germany
Opinion adopted
20/03/2014
Marketing authorisation issued
22/05/2014
Revision
33
Assessment history
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Changes since initial authorisation of medicine
Jardiance : EPAR - Procedural steps taken and scientific information after authorisation
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24/03/2026
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Jardiance : EPAR - Procedural steps taken and scientific information after authorisation (archive)
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04/02/2015
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Jardiance-H-C-PSUSA-00010388-202404 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
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25/06/2025
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Jardiance-H-C-002677-II-0076- : EPAR - Assessment report - variation
Adopted
Reference Number:
EMA/542987/2023
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First published:
07/02/2024
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CHMP post-authorisation summary of positive opinion for Jardiance (II-76)
Adopted
Reference Number:
EMA/CHMP/483404/2023
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10/11/2023
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Jardiance-H-C-002677-0074 : EPAR - Assessment report - variation
Adopted
Reference Number:
EMA/CHMP/137741/2014
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04/09/2023
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CHMP post-authorisation summary of positive opinion for Jardiance (II-74)
Adopted
Reference Number:
EMA/281506/2023
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23/06/2023
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Jardiance-H-C-PSUSA-00010388-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
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EMA/193077/2022
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30/03/2022
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Jardiance-H-C-002677-II-0060 : EPAR - Assessment report - Variation
Adopted
Reference Number:
EMA/102340/2022
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30/03/2022
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CHMP post-authorisation summary of positive opinion for Jardiance (II-0060)
Adopted
Reference Number:
EMA/CHMP/36445/2022
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28/01/2022
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Jardiance-H-C-002677-II-0055 : EPAR - Assessment report - Variation
Adopted
Reference Number:
EMA/CHMP/275072/2021
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23/07/2021
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CHMP post-authorisation summary of positive opinion for Jardiance (II-55)
Adopted
Reference Number:
EMA/CHMP/275069/2021
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21/05/2021
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Jardiance-H-C-PSUSA-00010388-201704 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
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EMA/19602/2018
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11/01/2018
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11/01/2018
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Jardiance-H-C-PSUSA-00010388-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
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EMA/493907/2017
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03/08/2017
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03/08/2017
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Jardiance-H-A20-1442-C-2677-0023 : EPAR - Assessment Report - Article 20
Adopted
Reference Number:
EMA/PRAC/637349/2016
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05/07/2017
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05/07/2017
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Jardiance-H-A20-1442-C-2677-0023 : EPAR - Scientific Conclusion - Article 20
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Jardiance-H-C-2677-II-0014 : EPAR - Assessment Report
Adopted
Reference Number:
EMA/11728/2017
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First published:
30/03/2017
Last updated:
30/03/2017
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Jardiance-H-C-2677-P46-0007 : EPAR - Assessment Report
Adopted
Reference Number:
EMA/70001/2017
English (EN) (874.29 KB - PDF)
First published:
01/02/2017
Last updated:
01/02/2017
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CHMP post-authorisation summary of positive opinion for Jardiance
Adopted
Reference Number:
EMA/398392/2016
English (EN) (110.53 KB - PDF)
First published:
16/12/2016
Last updated:
16/12/2016
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Jardiance-H-C-PSUSA-00010388-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Reference Number:
EMA/342499/2016
English (EN) (108.16 KB - PDF)
First published:
23/09/2016
Last updated:
23/09/2016
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Jardiance-H-C-2677-A20-1419-0007 : EPAR - Assessment Report - Article 20
Adopted
Reference Number:
EMA/PRAC/50218/2016
English (EN) (264.09 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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Jardiance : EPAR - Scientific Conclusion
English (EN) (44.81 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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Other languages (22)
български (BG) (91.68 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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español (ES) (56.69 KB - PDF)
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19/05/2016
Last updated:
19/05/2016
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19/05/2016
Last updated:
19/05/2016
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19/05/2016
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19/05/2016
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19/05/2016
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19/05/2016
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eesti keel (ET) (54.72 KB - PDF)
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19/05/2016
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19/05/2016
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ελληνικά (EL) (93.41 KB - PDF)
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19/05/2016
Last updated:
19/05/2016
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français (FR) (57.6 KB - PDF)
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19/05/2016
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19/05/2016
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hrvatski (HR) (84.25 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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italiano (IT) (55.18 KB - PDF)
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19/05/2016
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19/05/2016
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latviešu valoda (LV) (84.2 KB - PDF)
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19/05/2016
Last updated:
19/05/2016
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lietuvių kalba (LT) (89.77 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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magyar (HU) (76.78 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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Malti (MT) (93.09 KB - PDF)
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19/05/2016
Last updated:
19/05/2016
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Nederlands (NL) (56.44 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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polski (PL) (79.13 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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português (PT) (56.52 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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română (RO) (89.07 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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slovenčina (SK) (87.42 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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slovenščina (SL) (83.89 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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Suomi (FI) (55.44 KB - PDF)
First published:
19/05/2016
Last updated:
19/05/2016
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svenska (SV) (57.31 KB - PDF)
First published:
19/05/2016
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19/05/2016
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Initial marketing authorisation documents
Jardiance : EPAR - Public assessment report
Adopted
Reference Number:
EMA/CHMP/137741/2014
English (EN) (1.24 MB - PDF)
First published:
16/06/2014
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CHMP summary of positive opinion for Jardiance
Adopted
Reference Number:
EMA/CHMP/157961/2014
English (EN) (63.64 KB - PDF)
First published:
21/03/2014
Last updated:
02/04/2014
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News on Jardiance
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023
10/11/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
23/06/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 2022
28/01/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
21/05/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
16/12/2016
SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
12/02/2016
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2015
12/06/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014
21/03/2014
More information on Jardiance
- EMEA-000828-PIP01-09-M09 - paediatric investigation plan
- SGLT2 inhibitors - referral
- SGLT2 inhibitors (previously canagliflozin) - referral
- EMEA-000828-PIP04-16-M03 - paediatric investigation plan
- EMEA-000828-PIP05-17 - paediatric investigation plan
- EMEA-000828-PIP06-18 - paediatric investigation plan
- EMEA-000828-PIP07-21 - paediatric investigation plan
- Effect of Glucagon-Like Peptide-1 Receptor Agonists on the Risk of Non-Arteritic Anterior Ischemic Optic Neuropathy Among Older Adults with Type 2 Diabetes: A US. Medicare Active-Comparator New-User Cohort Study - post-authorisation study
- GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONISTS AND OBSTRUCTIVE SLEEP APNEA RISK USING MEDICARE DATA 2007 - 2019 - post-authorisation study
- A regulatory non-interventional study to monitor the safety and efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean patients with Chronic Kidney Disease (CKD) - post-authorisation study
- Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients with chronic heart failure in Japan (PMS of JARDIANCE in CHF) - post-authorisation study
- A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE® (empagliflozin 10mg, 25mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE® rPMS in Korean patients with T2DM) - post-authorisation study
- Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients with type 2 Diabetes Mellitus (Japanese JARDIANCE PMS, long term) - post-authorisation study
- Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus (Japanese PMS, elderly patients) - post-authorisation study
- A regulatory requirement non-interventional study to monitor the safety and effectiveness of Jardiance® (empagliflozin, 10mg) in Korean patients with chronic heart failure (NYHA class II-IV) - post-authorisation study
- Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients with Chronic Kidney Disease in Japan - post-authorisation study
- Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors (PASS renal, liver injury, infection, ketoacidosis) - post-authorisation study
- Comparative cardiovascular and renal effectiveness and safety of Empagliflozin and other SGLT2i in patients with type 2 diabetes (T2D), with and without baseline kidney disease in the United States - post-authorisation study
- Clinical and economic impact of 2nd line initiation of empagliflozin after metformin, as compared to 2nd line initiation of sulfonylurea after metformin in patients with type 2 diabetes and cardiovascular disease - post-authorisation study
- Post-authorization safety study in patients with type 2 diabetes mellitus to assess the incidence of ketoacidosis, severe complications of urinary tract infection, volume depletion, and dehydration among patients treated with EMPAGLIFLOZIN or DPP-4 inhibitors in Saudi Arabia (Post-authorization safety study in type 2 diabetic) - post-authorisation study
- A non-interventional study of the effectiveness and safety outcomes in patients with heart failure and preserved ejection fraction (HFpEF) initiating Jardiance in China: A sub-study of the post-arketing study of Jardiance among patients with heart failure in China - post-authorisation study
- Non-interventional study of the effectiveness and safety of Jardiance in patients with heart failure (HF) of reduced ejection fraction (HFrEF) compared to guideline-recommended non- SGLT2i therapy regimens in China: A sub-study of the postmarketing study of Jardiance among patients with heart failure in China - post-authorisation study
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This page was last updated on
24/03/2026
Summary
Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Date of authorisation: 22/05/2014, Revision: 33, Status: Authorised