Jardiance (empagliflozin)
- Region
- 🇪🇺 EU
- Active substance
- empagliflozin
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2; Heart Failure; Renal Insufficiency, Chronic
- CHMP opinion
- Thu 20 Mar 2014
- EU approval
- Thu 22 May 2014
- Application
- EMEA/H/C/002677
- ATC
- A10BK03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Synjardy Authorised · Boehringer Ingelheim
- 🇪🇺 Glyxambi Authorised · Boehringer Ingelheim International GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.