← Drug database

Edistride (dapagliflozin)

Region
🇪🇺 EU
Active substance
dapagliflozin
Company
AstraZeneca AB
Status
Authorised
Therapeutic area
Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
CHMP opinion
Wed 23 Sep 2015
EU approval
Mon 09 Nov 2015
Application
EMEA/H/C/004161
ATC
A10BK01
Official record
www.ema.europa.eu

Indication

Type 2 diabetes mellitus Edistride 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 type 2 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 Edistride is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Edistride 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

Follow Edistride

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

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.