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Ebymect (dapagliflozin;metformin)

Region

🇪🇺 EU

Active substance

dapagliflozin;metformin

Company

AstraZeneca AB

Status

Authorised

Therapeutic area

Diabetes Mellitus, Type 2

CHMP opinion

Wed 23 Sep 2015

EU approval

Sun 15 Nov 2015

Application

EMEA/H/C/004162

ATC

A10BD15

Official record

www.ema.europa.eu

Indication

Type 2 diabetes mellitus 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 and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. Type 1 diabetes mellitus Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ? 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Xigduo Authorised · AstraZeneca AB

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.