dapagliflozin / metformin
Ebymect is a diabetes medicine that is used, together with diet and exercise in adults with type 2 diabetes. It contains the active substances dapagliflozin and metformin.
Ebymect is used:
- on its own in patients whose disease is not controlled well enough with metformin alone;
- in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Ebymect can also be used to replace dapagliflozin and metformin taken as separate tablets.
Ebymect : EPAR - Medicine overview (PDF/86.24 KB)
First published: 23/11/2015
Last updated: 28/08/2019
Ebymect : EPAR - Risk-management-plan (PDF/1.16 MB)
First published: 03/08/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
151 85 Sodertalje
30/05/2023 Ebymect - EMEA/H/C/004162 - IG1616
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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).
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Drugs used in diabetes
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 201525/09/2015