Basic Information
Ebymect
Regulatory Information
EMEA/H/C/004162
November 15, 2015
September 23, 2015
23
November 28, 2024
Company Information
Active Substances Detail
dapagliflozin propanediol monohydratemetformin hydrochloride
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
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.