Ebymect

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dapagliflozin / metformin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 26/11/2019

Authorisation details

Product details
Name
Ebymect
Agency product number
EMEA/H/C/004162
Active substance
  • dapagliflozin propanediol monohydrate
  • metformin hydrochloride
International non-proprietary name (INN) or common name
dapagliflozin / metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD15
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
15/11/2015
Contact address
SE-151-85 Sodertalje
Sweden

Product information

17/10/2019 Ebymect - EMEA/H/C/004162 - WS/1637

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

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.

Assessment history

Changes since initial authorisation of medicine

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