Ebymect

RSS

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, to control blood glucose (sugar) levels 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 satisfactorily controlled with metformin alone;
  • in combination with other diabetes medicines, including insulin, when these medicines together with metformin are not providing adequate control of the diabetes.

Ebymect can also be used to replace dapagliflozin and metformin taken as separate tablets.

This EPAR was last updated on 05/06/2019

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
10
Date of issue of marketing authorisation valid throughout the European Union
15/11/2015
Contact address
SE-151-85 Sodertalje
Sweden

Product information

12/11/2018 Ebymect - EMEA/H/C/004162 - WS/1380

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Ebymect is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • in patients inadequately controlled on their maximally tolerated dose of metformin alone
  • in combination with other glucose lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
  • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating