Ebymect

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dapagliflozin / metformin

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

Overview

This is a summary of the European public assessment report (EPAR) for Ebymect. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ebymect.

For practical information about using Ebymect, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 23/01/2018

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
8
Date of issue of marketing authorisation valid throughout the European Union
15/11/2015
Contact address
SE-151-85 Sodertalje
Sweden

Product information

20/12/2017 Ebymect - EMEA/H/C/004162 - WS/1271/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

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