Synjardy

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empagliflozin / 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 Synjardy. 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 Synjardy.

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

This EPAR was last updated on 27/06/2018

Authorisation details

Product details
Name
Synjardy
Agency product number
EMEA/H/C/003770
Active substance
  • empagliflozin
  • Metformin
International non-proprietary name (INN) or common name
empagliflozin / metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD20
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Boehringer Ingelheim GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
27/05/2015
Contact address
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

31/05/2018 Synjardy - EMEA/H/C/003770 - WS/1316

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

Synjardy 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 patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin;
  • in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Assessment history

Changes since initial authorisation of medicine

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