Glyxambi

RSS

empagliflozin / linagliptin

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

Overview

This is a summary of the European public assessment report (EPAR) for Glyxambi. 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 Glyxambi.

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

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Glyxambi
Agency product number
EMEA/H/C/003833
Active substance
  • empagliflozin
  • linagliptin
International non-proprietary name (INN) or common name
empagliflozin / linagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD19
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 International GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
10/11/2016
Contact address
Binger Strasse 173 55216
Ingelheim am Rhein
Germany

Product information

03/08/2018 Glyxambi - EMEA/H/C/003833 - IAIN/0014

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

Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:

  • to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;
  • when already being treated with the free combination of empagliflozin and linagliptin.

Assessment history

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