Glyxambi
empagliflozin / linagliptin
Table of contents
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.
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List item
Glyxambi : EPAR - Summary for the public (PDF/83.96 KB)
First published: 24/11/2016
Last updated: 24/11/2016 -
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Glyxambi : EPAR - Risk-management-plan summary (PDF/71.1 KB)
First published: 10/12/2019
Authorisation details
Product details | |
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Name |
Glyxambi
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Agency product number |
EMEA/H/C/003833
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BD19
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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 | |
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Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
11/11/2016
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Contact address |
Product information
28/10/2020 Glyxambi - EMEA/H/C/003833 - IB/0033/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
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.