Jardiance

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empagliflozin

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

Overview

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

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

This EPAR was last updated on 28/06/2018

Authorisation details

Product details
Name
Jardiance
Agency product number
EMEA/H/C/002677
Active substance
empagliflozin
International non-proprietary name (INN) or common name
empagliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BK03
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
15
Date of issue of marketing authorisation valid throughout the European Union
22/05/2014
Contact address
Binger Strasse 173
55216 Ingelheim
Germany

Product information

31/05/2018 Jardiance - EMEA/H/C/002677 - 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

Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy when metformin is considered inappropriate due to intolerance
  • in addition to other medicinal products for the treatment of diabetes
  • For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Assessment history

Changes since initial authorisation of medicine

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