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 25/05/2022

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
Publication details
Marketing-authorisation holder
Boehringer Ingelheim
Revision
24
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

24/03/2022 Synjardy - EMEA/H/C/003770 - WS2171

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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