Synjardy
empagliflozin / metformin
Table of contents
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.
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List item
Synjardy : EPAR - Summary for the public (PDF/86.41 KB)
First published: 12/06/2015
Last updated: 05/07/2017
EMA/355552/2015 -
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Synjardy : EPAR - Risk-management-plan summary (PDF/56.45 KB)
First published: 12/06/2015
Last updated: 12/06/2015
EMA/217413/2015
Authorisation details
Product details | |
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Name |
Synjardy
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Agency product number |
EMEA/H/C/003770
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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 |
A10BD20
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Publication details | |
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Marketing-authorisation holder |
Boehringer Ingelheim
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Revision |
24
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Date of issue of marketing authorisation valid throughout the European Union |
27/05/2015
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Contact address |
Binger Strasse 173 |
Product information
24/03/2022 Synjardy - EMEA/H/C/003770 - WS2171
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 201727/01/2017
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14/10/2016
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12/02/2016
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12/06/2015
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27/03/2015