vildagliptin / metformin
This is a summary of the European public assessment report (EPAR) for Eucreas. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eucreas.
Eucreas : EPAR - Summary for the public (PDF/75.76 KB)
First published: 03/12/2007
Last updated: 20/02/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
22/05/2020 Eucreas - EMEA/H/C/000807 - IG/1222/G
- 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.
Drugs used in diabetes
Combinations of oral blood glucose lowering drugs
Eucreas is indicated in the treatment of type-2 diabetes mellitus:
- Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
- Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea.
- Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes26/03/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201221/09/2012