Zomarist
vildagliptin / metformin
Table of contents
Overview
Zomarist is a diabetes medicine that is used together with diet and exercise to control the blood glucose (sugar) in adults with type 2 diabetes. It is used:
- in patients whose blood glucose is insufficiently controlled with metformin alone;
- in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
- together with other diabetes medicines, including insulin, when these medicines do not provide adequate control of blood glucose.
Zomarist contains the active substances vildagliptin and metformin hydrochloride. This medicine is the same as Eucreas, which is already authorised in the EU. The company that makes Eucreas has agreed that its scientific data can be used for Zomarist (informed consent).
Authorisation details
Product details | |
---|---|
Name |
Zomarist
|
Agency product number |
EMEA/H/C/001049
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10BD08
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
30/11/2008
|
Contact address |
Vista Building |
Product information
14/10/2022 Zomarist - EMEA/H/C/001049 - WS/2224
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
Zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:
- in patients who are inadequately controlled with metformin hydrochloride alone.
- in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.
- in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.