Zomarist

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vildagliptin / metformin

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

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).

This EPAR was last updated on 20/03/2023

Authorisation details

Product details
Name
Zomarist
Agency product number
EMEA/H/C/001049
Active substance
  • vildagliptin
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • vildagliptin
  • metformin
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
Elm Park
Merrion Road
Dublin 4
D04 A9N6 
Ireland

Product information

14/10/2022 Zomarist - EMEA/H/C/001049 - WS/2224

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

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.

Assessment history

Changes since initial authorisation of medicine

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