Zomarist

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vildagliptin / 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 Zomarist. 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 Zomarist.

This EPAR was last updated on 05/12/2018

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
18
Date of issue of marketing authorisation valid throughout the European Union
30/11/2008
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

07/11/2018 Zomarist - EMEA/H/C/001049 - N/0073

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Zomarist is indicated in the treatment of type-2 diabetes mellitus:

  • Zomarist 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.
  • Zomarist 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. Zomarist 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.

Assessment history

Changes since initial authorisation of medicine

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