Vipdomet

RSS

alogliptin / 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 Vipdomet. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Vipdomet.

For practical information about using Vipdomet, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 29/11/2017

Authorisation details

Product details
Name
Vipdomet
Agency product number
EMEA/H/C/002654
Active substance
  • alogliptin benzoate
  • metformin hydrochloride
International non-proprietary name (INN) or common name
alogliptin / metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD13
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
18/09/2013
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

16/10/2017 Vipdomet - EMEA/H/C/002654 - IB/0023

Contents

  • 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.

Pharmacotherapeutic group

  • Drugs used in diabetes

  • Combinations of oral blood glucose lowering drugs

Therapeutic indication

Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:

  • as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;
  • in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;
  • in combination with insulin (i.e. triple combination therapy) 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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