Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

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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 Icandra. 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 Icandra.

This EPAR was last updated on 06/12/2018

Authorisation details

Product details
Name
Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
Agency product number
EMEA/H/C/001050
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 Icandra (previously Vildagliptin / metformin hydrochloride Novartis) - EMEA/H/C/001050 - N/0073

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

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

  • Icandra 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.
  • Icandra 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.
  • Icandra 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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