Icandra (previously Vildagliptin / metformin hydrochloride Novartis)

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vildagliptin / metformin

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

Overview

Icandra 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 taken 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 the blood glucose. 

Icandra 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 Icandra (informed consent).

This EPAR was last updated on 10/03/2022

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
24
Date of issue of marketing authorisation valid throughout the European Union
30/11/2008
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

01/03/2022 Icandra (previously Vildagliptin / metformin hydrochloride Novartis) - EMEA/H/C/001050 - N/0099

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

  • Combinations of oral blood glucose lowering drugs

Therapeutic indication

Icandra 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 glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Assessment history

Changes since initial authorisation of medicine

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