Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
vildagliptin / metformin
Table of contents
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).
Authorisation details
Product details | |
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Name |
Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
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Agency product number |
EMEA/H/C/001050
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BD08
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
25
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Date of issue of marketing authorisation valid throughout the European Union |
30/11/2008
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Contact address |
Vista Building |
Product information
14/10/2022 Icandra (previously Vildagliptin / metformin hydrochloride Novartis) - EMEA/H/C/001050 - WS2224
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Drugs used in diabetes
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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).