Galvus

RSS

vildagliptin

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

Overview

Galvus 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 alone when metformin (another diabetes medicine) is not suitable, or together with other diabetes medicines, including insulin, when these medicines do not provide adequate control of the blood glucose.

Galvus contains the active substance vildagliptin.

This EPAR was last updated on 26/10/2022

Authorisation details

Product details
Name
Galvus
Agency product number
EMEA/H/C/000771
Active substance
vildagliptin
International non-proprietary name (INN) or common name
vildagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH02
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
25/09/2007
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

07/07/2022 Galvus - EMEA/H/C/000771 - WS/2253

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

Drugs used in diabetes

Therapeutic indication

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:

  • as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance.
  • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
3 ratings
1 rating