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.
Galvus : EPAR - Medicine overview (PDF/156.89 KB)
First published: 11/03/2008
Last updated: 24/08/2021
Galvus : EPAR - Risk management plan summary (PDF/194.08 KB)
First published: 29/10/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
30/09/2021 Galvus - EMEA/H/C/000771 - WS1970
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.
Drugs used in diabetes
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
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes26/03/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201221/09/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 201116/12/2011