Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 13 June 2018

Indication(s)

Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:

As monotherapy
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.

As dual oral therapy in combination with
- metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin,
- a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
- a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.

As triple oral therapy in combination with
- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

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Category Value
Agency product number EMEA/H/C/001048
Orphan designation No
Date First Approved 19-11-2008
Type Medicinal product subject to medical prescription
Marketing authorisation holder Novartis Europharm Limited