Data from EMC - Curated by Toby Galbraith - Last updated 10 August 2017

Licensing authority

EMA (European Medicines Agency)

Indication(s)

For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
 
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 when diet and exercise plus metformin alone do not provide adequate glycaemic control.
 - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
 - a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
 
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.
 - a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
 
Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/000722
Orphan designation No
Date First Approved 21-03-2007
Type Medicinal product subject to medical prescription
Marketing authorisation holder Merck Sharp & Dohme Ltd.