Basic Information
Januvia
Regulatory Information
EMEA/H/C/000722
March 20, 2007
33
August 20, 2024
Company Information
the netherlands
Waarderweg 39 2031 BN Haarlem
Merck Sharp & Dohme BV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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 (PPAR?) agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? agonist alone do not provide adequate glycaemic control; - a PPAR? agonist (i.e. a thiazolidinedione) when use of a PPAR? agonist is appropriate and when diet and exercise plus the PPAR? 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 PPAR? agonist and metformin when use of a PPAR? 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Januvia. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Januvia.