This is a summary of the European public assessment report (EPAR) for Xelevia. 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 Xelevia.
Therapeutic Indication
### Therapeutic indication For adult patients with type-2 diabetes mellitus, Xelevia 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; - 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. Xelevia 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.
Therapeutic Area (MeSH)
ATC Code
A10BH01
ATC Item
sitagliptin
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sitagliptin | N/A | 西格列汀 |
EMA Name
Xelevia
Medicine Name
Xelevia
Aliases
N/ANo risk management plan link.