This is a summary of the European public assessment report (EPAR) for Trajenta. 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 Trajenta.
Therapeutic Indication
### Therapeutic indication Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as **monotherapy** - in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. as **combination therapy** - in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Therapeutic Area (MeSH)
ATC Code
A10BH05
ATC Item
linagliptin
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| linagliptin | N/A | 利格列汀 |
EMA Name
Trajenta
Medicine Name
Trajenta
Aliases
N/ANo risk management plan link.
