This is a summary of the European public assessment report (EPAR) for Actos. 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 Actos.
Therapeutic Indication
### Therapeutic indication Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: - as **monotherapy:** - in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; - as **dual oral therapy** in combination with: - metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; - a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; - as **triple oral therapy** in combination with: - metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Therapeutic Area (MeSH)
N/AATC Code
A10BG03
ATC Item
pioglitazone
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| pioglitazone hydrochloride | N/A | 吡格列酮 |
EMA Name
Actos
Medicine Name
Actos
Aliases
N/ANo risk management plan link.
