This is a summary of the European public assessment report (EPAR) for Ristfor. 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 Ristfor.
Therapeutic Indication
For patients with type\-2 diabetes mellitus: * Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. * Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. * Ristfor is indicated as triple combination therapy with a peroxisome proliferator\-activated\-receptor\-gamma (PPAR?) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist. * Ristfor is also indicated as add\-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Therapeutic Area (MeSH)
ATC Code
A10BD07
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| sitagliptin | N/A | sitagliptin |
| metformin hydrochloride | N/A | metformin hydrochloride |
EMA Name
Ristfor
Medicine Name
Ristfor
Aliases
N/ANo risk management plan link.
