This is a summary of the European public assessment report (EPAR) for Efficib. 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 Efficib.
Therapeutic Indication
### Therapeutic indication For patients with type-2 diabetes mellitus: - Efficib 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. - Efficib 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. - Efficib is indicated as triple combination therapy with a 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. - Efficib 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 dosage of insulin and metformin alone do not provide adequate glycaemic control.
Therapeutic Area (MeSH)
N/AATC Code
A10BD07
ATC Item
metformin and sitagliptin
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
N/AINN / Common Names
N/AEMA Name
Efficib
Medicine Name
Efficib
Aliases
N/ANo risk management plan link.
