This is a summary of the European public assessment report (EPAR) for Vokanamet. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vokanamet. For practical information about using Vokanamet, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: * in patients not adequately controlled on their maximally tolerated doses of metformin alone * in patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control. * in patients already being treated with the combination of canagliflozin and metformin as separate tablets For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4\.4, 4\.5 and 5\.1\.
Therapeutic Area (MeSH)
ATC Code
A10BD16
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| canagliflozin | N/A | canagliflozin |
| metformin hydrochloride | N/A | metformin hydrochloride |
EMA Name
Vokanamet
Medicine Name
Vokanamet
Aliases
N/ANo risk management plan link.
