Vokanamet

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canagliflozin / metformin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 28/07/2023

Authorisation details

Product details
Name
Vokanamet
Agency product number
EMEA/H/C/002656
Active substance
  • canagliflozin
  • metformin hydrochloride
International non-proprietary name (INN) or common name
  • canagliflozin
  • metformin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD16
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
23/04/2014
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

15/06/2023 Vokanamet - EMEA/H/C/002656 - II/0067/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

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.

Assessment history

Changes since initial authorisation of medicine

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