Vokanamet

RSS

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 12/05/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
23/04/2014
Contact address
Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

27/08/2018 Vokanamet - EMEA/H/C/002656 - II/0034

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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