Invokana

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canagliflozin

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

Overview

This is a summary of the European public assessment report (EPAR) for Invokana. 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 Invokana.

For practical information about using Invokana, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 03/10/2018

Authorisation details

Product details
Name
Invokana
Agency product number
EMEA/H/C/002649
Active substance
canagliflozin
International non-proprietary name (INN) or common name
canagliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BK02
Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
15/11/2013
Contact address
Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

04/09/2018 Invokana - EMEA/H/C/002649 - 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

Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
  • in addition to other medicinal products for the treatment of diabetes.

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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