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.
Invokana : EPAR - Summary for the public (PDF/99.85 KB)
First published: 29/11/2013
Last updated: 29/11/2013
Invokana : EPAR - Risk-management-plan summary (PDF/103.54 KB)
First published: 03/10/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
04/09/2018 Invokana - EMEA/H/C/002649 - II/0034
- 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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 201320/09/2013