Invokana

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canagliflozin

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

Overview

Invokana is a diabetes medicine that contains the active substance canagliflozin. It is used together with diet and exercise to treat adults with type 2 diabetes.

Invokana can be used on its own in patients who cannot take metformin (another diabetes medicine) or it can be used as an ‘add-on’ to other diabetes medicines.

This EPAR was last updated on 06/08/2020

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
16
Date of issue of marketing authorisation valid throughout the European Union
15/11/2013
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

26/06/2020 Invokana - EMEA/H/C/002649 - II/0046

Contents

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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, cardiovascular and renal 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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