Invokana
canagliflozin
Table of contents
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.
-
List item
Invokana : EPAR - Medicine overview (PDF/172.36 KB)
First published: 29/11/2013
Last updated: 06/08/2020
EMA/368477/2020 -
-
List item
Invokana : EPAR - Risk-management-plan summary (PDF/102.63 KB)
First published: 03/10/2018
Last updated: 27/07/2023
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 NV
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
15/11/2013
|
Contact address |
Turnhoutseweg 30 |
Product information
15/06/2023 Invokana - EMEA/H/C/002649 - II/0062
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.