Vokanamet
canagliflozin / metformin
Table of contents
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.
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List item
Vokanamet : EPAR - Summary for the public (PDF/84.72 KB)
First published: 15/05/2014
Last updated: 15/05/2014
EMA/119828/2014 -
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Vokanamet : EPAR - Risk-management-plan summary (PDF/107.64 KB)
First published: 15/05/2014
Last updated: 28/07/2023
Authorisation details
Product details | |
---|---|
Name |
Vokanamet
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Agency product number |
EMEA/H/C/002656
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
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Anatomical therapeutic chemical (ATC) code |
A10BD16
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
22
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Date of issue of marketing authorisation valid throughout the European Union |
23/04/2014
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Contact address |
Turnhoutseweg 30 |
Product information
15/06/2023 Vokanamet - EMEA/H/C/002656 - II/0067/G
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
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.