Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Invokana   
Auth. number : EU/1/13/884
Active substance : canagliflozin
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BX - Other oral blood glucose lowering drugs
Chemical substance: A10BX11 - canagliflozin
(See WHO ATC Index)
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 of the SmPC.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/11/2013 Centralised - Authorisation EMEA/H/C/2649 (2013)8171 of 15/11/2013
25/04/2014 Centralised - Variation EMEA/H/C/2649/II/3, 6
Updated with Decision(2015)2428 of 08/04/2015
10/04/2015 Centralised - Yearly update (2015)2428 of 8/04/2015
24/08/2015 PSUSA - Modification EMEA/H/C/PSUSA/10077/201411 (2015)5963 of 20/08/2015
18/12/2015 PSUSA - Modification EMEA/H/C/PSUSA/10077/201503 (2015)9629 of 16/12/2015
27/04/2016 Referral EMEA/H/A-20/1419/C/2649/11 (2016)2627 of 25/04/2016
30/06/2016 Centralised - Variation EMEA/H/C/2649/II/16
Updated with Decision(2017)2759 of 20/04/2017
15/09/2016 Centralised - Variation EMEA/H/C/2649/II/23
Updated with Decision(2017)2759 of 20/04/2017
24/04/2017 Referral EMEA/H/A-20/1442/C/2649/18 (2017)2759 of 20/04/2017
3/05/2017 Centralised - 2-Monthly update EMEA/H/C/2649/II/26 (2017)2956 of 28/04/2017
29/09/2017 Centralised - Variation EMEA/H/C/2649/IA/32
Updated with Decision(2018)5105 of 26/07/2018
28/11/2017 Centralised - Notification EMEA/H/C/2649/N/35
Updated with Decision(2018)5105 of 26/07/2018
15/03/2018 Centralised - Variation EMEA/H/C/2649/II/33/G
Updated with Decision(2018)5105 of 26/07/2018
30/07/2018 Centralised - Renewal EMEA/H/C/2649/R/37 (2018)5105 of 26/07/2018
6/09/2018 Centralised - 2-Monthly update EMEA/H/C/2649/II/34 (2018)5903 of 4/09/2018
5/11/2018 Centralised - Variation EMEA/H/C/2649/IB/41