Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vokanamet   
Auth. number : EU/1/14/918
Active substance : canagliflozin / metformin hydrochloride
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: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD16 - metformin and canagliflozin
(See WHO ATC Index)
Indication: Vokanamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise:

• in patients insufficiently controlled on their maximally tolerated doses of metformin alone
• in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
• 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.
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
25/04/2014 Centralised - Authorisation EMEA/H/C/2656 (2014)2814 of 23/04/2014
23/10/2014 Centralised - Variation EMEA/H/C/2656/II/2
Updated with Decision(2015)5968 of 20/08/2015
4/03/2015 Centralised - Variation EMEA/H/C/2656/IG/526/G
Updated with Decision(2015)5968 of 20/08/2015
24/08/2015 PSUSA - Modification EMEA/H/C/2656/PSUSA/10077/201411 (2015)5968 of 20/08/2015
18/12/2015 PSUSA - Modification EMEA/H/C/2656/PSUSA/10077/201503 (2015)9642 of 16/12/2015
2/05/2016 Referral EMEA/H/C/2656/A-20/1419/7 (2016) 2763 of 28/04/2016
30/06/2016 Centralised - Variation EMEA/H/C/2656/II/12
Updated with Decision(2016) 8681 of 12/12/2016
15/09/2016 Centralised - Variation EMEA/H/C/2656/II/19
Updated with Decision(2016) 8681 of 12/12/2016
14/12/2016 Referral EMEA/H/A-31/1432/C/2656/13 (2016) 8681 of 12/12/2016
24/04/2017 Referral EMEA/H/A-20/1442/C/2656-14 (2017) 2768 of 20/04/2017
3/05/2017 Centralised - 2-Monthly update EMEA/H/C/2656/II/23 (2017) 2975 of 28/04/2017
24/05/2017 Centralised - Variation EMEA/H/C/2656/IB/27
Updated with Decision(2018)3463 of 28/05/2018
28/11/2017 Centralised - Variation EMEA/H/C/2656/N/35
Updated with Decision(2018)3463 of 28/05/2018
15/03/2018 Centralised - Variation EMEA/H/C/2656/II/33/G
Updated with Decision(2018)3463 of 28/05/2018
30/05/2018 Centralised - Yearly update (2018)3463 of 28/05/2018
29/08/2018 Centralised - 2-Monthly update EMEA/H/C/2656/II/34 (2018)5771 of 27/08/2018