Vokanamet (canagliflozin;metformin)
- Region
- 🇪🇺 EU
- Active substance
- canagliflozin;metformin
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- EU approval
- Wed 23 Apr 2014
- Application
- EMEA/H/C/002656
- ATC
- A10BD16
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.