Icandra (previously Vildagliptin / metformin hydrochloride Novartis) (vildagliptin;metformin)
- Region
- 🇪🇺 EU
- Active substance
- vildagliptin;metformin
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- EU approval
- Sun 30 Nov 2008
- Application
- EMEA/H/C/001050
- ATC
- A10BD08
- Official record
- www.ema.europa.eu
Indication
Icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zomarist Authorised · Novartis Europharm Limited
- 🇪🇺 Eucreas Authorised · Novartis Europharm Limited
- 🇪🇺 Vildagliptin / Metformin hydrochloride Accord Authorised · Accord Healthcare S.L.U.
Follow Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
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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.