Qtrilmet (metformin hydrochloride;saxagliptin;dapagliflozin)
- Region
- 🇪🇺 EU
- Active substance
- metformin hydrochloride;saxagliptin;dapagliflozin
- Company
- AstraZeneca AB
- Status
- Withdrawn
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 19 Sep 2019
- EU approval
- Mon 11 Nov 2019
- Application
- EMEA/H/C/004910
- ATC
- A10BD
- Official record
- www.ema.europa.eu
Indication
Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control. when already being treated with metformin and saxagliptin and dapagliflozin.
Regulatory milestones
No milestones recorded in the last year.
Follow Qtrilmet
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.