Vildagliptin / Metformin hydrochloride Accord (vildagliptin;metformin hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- vildagliptin;metformin hydrochloride
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Thu 24 Mar 2022
- Designations
- Generic
- Application
- EMEA/H/C/005738
- ATC
- A10BD08
- Official record
- www.ema.europa.eu
Indication
Vildagliptin/Metformin hydrochloride Accord 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.
Follow Vildagliptin / Metformin hydrochloride Accord
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.