Basic Information
Vildagliptin / Metformin hydrochloride Accord
Regulatory Information
EMEA/H/C/005738
March 24, 2022
December 16, 2021
3
April 4, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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).
Overview Summary
Vildagliptin/Metformin hydrochloride Accord is a diabetes medicine that is used in addition to diet and exercise to improve control of blood glucose (sugar) levels in adults with type 2 diabetes. It is used: - in patients whose blood glucose levels are not adequately controlled by metformin alone; - in patients who are already taking a combination of vildagliptin and metformin as separate tablets; - together with other diabetes medicines, including insulin, when these medicines do not provide adequate control of blood glucose. Vildagliptin/Metformin hydrochloride Accord is a ‘generic medicine’. This means that it contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Eucreas. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf). Vildagliptin/Metformin hydrochloride Accord contains the active substances vildagliptin and metformin hydrochloride.