Vildagliptin / Metformin hydrochloride Accord

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vildagliptin / metformin hydrochloride

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

Vildagliptin/Metformin hydrochloride Accord contains the active substances vildagliptin and metformin hydrochloride.

This EPAR was last updated on 17/06/2022

Authorisation details

Product details
Name
Vildagliptin / Metformin hydrochloride Accord
Agency product number
EMEA/H/C/005738
Active substance
  • metformin hydrochloride
  • vildagliptin
International non-proprietary name (INN) or common name
vildagliptin / metformin hydrochloride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD08
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
24/03/2022
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

Vildagliptin / Metformin hydrochloride Accord - EMEA/H/C/005738 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

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).

Assessment history

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