Sitagliptin / Metformin hydrochloride Accord

Lapsed

This medicine's authorisation has lapsed

sitagliptin / metformin hydrochloride

Overview

On 22 July 2025, the marketing authorisation of Sitagliptin/Metformin Hydrochloride Accord (sitagliptin / metformin hydrochloride) ceased to be valid in the European Union (EU).

The cessation of validity is due to the fact that the marketing authorisation holder, Accord Healthcare S.L.U., had not marketed Sitagliptin/Metformin Hydrochloride Accord in the EU since its initial marketing authorisation. In accordance with provisions of the sunset clause¹, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation.

Accord Healthcare S.L.U. confirmed that the product had not been marketed the product due to commercial reasons.

Sitagliptin/Metformin Hydrochloride Accord was granted marketing authorisation in the EU on 22 July 2022 for treatment of type 2 diabetes mellitus.

The marketing authorisation was initially valid for a 5-year period.

Sitagliptin/Metformin Hydrochloride Accord is a generic medicine of Janumet. There are other generic medicinal products of Janumet authorised and marketed in the EU. Sitagliptin/Metformin Hydrochloride Accord is an identical product to Janumet, which is authorised in the EU to treat type 2 diabetes mellitus.

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¹ Article 14(4) of Regulation (EC) No 726/2004 ("sunset clause")

Sitagliptin / Metformin hydrochloride Accord : EPAR - Medicine overview

Reference Number: EMA/382461/2022

Sitagliptin / Metformin hydrochloride Accord : EPAR - Risk-management-plan summary

Product information

Sitagliptin / Metformin hydrochloride Accord : EPAR - Product information

Sitagliptin / Metformin hydrochloride Accord : EPAR - All authorised presentations

Product details

• Name of medicine:
  Sitagliptin / Metformin hydrochloride Accord
• Active substance:
  • metformin hydrochloride
  • sitagliptin hydrochloride monohydrate
• International non-proprietary name (INN) or common name:
  • sitagliptin
  • metformin hydrochloride
• Therapeutic area (MeSH):
  Diabetes Mellitus, Type 2
• Anatomical therapeutic chemical (ATC) code:
  A10BD07

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For adult patients with type 2 diabetes mellitus:

• It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
• It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
• It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist.
• It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Authorisation details

• EMA product number:
  EMEA/H/C/005850
• Generic:

  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.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  19/05/2022
• Marketing authorisation issued:
  22/07/2022
• Lapse of marketing authorisation:
  22/07/2025
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Sitagliptin / Metformin hydrochloride Accord : EPAR - Procedural steps taken and scientific information after authorisation

Sitagliptin / Metformin hydrochloride Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Sitagliptin / Metformin hydrochloride Accord : EPAR - Public assessment report

Adopted Reference Number: EMA/568807/2022

CHMP summary of positive opinion for Sitagliptin / Metformin hydrochloride Accord

Adopted Reference Number: EMA/264071/2022