Repaglinide Accord

Withdrawn

This medicine's authorisation has been withdrawn

repaglinide

Overview

On 29 July 2026, the European Commission withdrew the marketing authorisation for Repaglinide Accord (repaglinide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Accord Healthcare S.L.U., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Repaglinide Accord was granted marketing authorisation in the EU on 22 December 2011 for the treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016.

Repaglinide Accord is a generic medicine of NovoNorm. Beyond the reference medicine NovoNorm, there are also other generic medicines of NovoNorm authorised and marketed in the EU which could be used as an alternative. 

Repaglinide Accord : EPAR - Summary for the public

Reference Number: EMEA/H/C/002318

Product information

Repaglinide Accord : EPAR - Product Information

Reference Number: EMEA/H/C/002318

Repaglinide Accord : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Repaglinide Accord
• Active substance:
  repaglinide
• International non-proprietary name (INN) or common name:
  repaglinide
• Therapeutic area (MeSH):
  Diabetes Mellitus, Type 2
• Anatomical therapeutic chemical (ATC) code:
  A10BX02

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.

Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Authorisation details

• EMA product number:
  EMEA/H/C/002318
• 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:
  20/10/2011
• Marketing authorisation issued:
  22/12/2011
• Withdrawal of marketing authorisation:
  29/07/2026
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Repaglinide Accord : EPAR - Procedural steps taken and scientific information after authorisation

Repaglinide Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Repaglinide Accord : EPAR - Public assessment report

Adopted Reference Number: EMA/9712/2012

CHMP summary of positive opinion for Repaglinide Accord

Adopted Reference Number: EMA/CHMP/812168/2011