Repaglinide Accord

Authorised

This medicine is authorised for use in the European Union

repaglinide

Overview

This is a summary of the European public assessment report (EPAR) for Repaglinide Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Repaglinide Accord.

What is Repaglinide Accord?

Repaglinide Accord is a medicine that contains the active substance repaglinide. It is available as round tablets (0.5 mg, 1 mg and 2 mg).

Repaglinide Accord is a ‘generic medicine’. This means that Repaglinide Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called NovoNorm.

What is Repaglinide Accord used for?

Repaglinide Accord is used in patients who have type-2 diabetes (non-insulin-dependent diabetes). It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise. Repaglinide Accord may also be used with metformin (another anti-diabetes medicine) in type-2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.

The medicine can only be obtained with a prescription.

How is Repaglinide Accord used?

Repaglinide Accord is taken before meals, normally up to 15 minutes before each main meal. The dose is adjusted to give the best control. A doctor should regularly test the patient’s blood glucose to find the lowest effective dose. Repaglinide Accord can also be used for type-2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.

The recommended starting dose is 0.5 mg. This dose may need to be increased after one or two weeks.

If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.

Repaglinide Accord is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.

How does Repaglinide Accord work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Repaglinide Accord helps the pancreas to produce more insulin at mealtimes and is used to control type-2 diabetes.

How has Repaglinide Accord been studied?

Because Repaglinide Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Repaglinide Accord?

Because Repaglinide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Repaglinide Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Repaglinide Accord has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, the CHMP’s view was that, as for NovoNorm, the benefit outweighs the identified risk. The Committee recommended that Repaglinide Accord be given marketing authorisation.

Other information about Repaglinide Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Accord on 22 December 2011.

For more information about treatment with Repaglinide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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
• 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

AdoptedReference Number: EMA/9712/2012

CHMP summary of positive opinion for Repaglinide Accord

AdoptedReference Number: EMA/CHMP/812168/2011