Repaglinide Krka

Authorised

This medicine is authorised for use in the European Union

repaglinide

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Repaglinide Krka?

Repaglinide Krka is a medicine that contains the active substance repaglinide. It is available as round tablets (white: 0.5 mg; yellow: 1 mg; pink: 2 mg).

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

What is Repaglinide Krka used for?

Repaglinide Krka 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.

The medicine can only be obtained with a prescription.

How is Repaglinide Krka used?

Repaglinide Krka 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 Krka 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 Krka 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 Krka 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 Krka helps the pancreas to produce more insulin at mealtimes and is used to control type-2 diabetes.

How has Repaglinide Krka been studied?

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

What are the benefit and risk of Repaglinide Krka?

Because Repaglinide Krka is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.

Why has Repaglinide Krka been approved?

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

Other information about Repaglinide Krka

The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Krka to Krka, d.d., Novo mesto on 4 November 2009.

Repaglinide Krka : EPAR - Summary for the public

Product information

Repaglinide Krka : EPAR - Product Information

Repaglinide Krka : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Repaglinide Krka
• 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/001066
• 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:
  Krka, d.d., Novo mesto

  Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Opinion adopted:
  23/07/2009
• Marketing authorisation issued:
  03/11/2009
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

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

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

Initial marketing authorisation documents

Repaglinide Krka : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Repaglinide Krka