Enyglid

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 Enyglid. 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 Enyglid.

What is Enyglid?

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

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

What is Enyglid used for?

Enyglid is used in adults who have type 2 diabetes. It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) is not adequately controlled by diet, weight reduction and exercise. Enyglid may also be used with metformin (another 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 Enyglid used?

Enyglid 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. Enyglid 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 diabetes medicine, the recommended starting dose is 1 mg.

How does Enyglid 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. Enyglid helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.

How has Enyglid been studied?

Because Enyglid is a generic medicine, studies in people 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 Enyglid?

Because Enyglid 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 Enyglid been approved?

The CHMP concluded that, in accordance with EU requirements, Enyglid 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 Enyglid be given marketing authorisation.

Other information about Enyglid

The European Commission granted a marketing authorisation valid throughout the European Union for Enyglid on 14 October 2009.

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

Enyglid : EPAR - Summary for the public

Product information

Enyglid : EPAR - Product Information

Enyglid : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Enyglid
• 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. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.

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/001065
• 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

• Marketing authorisation issued:
  13/10/2009
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Enyglid : EPAR - Procedural steps taken and scientific information after authorisation

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

Initial marketing authorisation documents

Enyglid : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Enyglid

Reference Number: EMEA/CHMP/441193/2009