Basic Information
A10BX02
repaglinide
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.
Overview Summary
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.
Active Substances (1)
repaglinide
Documents (9)
Enyglid : EPAR - Public assessment report
October 18, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Committee for medicinal products for human use summary of positive opinion for Enyglid
July 22, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Enyglid : EPAR - All Authorised presentations
October 9, 2009
AUTHORISED_PRESENTATIONS
Enyglid : EPAR - Procedural steps taken and scientific information after authorisation (archive)
May 3, 2010
CHANGES_SINCE_INITIAL_AUTHORISATION
Enyglid : EPAR - Public assessment report
October 18, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Committee for medicinal products for human use summary of positive opinion for Enyglid
July 22, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Enyglid : EPAR - Procedural steps taken and scientific information after authorisation
February 5, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Enyglid : EPAR - Summary for the public
October 18, 2009
OVERVIEW_DOCUMENT
Enyglid : EPAR - Product Information
October 18, 2009
DRUG_PRODUCT_INFORMATION
Overview Q&A (8)
Question
How does Enyglid work?
Answer
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.
Question
How is Enyglid used?
Answer
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.
Question
How has Enyglid been studied?
Answer
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.
Question
What are the benefit and risk of Enyglid?
Answer
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.
Question
Why has Enyglid been approved?
Answer
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.
Question
Other information about Enyglid
Answer
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.
Question
What is Enyglid?
Answer
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.
Question
What is Enyglid used for?
Answer
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.