About
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 their 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 Enyglid?
Enyglid 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).
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 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. Enyglid 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 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 anti-diabetes medicine, the recommended starting dose is 1 mg.
Enyglid 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 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 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.
- Why has Enyglid been approved?
The Committee for Medicinal Products for Human Use (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 to Krka, d.d., Novo mesto on 14 October 2009.
This EPAR was last updated on 04/05/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
15/03/2011 Enyglid -EMEA/H/C/001065 -N/0003
| Name | Language | First published | Last updated |
|---|---|---|---|
| Enyglid : EPAR - Product Information | BG = bălgarski | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | ES = español | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | CS = čeština | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | DA = dansk | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | DE = Deutsch | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | ET = eesti keel | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | EL = elliniká | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | EN = English | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | FR = français | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | IT = italiano | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | LV = latviešu valoda | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | LT = lietuvių kalba | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | HU = magyar | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | MT = Malti | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | NL = Nederlands | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | PL = polski | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | PT = português | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | RO = română | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | SK = slovenčina | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | SL = slovenščina | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | FI = suomi | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | SV = svenska | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | IS = Islenska | 19/10/2009 | 04/05/2011 |
| Enyglid : EPAR - Product Information | NO = Norsk | 19/10/2009 | 04/05/2011 |
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Enyglid : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 04/05/2010 | 04/05/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Enyglid : EPAR - Public assessment report | (English only) | 19/10/2009 |
Authorised
This medicine is approved for use in the European Union
Enyglid RSS feedMore information on Enyglid
- Questions and answers on generic medicines (29/03/2011)