NovoNorm
repaglinide
Table of contents
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 of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
NovoNorm
|
Agency product number |
EMEA/H/C/000187
|
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novo Nordisk A/S
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
16/08/1998
|
Contact address |
Product information
05/09/2017 NovoNorm - EMEA/H/C/000187 - N/0090
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.