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repaglinide

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 28/09/2017

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
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

05/09/2017 NovoNorm - EMEA/H/C/000187 - N/0090

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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