Starlix

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nateglinide

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 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 of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 11/06/2018

Authorisation details

Product details
Name
Starlix
Agency product number
EMEA/H/C/000335
Active substance
nateglinide
International non-proprietary name (INN) or common name
nateglinide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BX03
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
03/04/2001
Contact address

Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

08/05/2018 Starlix - EMEA/H/C/000335 - T/0034

Contents

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

Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.

Assessment history

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