Starlix

Withdrawn

This medicine's authorisation has been withdrawn

nateglinide

Overview

The marketing authorisation for Starlix has been withdrawn at the request of the marketing-authorisation holder.

Starlix : EPAR - Summary for the public

Product information

Starlix : EPAR - Product Information

Latest procedure affecting product information: IB/0040

08/11/2021

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

Starlix : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Starlix
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000335
• Marketing authorisation holder:
  Novartis Europharm Limited

  Vista Building; Elm Park, Merrion Road; Dublin 4; Ireland

• Marketing authorisation issued:
  03/04/2001
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Starlix : EPAR - Procedural steps taken and scientific information after authorisation

Starlix : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Starlix : EPAR - Procedural steps taken before authorisation

Starlix : EPAR - Scientific Discussion