Starlix

Withdrawn

This medicine's authorisation has been withdrawn

nateglinide

Overview

On 29 April 2022, the European Commission withdrew the marketing authorisation for Starlix (nateglinide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Starlix was granted marketing authorisation in the EU on 03 April 2001 for treatment of type 2 diabetes. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2006. 

The European Public Assessment Report (EPAR) for Starlix is updated to indicate that the marketing authorisation is no longer valid.

Starlix : EPAR - Summary for the public

Product information

Starlix : EPAR - Product Information

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