Starlix

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Withdrawn

This medicine's authorisation has been withdrawn

nateglinide
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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The European Public Assessment Report (EPAR) for Starlix is updated to indicate that the marketing authorisation is no longer valid.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

English (EN) (613.12 KB - PDF)

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български (BG) (787.46 KB - PDF)

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español (ES) (616.32 KB - PDF)

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čeština (CS) (767.27 KB - PDF)

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dansk (DA) (615.69 KB - PDF)

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Deutsch (DE) (617.69 KB - PDF)

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eesti (ET) (615.69 KB - PDF)

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ελληνικά (EL) (793.93 KB - PDF)

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français (FR) (617.14 KB - PDF)

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italiano (IT) (616.16 KB - PDF)

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latviešu (LV) (771.88 KB - PDF)

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lietuvių (LT) (732.44 KB - PDF)

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magyar (HU) (758.59 KB - PDF)

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Malti (MT) (769.36 KB - PDF)

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Nederlands (NL) (616.82 KB - PDF)

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polski (PL) (774.47 KB - PDF)

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português (PT) (617.04 KB - PDF)

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română (RO) (726.33 KB - PDF)

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slovenčina (SK) (763.18 KB - PDF)

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slovenščina (SL) (744.45 KB - PDF)

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suomi (FI) (616.11 KB - PDF)

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svenska (SV) (615.7 KB - PDF)

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Product information

Starlix : EPAR - Product Information

English (EN) (1.11 MB - PDF)

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български (BG) (2.05 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
Vizualizare

español (ES) (1.17 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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čeština (CS) (1.76 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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dansk (DA) (1.1 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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Deutsch (DE) (1.12 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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eesti (ET) (1.08 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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ελληνικά (EL) (2.1 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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français (FR) (1.22 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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hrvatski (HR) (1.22 MB - PDF)

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italiano (IT) (1.17 MB - PDF)

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latviešu (LV) (1.81 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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lietuvių (LT) (1.24 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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magyar (HU) (1.77 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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Malti (MT) (1.8 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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Nederlands (NL) (1.11 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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polski (PL) (1.76 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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português (PT) (1.13 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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română (RO) (1.23 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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slovenčina (SK) (1.77 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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slovenščina (SL) (1.72 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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suomi (FI) (1.09 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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svenska (SV) (1.23 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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Íslenska (IS) (1.09 MB - PDF)

Prima publicare: 07/12/2007 Cea mai recent: 28/06/2022
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norsk (NO) (1.15 MB - PDF)

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Latest procedure affecting product information:IB/0040
08/11/2021
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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

English (EN) (583.78 KB - PDF)

Prima publicare: Cea mai recent:
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български (BG) (674.04 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

español (ES) (584.08 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

čeština (CS) (629.08 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

dansk (DA) (578.44 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

Deutsch (DE) (583.5 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

ελληνικά (EL) (741.64 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

français (FR) (584.72 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

italiano (IT) (585.43 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

latviešu (LV) (669.3 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

lietuvių (LT) (654.3 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

magyar (HU) (666.1 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

Malti (MT) (664.54 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

Nederlands (NL) (584.28 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
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polski (PL) (630.62 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
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português (PT) (584.46 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

română (RO) (648.17 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
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slovenčina (SK) (629.5 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

slovenščina (SL) (618.03 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

suomi (FI) (584.58 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
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svenska (SV) (582.36 KB - PDF)

Prima publicare: 07/11/2007 Cea mai recent: 28/06/2022
Vizualizare

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

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

English (EN) (855.08 KB - PDF)

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

English (EN) (660.38 KB - PDF)

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Starlix : EPAR - Procedural steps taken before authorisation

English (EN) (665.79 KB - PDF)

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Starlix : EPAR - Scientific Discussion

English (EN) (995.19 KB - PDF)

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