Starlix
Withdrawn
This medicine's authorisation has been withdrawn
nateglinide
MedicineHumanWithdrawn
- 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The European Public Assessment Report (EPAR) for Starlix is updated to indicate that the marketing authorisation is no longer valid.
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).
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 diabetesTherapeutic indication
Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
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