Trazec
Lapsed
This medicine's authorisation has lapsed
nateglinide
MedicineHumanLapsed
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 3 April 2001, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Trazec (nateglinide), indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Trazec (nateglinide) had not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation, calculated from the entry into force of the Regulation (20 November 2005) for products authorised before this date.
Because of this, from 20 November 2008, the marketing authorisation for Trazec is no longer valid. Starlix (nateglinide) is an identical product authorised in the EU.
Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Trazec is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0017
23/07/2007
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
- Trazec
- 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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