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Actelion Withdraws Its Application For An Extension Of Indication For Zavesca, Europe
The European Medicines Agency (EMEA) has been formally notified by
Actelion of its decision to withdraw its application for an extension of
indication for the centrally authorised medicine Zavesca (miglustat).
Zavesca was expected to be used for the treatment of neurological
manifestations in patients with Niemann Pick type C disease, a rare
inherited neurodegenerative disease of childhood and adolescence.
Zavesca is an orphan medicinal product.
Zavesca was first authorised in the European Union on 20 November 2002.
It is currently indicated for the oral treatment of mild to moderate
type 1 Gaucher disease. Zavesca may be used only in the treatment of
patients for whom enzyme replacement therapy is unsuitable.
The application for the extension of indication for Zavesca was
submitted to the EMEA on 16 October 2006. The Agency's Committee for
Medicinal Products for Human Use (CHMP) had given a negative opinion
recommending the refusal of the type II variation to extend the
indication on 18 October 2007. The company had requested a
re-examination of the negative opinion. The re-examination had not yet
finished when the company withdrew.
In its official letter, the company is saying that the withdrawal of the
application was based on its discussions with the CHMP regarding the
need for additional data to be provided from patients treated with
miglustat in the clinical setting. These data could be provided in order
to support a resubmission in this indication in the near future.
More information about Zavesca and the state of the scientific
assessment at the time of withdrawal will be made available in a
question-and-answer document. This document, together with the
withdrawal letter from the company, will be published on the EMEA
website in due course.
Notes:
1. Withdrawal of an application does not prejudice the possibility of a
company making a new application at a later stage.
2. More information about Zavesca is available in the European Public
Assessment Report (EPAR):
click here.
European Medicines Agency
Actelion cu retragerea cererii pentru o prelungire a indicaþie pentru Zavesca, Europa - Actelion Withdraws Its Application For An Extension Of Indication For Zavesca, Europe - articole medicale engleza - startsanatate