The specific case of a named-patient Compassionate Use Programme

Compassionate use on a named-patient basis is another possibility for early access to a medicinal product

A named-patient prescription is delivered for only one named patient not taking part in biomedical research, under the responsibility of the prescribing physician, and when the medicinal product is likely to present a benefit for this patient.

These are medicinal products whose efficacy/safety ratio is supposed to be favourable considering the available data or, exceptionally, medicinal products prescribed because a fatal outcome for the patient in the near futture is unavoidable, given the current state of available therapies for the patient's condition.

Page created: 30/10/2013
Page last updated: 07/11/2014
 
 
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