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List 648/96 - AIFA How to apply for inclusion of a drug/therapeutic indication not yet authorised by the SSN

In these times of the COVID-19 emergency, we often hear about the '648/96' list and reimbursed drugs for off-label use... but what does this mean?

Law 648 of 1996 introduced the possibility of using and prescribing drugs outside the therapeutic indications approved by AIFA, at the full expense of the National Health Service, in order to respond promptly to situations of therapeutic need, such as today for coronavirus (but not only).

In this factsheet we explain what 648 is for, when, who and how it can be applied for, and the procedure of the evaluation.

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