Table 1.

Definition of “off-label use” according to FDA, EMA, and AIFA.

Drug Regulatory Agency	Definition
FDA [4,5]	Off-label use is called “unlabeled indication” and is only referred to the physician who prescribes a certain drug to treat a patient for an unlabeled indication.
EMA [2,3]	Use of a medicine for an unapproved indication or in an unapproved age group, dosage or route of administration.
AIFA [1]	Treatment with a medicinal product regularly on the market but for a different indication from the one for which it was authorized, even in the presence of regularly authorized therapeutic alternatives.