Off Label Use as an Indicator of Therapeutic Need in Pediatrics

Unapproved use of an approved drug is called "off-label" use.In line with European Medicine Agency's pharmacovigilance directive, off-label use "relates to situations where a medicinal product is intentionally used for a medical purpose not in accordance with the authorised product information (SmPC) [1].This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat or more widely, not only for different indication but also for different route of administration, dosage, formulation, population from those approved by the Regulatory Agencies on the basis of data provided by the owner at the time of an application (benefit/risk ratio).