Abstract
Answer A. The use of a licensed medicine outside the terms of its marketing authorisation
Off-label use occurs when a licensed medicine is prescribed outside the conditions of its marketing authorisation, such as for a different age group, indication, dose or route. Unlicensed medicines (often called ‘specials’) have no marketing authorisation at all and are typically manufactured to meet specific patient needs. Off-label prescribing is common in paediatrics. Prescribers must ensure there is supporting evidence or accepted clinical practice, feel competent in prescribing the drug, and discuss rationale and risks with parents or carers.
InnovAiT article: Prescribing in children. DOI: 10.1177/17557380251400210.