1. The use of a pharmaceutical drug or medical device for a purpose, population, or dosage other than what has been officially approved by regulatory authorities
The doctor prescribed an off-label treatment for the patient's rare condition because no approved medication existed.
O médico prescreveu um tratamento fora de bula para a condição rara do paciente porque nenhum medicamento aprovado existia.
2. Medical practice where drugs are used in ways not specified in their official labeling or package insert
Off-label treatment is common in pediatric medicine when standard drugs are adapted for children.
O tratamento fora de bula é comum em medicina pediátrica quando medicamentos padrão são adaptados para crianças.