on-label use
[ɑn ˈleɪbəl ˈjuːs]
nounpl: on-label uses
uso conforme a bula
1. The use of a medication or medical device in accordance with the indications, dosages, and directions approved by regulatory authorities such as the FDA
The patient's treatment with the medication was an on-label use, as it was prescribed according to the FDA-approved indications.
O tratamento do paciente com o medicamento foi um uso conforme a bula, pois foi prescrito de acordo com as indicações aprovadas pela ANVISA.
2. Medical practice that follows the drug manufacturer's approved specifications and recommendations as stated in the prescribing information
Doctors prefer on-label use whenever possible to ensure patient safety and liability protection.
Os médicos preferem o uso conforme a bula sempre que possível para garantir a segurança do paciente e proteção de responsabilidade.
On-label use is a critical concept in pharmaceutical regulation and medical practice. In Brazil, the ANVISA (Agência Nacional de Vigilância Sanitária) oversees drug approval and labeling, similar to the FDA in the United States. Healthcare providers prioritize on-label use for legal protection and patient safety. Off-label use, while legal under certain circumstances in both countries, requires special documentation and informed consent. This terminology is essential in medical, pharmaceutical, and legal discussions.
Related Idioms & Phrases
within the scope of the label
according to the prescribing information
as indicated on the package insert
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