labeled indication
[ˈleɪbəld ˌɪndɪˈkeɪʃən]
nounpl: labeled indications
indicação aprovada
1. A medical use or therapeutic purpose of a drug, device, or treatment that has been officially approved and documented by regulatory authorities, explicitly stated on the product labeling or package insert
The labeled indication for this antibiotic includes treatment of bacterial pneumonia and urinary tract infections.
A indicação aprovada para este antibiótico inclui o tratamento de pneumonia bacteriana e infecções do trato urinário.
2. The approved clinical uses that appear on the official drug label submitted to and approved by regulatory agencies such as the FDA
Physicians should prescribe medication only within its labeled indications unless they have clinical justification for off-label use.
Os médicos devem prescrever medicamentos apenas dentro de suas indicações aprovadas, a menos que tenham justificativa clínica para uso off-label.
This term is primarily used in pharmaceutical, medical, and regulatory contexts in both the United States and Brazil. In the USA, it is a critical legal and clinical term used by the FDA and healthcare professionals to distinguish between approved uses (on-label) and unapproved uses (off-label). In Brazil, healthcare providers must adhere to indicações aprovadas as determined by ANVISA (Agência Nacional de Vigilância Sanitária). Understanding labeled indications is essential for proper prescribing practices and liability protection.
Related Idioms & Phrases
within labeled indications
per labeled indication
according to labeled indications
uses not listed in labeled indications
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