off label indication
off label indication
use of a medication for a clinical purpose other than that approved by the FDA.
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In this article we report and analyze data on thalidomide dispensing, and prescription for approved and off label indications in Brasilia, DF, before (in 2001) and after (in 2011-12) the new regulation was enforced.
In 2011, federal health authority (Anvisa) issued new rules regarding thalidomide dispensing and clinical use that opened a door for drug dispensing for off label indications (22).
8% of all prescriptions) mask use for off label indications that were not recorded as such.
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