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O que diz a Anvisa
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or National Science Foundation
doi: 10.1080/00365521.2017.1397736
But the specifics of this process - including how much time pharmacies have to exhaust existing inventory, whether existing patient prescriptions can continue to be filled, and how shortage status applies to specific dosage forms versus the drug as a whole - have been the subject of significant legal debate and litigation
& Hanafusa, T
[46] The data from the ASCEND study were also pooled with data from the two CAPACITY studies in a pre-specified analysis which showed that pirfenidone reduced the risk of death by almost 50% over one year of treatment
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