ETASU prvky na uistenie bezpečného užívania liekov REMS (stratégia hodnotenia a znižovania rizika)
Scope note in English
Strategies required by the US Food and Drug Administration (FDA) Amendments Act of 2007 when a question exists as to whether the benefits of a drug outweigh its risks. These constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients.
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