An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.
An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.
A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…
View definitionAdverse Device Effect that has resulted in any of the consequences characteristic of a Serious…
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