Suspected Unexpected Serious Adverse Reaction

What is Suspected Unexpected Serious Adverse Reaction?

Suspected Unexpected Serious Adverse Reaction definition and meaning on Health terms:
A Suspected Unexpected Serious Adverse Reaction (SUSAR), is a serious adverse reaction (SAR) for which a reasonable causal relationship with the medicine use is suspected but not confirmed. Unexpected in this context means not consistent with the applicable product information (e. g. investigator’s brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product).

 

reference: https://www.eupati.eu/glossary/

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