PSURs try pharmacovigilance records designed to offer an evaluation of one’s risk-benefit equilibrium out-of a therapeutic device at outlined date issues once its authorisation.

The intention of the newest PSUR is to try to present a comprehensive and you will vital studies of one’s risk-work with balance of the tool, looking at brand new otherwise emerging cover advice about framework away from cumulative information on chance and you will benefits

EMA and you may national competent government determine information for the PSURs to choose in the event the there are the brand new risks recognized to own a treatment and you can/or if their chance-benefit harmony changed. 閱讀更多Submission requirements and you will Eu reference dates: the brand new EURD number