Periodic safety update report (PSUR) is an update of the worldwide safety experience of a medicinal product submitted to competent authorities at defined times post authorization. The marketing authorization holders (MAHs) must prepare PSURs and make them available to the regulatory authority.

> Worldwide marketing authorization status
> Overview of exposure and safety data
> Actions taken in the reporting interval for safety reasons
> Changes to reference safety information
> Estimated exposure and use patterns
> Summaries of significant findings from clinical trials in the reporting interval
> Findings from non-interventional studies
> Information from other clinical trials and sources
> Non-clinical data
> Literature
> Discussion and conclusions on PSUR data