Expectedness

An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described in the safety section of the product information. The local country label is used for determination of expectedness for Marketed Products used within the approved usage, and the Investigator Brochure (IB) is used for Investigational Products. Products used or assembled (formulated or packaged) in a different way from already marketed products or when used to gain further information about the authorized form, are considered Investigational Products. Adverse Events not described in the product information indicated above, or differing in nature, or of greater severity, are considered “unexpected”. In cases where it is unclear whether or not a reported event is expected, the event will be considered unexpected.