FOI release

Freedom of Information request (FOI 22/966)

Published 17 January 2024

FOI 22/966

21st October 2022

Dear

Many thanks for your follow-up request for the reference “S6” from the non-clinical expert report for Sporanox 10mg/ml Oral Solution (PL 00242/0307).

We have searched both our electronic and paper archive for this information, but cannot locate this specific reference or a reference list for the non-clinical expert report. Although the reference will have been submitted as part of the original licensing application, we can only conclude that because of the length of time since this application was originally granted a marketing authorisation, this information has not been retained by the agency.

Best regards
The FOI Licensing Team