Regulatory & Pharmacy documents
Clinical trial approvals 17 Jan 2025 Approval documents can also be found on the CTIS website (trial number 2023-507441-29-00)
Summaries of product characteristics
Pharmacy documents
Pharmacy Briefing V2.1 (Nov 2025)
Baloxavir marboxil temperature excursion form
Baloxavir marboxil IMP labelling Full blister label
Baloxavir marboxil IMP labelling Full box label
Baloxavir marboxil packaging photographs
Baloxavir marboxil receipt and return handling instructions
Baloxavir marboxil accountability log
Archive of previous documents and changes
Protocol V27.0 (no longer in use)
EU RSA V1.0 (no longer in use)
EU Pharmacy briefing V1.0 (no longer in use)
Tracked word documents of protocol V28.0, EU RSA V2.0 and pharmacy briefing V2.1