UK launch is reported to have actually happened in Nov 21 (not Jul 21 as previously stated) .
UK price for 2 x 40mg film coated tablets = £100.00. Dose is 80mg as a single dose, taken within 2 days of onset of symptoms or 40mg as a single dose if patient weight <80kg .
Launched in the UK .
MHRA publishes SPC for baloxavir, which is licensed in the UK for treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in individuals aged 12 years and above. The SPC indicates approval actually happened in Jun 21, although information from the company previously indicated it happened in Jan 21 .
UK launch planned for July 2021 .
Approved in UK .
Licensed in EU (not UK) .
Recommended for EU approval by CHMP - the full indication is "for the treatment of uncomplicated influenza in patients aged 12 years and above. Also: for post-exposure prophylaxis of influenza in individuals aged 12 years and above." It should be used in accordance with official recommendations .
NDA is for indication ´treatment of influenza in patients aged 12 and above, including patients at high risk of developing influenza-related complications and for post-exposure prophylaxis of influenza in individuals aged 12´ .
The EMA have received a centralised marketing authorisation application for baloxavir. 
Uptake has been slow since launch in the US, partly due to its high cost, but also due to fears about resistance, with reports of ´mutant´ viral flu strains affecting efficacy of baloxavir in Japan .
EU filing planned for 2019 .
Approved in the US for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours 
Filed in US under priority review 
EU & US filings planned for 2018 .
Based on the results from CAPSTONE-1, a New Drug Application is planned in Japan later this year, as is a submission to US FDA .
Originated by Shionogi in Japan and licensed to Roche worldwide except Japan and Taiwan; Shionogi have it in PII trials in Japan and project a Japanese launch by Q1 2018 .