Gates Package — page 24

New Drug Application Approval favipiravir in Japan AVIGAN® Tablet 200mg ¢ March 24, 2014 ¢ Indications -- Novel or re-emerging influenza virus infections (limited to cases in which other anti-influenza virus agents are not effective or insufficiently effective) * Contraindications -- Women known or suspected to be pregnant ¢ Dosage and Administration (for adults in Japan) -- 1600 mg orally twice for 1 day followed by 600 mg orally twice daily for 4 days. The total administration period is five days. AVIGAN® is a drug the use of which is considered only when there is an outbreak of novel or re-emerging influenza virus infections in which other anti-influenza virus agents are not effective or insufficiently effective, and the government decides to use the drug as a countermeasure against such influenza viruses. It is manufactured upon request by the Minister of Health, Labor, and Welfare. =