AusPAR: Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3)
Australian Public Assessment Report
Device/Product Name
Pandemrix H1N1 pandemic influenza vaccine
Active ingredients
Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3)
AusPAR Date
Published
Submission Number
PM-2010-02995-3-2
Submission Type
Major variation (change in patient group, dosing schedule)
Decision
Not approved: Proposed amendment to include dosage instructions for children aged 6 months to 17 years in the Product Information. Approved: Other revisions to the Product Information, including amendment of the Dosage section to state: "Individuals aged 20 years and older: One or two doses of 0.5ml"; and inclusion, under the Clinical Trials and Adverse Reactions sections, of data from clinical trials in those aged 6 months to 17 years.