AusPAR: Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3)
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Australian Public Assessment Report
14 March 2013
| AusPAR | |
|---|---|
| Active Ingredient | Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3)
|
| Product Name | Pandemrix H1N1 pandemic influenza vaccine
|
| Sponsor | GlaxoSmithKline Australia Pty Ltd
|
| 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.
|
| AusPAR Date | 12 February 2013
|
| Publication Date | 14 March 2013 |