Product Approval Information
Proper Name: Influenza Virus Vaccine
Tradename: AFLURIA
Manufacturer: CSL Limited, License No. 1764
STN: 125254/0
Approval Date: September 28, 2007
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Approval information/letter/labeling
Memorandum/Reviews
- Midpoint Management Meeting Memorandum
- Review of Chemical Analytical Procedures
- Statistical Review
- Summary of Bioresearch Monitoring Inspections
- Committee Meeting Memorandum
- CMC Review
- Statistical Review and Evaluation
- Clinical Review (PDF - 2.3 MB)
- BLA Review Memo: Mycoplasma Testing
- Chair Memo
Administrative Documents
Correspondence