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Sanofi Pasteur, Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Sanofi Pasteur Briefing Document (pdf)

 

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

Topic 1: Safety and Immunogenicity of H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (clade 1), 90µg/mL, Manufactured by Sanofi Pasteur (htm)

Errata: Topic 1: Safety & Immunogenicity of H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (clade 1), 90µg/mL, Manufactured by Sanofi Pasteur – Page 16 (htm)

Topic 1: Pharmacovigilance plan for an H5N1 Inactivated Influenza Vaccine Manufactured by Sanofi Pasteur (htm)

Topic 2: Clinical Development of Influenza Vaccines for Pre-pandemic Uses (htm)

Bibliography 1 (htm)

Bibliography 2 (htm)