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City Swiftwater / / Company STATISTICAL Sanofi Pasteur Inc. / Sanofi Pasteur Inc. / / Country United States / Canada / / Event FDA Phase / / IndustryTerm trial protocol / prevention of influenza disease / / MedicalCondition sore throat / headaches / influenza disease / influenza-like illness / chills / laboratory-confirmed influenza / culture-confirmed influenza / cough / tiredness / inactivated influenza / influenza / wheezing / / MedicalTreatment active immunization / vaccination / / Organization Related Biological Products Advisory Committee / Approval Offices Signatory Authority / ADVISORY COMMITTEE / Vaccines and Related Biological Products Advisory Committee / / Person Wellington Sun / Goutam Sen / Vladimir Lugovtsev / Haiyan Qin / Sonny Saini / Edward W. Wolfgang / Sang Ahnn / Roshan Ramanathan / / Position Chair of the Review Committee / Director / DVRPA / Regulatory Project Manager / / Product Biologics / FIM12 / Fluzone / Fluzone HighDose vaccine / Fluzone HighDose / Influenza Vaccine Fluzone® / Fluzone Vaccine / Influenza Vaccine / influenza / / ProvinceOrState Pennsylvania / / Technology trial protocol / /
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Summary Basis for Regulatory Action Date: October 30, 2014 From: CDR Edward W. Wolfgang, MSA, Chair of the Review Committee BLA/ STN: [removed]Applicant Name: Sanofi Pasteur Inc. Date of Submission: December 30, 2013