STN: BL 103915
Proper Name: Yellow Fever Vaccine
Manufacturer: Sanofi Pasteur, Inc, License #1725
For active immunization of persons 9 months of age and older who:
- Are living in or traveling to endemic areas;
- Travelling internationally to countries that require evidence of vaccination from entering travelers or;
- Laboratory Personnel who might be expose to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain by direct or indirect contact or by aerosols should by vaccinated.
June 15, 2016 Approval Letter - YF-VAX(PDF - 28KB)
To revise the package insert to align Booster Dosing language with recent changes to International Health Regulations and WHO/ACIP recommendations, and to modify the text throughout the document to clarify and update the presented information.
April 6, 2016 Approval Letter - YF-VAX(PDF - 28KB)
To include changes to the product labeling.
December 19, 2013 Approval Letter - YF-Vax January 28, 2010 Approval Letter - YF Vax[ARCHIVED]
To include correct description of appearance of the vaccine after reconstitution with diluent, and to make other minor editorial changes in the package insert.
February 12, 2008 Approval Letter - YF-Vax
To include changes to the package insert for Contraindications, Precautions and Adverse Reactions.
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