STN: BL 125158
Proper Name: Smallpox (Vaccinia) Vaccine, Live
Manufacturer: Sanofi Pasteur Biologics Co., License No. 1815
- Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
May 5, 2010 Approval Letter - ACAM2000
Revisions: Change in the package insert, carton, vial, container and medication guide labeling for administrative changes and/or correction of inadvertent errors.
August 31, 2007 Approval Letter - ACAM2000
Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
FDA Approves Second-Generation Smallpox Vaccine[ARCHIVED]
Press Release: September 1, 2007
ACAM2000 (Smallpox Vaccine) Questions and Answers FDA Online Label Repository
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