STN: BL 125158
Proper Name: Smallpox (Vaccinia) Vaccine, Live
Manufacturer: Sanofi Pasteur Biologics LLC
- Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
February 5, 2016 Approval Letter - ACAM2000(PDF - 41KB)
To change the package insert to include clarifying revisions to Section 5 and to reflect the removal of the requirement to have a risk evaluation and mitigation strategy (REMS)
- August 24, 2015 Risk Evaluation and Mitigation Strategy Release Letter - ACAM2000 (PDF - 35KB)
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.
ACAM2000 (Smallpox Vaccine) Questions and Answers FDA Online Label Repository
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