STN: BL 125158
Proper Name: Smallpox (Vaccinia) Vaccine, Live
Manufacturer: Emergent Product Development Gaithersburg, Inc.
- Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
- May 2, 2017 Approval Letter - ACAM2000
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, Titled "Recommendation for Labeling Medical Products to Inform Users that the Products or Product Container is not made with Natural Rubber Latex."
- February 5, 2016 Approval Letter - ACAM2000
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
- Supporting Documents older than three years - ACAM2000