STN: BL 125158
Proper Name: Smallpox and Mpox (Vaccinia) Vaccine, Live
Tradename: ACAM2000
Manufacturer: Emergent Product Development Gaithersburg Inc.
Indication:

• For active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection.

Product Information

• Package Insert - ACAM2000
• Medication Guide - ACAM2000

Supporting Documents

• August 29, 2024 Approval Letter - ACAM2000
• 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."
• August 24, 2015 Risk Evaluation and Mitigation Strategy Release Letter - ACAM2000
• Supporting Documents older than three years - ACAM2000

Related Information

• ACAM2000 (Smallpox Vaccine) Questions and Answers