Zostavax

STN: 125123
Proper Name: Zoster Vaccine, Live
Tradename: Zostavax
Manufacturer: Merck & Co., Inc
Indication: 

• For prevention of herpes zoster (shingles) in individuals 50 years of age and older.

Product Information

• Package Insert - Zostavax (Frozen)
• Package Insert - Zostavax (Refrigerator Stable)
• Patient Information - Zostavax (Frozen)
• Patient Information - Zostavax (Refrigerator Stable)

Supporting Documents

• February 21, 2019 Approval Letter - Zostavax
• January 23, 2019 Approval Letter - Zostavax
• April 18, 2018 Summary Basis for Regulatory Action - Zostavax
• April 19, 2018 Approval Letter - Zostavax
• March 21, 2018 Approval Letter - Zostavax
• August 3, 2017 Summary Basis for Regulatory Action - ZOSTAVAX
• August 3, 2017 Approval Letter - ZOSTAVAX
• March 15, 2017 Summary Basis for Regulatory Action - ZOSTAVAX
• March 15, 2017 Approval Letter - Zostavax
• Supporting Documents older than three years - ZOSTAVAX

Related Information

• FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles - ARCHIVED
• Zostavax (Herpes Zoster Vaccine) Questions and Answers