VARIVAX (refrigerated and frozen formulations)

STN: BL 103552
Proper Name: Varicella Virus Vaccine Live
Tradename:VARIVAX
Manufacturer: Merck Sharp & Dohme LLC
Indication: 

• VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

Product Information

• Package Insert - Varivax (Frozen)
• Package Insert - Varivax (Refrigerator)
• Patient Information - Varivax (Refrigerator)
• Patient Information - Varivax (Frozen)

Supporting Documents

• August 21, 2023 Approval Letter - VARIVAX
• February 27, 2023 Approval Letter - VARIVAX
• February 27, 2023 Clinical Review Memo - VARIVAX
• Statistical Review - VARIVAX
• November 3, 2022 Approval Letter - VARIVAX (refrigerated and frozen formulations)
• September 15, 2020 Approval Letter - VARIVAX
• January 23, 2019 Approval Letter - VARIVAX
  To include an update to the package insert labeling regarding the storage condition for VARIVAX.
• October 19, 2018 Approval Letter - VARIVAX
• February 16, 2017 Summary Basis for Regulatory Action - VARIVAX
• February 17, 2017 Approval Letter - VARIVAX
• Supporting Documents older than three years - VARIVAX