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In this section: Vaccines

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

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

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