STN: BL 103552
Proper Name: Varicella Virus Vaccine, Live
Manufacturer: Merck & Co, Inc
- For active immunization of persons 12 months of age and older.
- Optional second dose for children 12 months to 12 years of age.
March 28, 2014 Approval Letter - Varivax
To add the term “necrotizing retinitis (in immunocompromised individuals)” to section 6.2 of the US Prescribing Information (USPI).
September 12, 2013 Approval Letter - Varivax[ARCHIVED]
To revise package insert.
December 11, 2012 Approval Letter-Varivax[ARCHIVED]
To include revised labeling in Physician Labeling Rule (PLR) format submitted under section 351 of the Public Health Service Act (42 U.S.C. 262).
February 3, 2012 Approval Letter - Varivax[ARCHIVED]
Revise the Package Insert and the Patient Product Information sheet for the refrigerator-stable and frozen formulations to include “varicella (vaccine strain)”
September 29, 2011 Approval Letter - Varivax[ARCHIVED]
To extend the storage time for the Frozen Formulation from 3 days to 8 days when stored at 2°C to 8°C.
October 13, 2010 Approval Letter - Varivax[ARCHIVED]
Update: Package Insert and Patient Product Information sheets to include changes to the Adverse Reaction and Risk of Vaccine Transmission section
June 3, 2009 Approval Letter - Varivax[ARCHIVED]
To include use of a Patient Package Insert.
October 30, 2008 Approval Letter - Varivax[ARCHIVED]
To remove the phrase “(Oka/Merck)” from the generic name on the product carton and container labeling, and from the package insert.
April 5, 2005 Approval Letter - Varivax[ARCHIVED]
New Indication: Optional second dose for children 12 months to 12 years of age.
Review - Part 1 - Varivax(PDF - 1.7MB) March 17, 1995 Approval Letter - Varivax
Summary for Basis of Approval - Varivax(PDF - 1.5MB) Protocols - Varivax(PDF - 847KB) [ARCHIVED]
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