Product Information

• Package Insert - Varivax (Frozen) (PDF - 131KB)
• Package Insert - Varivax (Refrigerator) (PDF - 144KB)
• Patient Information - Varivax (Refrigerator) (PDF - 43KB)
• Patient Information - Varivax (Frozen) (PDF - 50KB)

Supporting Documents

• February 3, 2012 Approval Letter - Varivax
  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
  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
  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
  To include use of a Patient Package Insert.
• October 30, 2008 Approval Letter - Varivax
  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
  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
  Authorizes Merck
• Summary for Basis of Approval - Varivax (PDF - 1.5MB)
• Protocols - Varivax (PDF - 847KB)

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.

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