Product Approval Information
Proper Name: Varicella Virus Vaccine Live
Tradename: Varivax
Manufacturer: Merck & Co, Inc, License #0002
Label - Refrigerator-stable formulation (PDF - 140 KB) - October, 2008
Label - Frozen (PDF - 158 KB) - October, 2008
Date: October 30, 2008
Changes to the package insert: To remove the phrase “(Oka/Merck)” from the generic name on the product carton and container labeling and from within the package insert. In addition revisions to the package insert to clarify the statement regarding anaphylaxis.
October 30, 2008 Approval Letter
Date: April 5, 2005
Indication: Optional second dose for children 12 months to 12 years of age
April 5, 2005 Approval Letter
Review - Part 1 (PDF - 1.7 MB),
Review - Part 2 (PDF - 813 KB)
Date: March 17, 1995
Indication: For active immunization of persons 12 months of age and older
March 17, 1995 Approval Letter
Summary for Basis of Approval (PDF - 1.5 MB)