Product Approval Information

Proper Name: Varicella Virus Vaccine Live
Tradename: Varivax
Manufacturer: Merck & Co, Inc, License #0002

Label - Refrigerator-stable formulation (PDF - 798 KB) - November, 2006
Label - Frozen (PDF - 709 KB) - November, 2006


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)

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)

 
Updated: April 5, 2007