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Vaccines, Blood & Biologics
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Resources for You
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Varicella Virus Vaccine Live
Proper Name: Varicella Virus Vaccine Live
Tradename: Varivax
Manufacturer: Merck & Co, Inc, License #0002
Indication:
- Optional second dose for children 12 months to 12 years of age
- For active immunization of persons 12 months of age and older
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Product Information
- Label - Refrigerator-stable formulation - Varivax (PDF - 140KB)
October, 2008 - Label - Frozen - Varivax (PDF - 158KB)
October, 2008 - Patient Information about Varivax (Varicella Virus Vaccine Live) Frozen (PDF - 63KB)
- Patient Information about VARIVAX (Varicella Virus Vaccine) Refrigerator (PDF - 79KB)
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Supporting Documents
- June 3, 2009 Approval Letter
Revised: To include use of a Patient Package Insert. - October 30, 2008 Approval Letter - Varivax
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.... - April 5, 2005 Approval Letter - Varivax
Indication: Optional second dose for children 12 months to 12 years of age. - Review - Part 1 - Varivax (PDF - 1765KB)
- Review - Part 2 - Varivax (PDF - 813KB)
- March 17, 1995 Approval Letter - Varivax
Indication: For active immunization of persons 12 months of age and older. - Summary for Basis of Approval - Varivax (PDF - 1572KB)
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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