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Vaccines, Blood & Biologics
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Resources for You
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Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Proper Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Tradename: Gardasil
Manufacturer: Merck & Co., Inc, License #0002
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Gardasil
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Supporting Documents
- June 9, 2009 Approval Letter
- Reports of Health Concerns Following HPV Vaccination (CDC)
- Addressing Questions About Gardasil
- September 12, 2008 Approval Letter - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- Statistical Review and Evaluation - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- Clinical Review - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 2584KB)
- Appendix 1 - VIN 2/3 and VaIN 2/3 Lesions - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 156KB)
- Appendix 2 - AIS Lesions - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 52KB)
- Appendix 3 - CIN 2 AND CIN 3 Cases Associated with Non-Vaccine HPV Types - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 96KB)
- Information from CDC and FDA on the Safety of Gardasil Vaccine - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- June 12, 2008 Approval Letter - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- June 8, 2006 Approval Letter - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- Executive Summary - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 92KB)
- Gardasil (Human Papillomavirus Vaccine) Questions and Answers
- Clinical Review - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 4980KB)
- List of Tables - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 175KB)
- List of Figures - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 30KB)
- List of Appendices - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 262KB)
- Human Papillomavirus (HPV) Vaccine Safety
- FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus
- Fact sheet--HPV (human papillomavirus) (PDF) (PDF - 843KB)
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
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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