Product Information

• Package Insert & Patient Information- Cervarix (PDF - 289KB)

Supporting Documents

• July 16, 2012 Approval Letter - Cervarix
  Updated information regarding instruction on the method of vaccine administration in the Dosage and Administration section of the package insert.
• Summary Basis for Regulatory Action-Cervarix (PDF - 67KB)
• July 19, 2011 Approval Letter - Cervarix
  To include safety and immunogenicity data to support use in females as young as 9 years of age.
• Clinical Review of Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, Biologics License Application Efficacy Supplement , July 14, 2011 - Cervarix (PDF - 372KB)
• January 14, 2011 Approval Letter - Cervarix
  To revise the full prescribing information to reflect the data from the final re-analysis of HPV-008.
• January 13, 2011 Approval Letter - Cervarix
  To include a Patient Package Insert to the full prescribing information.
• November 23, 2010 Approval Letter - Cervarix
  To include that the prefilled syringe presentation with the tip cap may contain natural rubber latex
• September 2, 2010 Approval Letter - Cervarix
  To add lymphadenopathy to the Adverse Reactions, Postmarketing Experience section of the full prescribing information.
• May 5, 2010 Approval Letter - Cervarix
  Revise: To request that the pre-filled syringe cartons contain language stating that the tip cap and rubber plunger contain dry natural latex rubber.
• October 16, 2009 Approval Letter - Cervarix
• Summary Basis of Regulatory Action - Cervarix (PDF - 178KB)
• Summary Basis of Regulatory Action Errata - Cervarix
• Approval History, Letters, Reviews, and Related Documents - Cervarix
• Statistical Review and Evaluation - Cervarix (PDF - 87KB)
• APPENDIX 1: Primary and secondary immunogenicity objectives in study HAV-048 and respective results which did not provide support for approval of supplement are included in Appendix 1. (PDF - 145KB)

Related Information

• FDA Approves New Vaccine for Prevention of Cervical Cancer
  Press Release: October 16, 2009

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