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STN: BL 125259
Proper Name: Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Manufacturer: GlaxoSmithKline Biologicals
- Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females 9 through 25 years of age
July 17, 2014 Summary Basis for Regulatory Action - CERVARIX(PDF - 91KB) July 21, 2014 Approval Letter - CERVARIX
To include efficacy and immunogenicity data from the end-of-study analyses of Study HPV-008 in the package insert and to update the pharmacovigilance plan.
November 5, 2013 Approval Letter - Cervarix[ARCHIVED]
Language in the package insert addressing the presence of natural rubber latex in the pre-filled syringe tip cap
March 8, 2013 Approval Letter -CERVARIX
To include changes to the package insert reflect the discontinuation of the vial presentations.
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[ARCHIVED] 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)
FDA Approves New Vaccine for Prevention of Cervical Cancer[ARCHIVED]
Press Release: October 16, 2009