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 females9 through 25 years of age
- April 25, 2016 Approval Letter - Cervarix
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
- February 13, 2015 Approval Letter - CERVARIX
- Approval History, Letters, Reviews, and Related Documents - Cervarix
- Supporting Documents older than three years - Cervarix