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Summary Basis of Regulatory Action Errata - Cervarix

From:    Robin Levis, Ph.D., Chair of the Review Committee
Through:  Jerry Weir, Ph.D., Director, Division of Viral Products
BLA/STN:  125259/0
Applicant Name: GlaxoSmithKline Biologicals (GSK)
Proprietary Name:  CERVARIX
Established Name:  Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Indication:

CERVARIX is indicated for use in females 10 through 25 years of age, for the prevention of the following diseases caused by Human Papillomavirus (HPV) types 16 and 18:

  • Cervical cancer
  • Cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 1

Statement of Errata: 
The following errors are noted on pages 7 and 8 of the October 15, 2009 version of the Summary Basis of Regulatory Action:

1) On page 7, the first paragraph, first sentence of section c), it is stated that two inspections were held to support the review and licensure of this product.

2) On page 7, the third paragraph, first sentence of section c), it is stated that a "second inspection was held at GSK Biologicals, North America, in Hamilton, Montana."

3) Page 8, third line, states that "All items were appropriately addressed and the compliance status of this site is deemed acceptable for product approval."

Only the Wavre, Belgium, facility inspection was conducted as a pre-approval inspection. The MPL facility located in Hamilton, Montana, was visited by CBER Reviewers to better understand the manufacturing process of the MPL component of this product.