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Cervarix / Human papillomavirus / Cervical cancer / HPV vaccine / Vaginal intraepithelial neoplasia / Cervical intraepithelial neoplasia / AS04 / Vaccine / Vulvar intraepithelial neoplasia / Papillomavirus / Medicine / Biology


T[removed]: Summary Basis of Regulatory Action (SBRA) Template
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City

Havrix / /

Company

GlaxoSmithKline Biologicals / Case / Chemistry Manufacturing / Controls No / Glaxosmithkline plc / /

Continent

Asia / North America / Europe / South America / /

Country

United States / /

Event

FDA Phase / Labor Issues / /

IndustryTerm

manufacturing / /

MedicalCondition

infertility / hepatitis A / cancer / disease / HPV / missed abortion / cervical cancer / preterm birth / chronic / Erythema / cervical intraepithelial neoplasia / diseases / CIN / infection / inflammation / spontaneous abortion / infections / appendicitis / autoimmune diseases / adenocarcinoma / /

MedicalTreatment

vaccinations / vaccination / /

Organization

Offices Signatory Authority / office of Vaccine Research / BLA STN / GlaxoSmithKline Biologicals’ HPV / Division of Vaccines and Related Products Applications / /

Person

Adamma Mba-Jonas / Wellington Sun / Nancy B. Miller / Helen S. Gemignani / Stephanie Polo / /

Position

Director / Project Manager / Chair of the Review Committee / /

Product

sodium chloride / this / STN / BLA / Efficacy / BLA Efficacy Supplement / /

Technology

laser / /

SocialTag