AusPAR: Human papillomavirus vaccine types 16 and 18 (recombinant AS04 adjuvanted)

Australian Public Assessment Report

AusPAR

AusPAR: Human papillomavirus vaccine types 16 and 18 (recombinant, AS04 adjuvanted) [PDF, 753.22 KB]

AusPAR: Human papillomavirus vaccine types 16 and 18 (recombinant, AS04 adjuvanted) [Word, 1.43 MB]

Attachment: Product Information: Human papillomavirus vaccine types 16 and 18 (recombinant, AS04 adjuvanted) [PDF, 546.55 KB]

Attachment: Product Information: Human papillomavirus vaccine types 16 and 18 (recombinant, AS04 adjuvanted) [Word, 636.86 KB]

Attachment: Extract from Clinical Evaluation Report: Human papillomavirus vaccine types 16 and 18 (recombinant, AS04 adjuvanted) [PDF, 1.73 MB]

Attachment: Extract from Clinical Evaluation Report: Human papillomavirus vaccine types 16 and 18 (recombinant, AS04 adjuvanted) [Word, 3.48 MB]

Device/Product Name

Cervarix

Active ingredients

Human papillomavirus vaccine types 16 and 18 (recombinant AS04 adjuvanted)

AusPAR Date

4 January 2016

Published

6 January 2016

Submission Number

PM-2014-01893-1-2

Submission Type

Major variation

Decision

Approved