Product Dossier
CERVARIX
Product Dossier for CERVARIX (HPV Type 16 L1 Protein, HPV Type 18 L1 Protein, GlaxoSmithKline). ARTG record, PBS listing, PBAC outcomes, AusPAR —…
- Sponsor: GlaxoSmithKline
- Active ingredient: HPV Type 16 L1 Protein, HPV Type 18 L1 Protein
- Therapeutic area: Infectious Disease
- Related brand: GARDASIL
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Cervarix is a human papillomavirus vaccine containing types 16 and 18 (recombinant, AS04 adjuvanted) supplied as a suspension for injection in pre-filled syringes.
Approved indications
— Prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18 in females aged 10 to 45 years.
Key safety warnings
The vaccine has demonstrated statistically significant long-term efficacy against incident and persistent infections with HPV-16 and HPV-18, with cumulative vaccine efficacy over 6.4 years of 95.3% for incident infections and 98.2% for persistent infections.
Regulatory history
Cervarix was first listed on the ARTG on 18 May 2007. In March 2011, the TGA approved a major variation submission for Cervarix granting an extension of indications to females aged 10 to 45 years, based on updated clinical data demonstrating long-term vaccine efficacy against HPV-16 and HPV-18 related conditions. In November 2015, the PBAC recommended a change from a three-dose to a two-dose schedule for females aged 12 to less than 14 years.