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GARDASIL (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
GARDASIL
Date registered
Evaluation commenced
Decision date
Approval time
212 (255 working days)
Active ingredients
HPV Type 11 L1 Protein, HPV Type 16 L1 Protein, HPV Type 18 L1 Protein, HPV Type 31 L1 Protein, HPV Type 33 L1 Protein, HPV Type 45 L1 Protein, HPV Type 52 L1 Protein, HPV Type 58 L1 Protein, HPV Type 6 L1 Protein
Registration type
EOI
Indication
GARDASIL 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).
*Evidence of vaccine efficacy is based on the core efficacy population of females aged 16to 26 years. Immunogenicity studies have been conducted to link efficacy to youngerpopulations (females and males aged 9 to 15 years). Immunogenicity studies ofGARDASIL 9 have been conducted relating to females over 26 years of age (see section5.1 CLINICAL TRIALS for GARDASIL 9).
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration