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National Drug Formulary

GARDASIL 9 SUSPENSION FOR INJECTION [SIN15141P]

Active ingredients: HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN | HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN

View product's general information
Last updated on 9 October 2026

Product Info

GARDASIL 9 SUSPENSION FOR INJECTION

[SIN15141P]

Product information

Active Ingredient and Strength

HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - 40 MCG
HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - 60 MCG
HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - 40 MCG
HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - 20 MCG
HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - 20 MCG
HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - 20 MCG
HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - 20 MCG
HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - 20 MCG
HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - 30 MCG

Dosage Form

INJECTION, SUSPENSION

Manufacturer and Country

MERCK SHARP & DOHME LLC (BULK PRODUCTION & PRIMARY PACKAGER) - UNITED STATES
MSD INTERNATIONAL GMBH T/A MSD IRELAND (CARLOW) (BULK PRODUCTION & PRIMARY PACKAGER) - IRELAND

Registration Number

SIN15141P

Licence Holder

MSD PHARMA (SINGAPORE) PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07BM03

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

1. INDICATIONS AND USAGE

GARDASIL 9 is a vaccine indicated in girls and women from 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, and anal cancer; premalignant genital lesions (cervical, vulvar and vaginal); premalignant anal lesions; HPV infections; cervical adenocarcinoma in situ (AIS); and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is indicated in boys and men from 9 through 45 years of age for the prevention of premalignant lesions and HPV infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Dosing

2. DOSAGE AND ADMINISTRATION

2.1 General
Dosage
GARDASIL 9 should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule:

First dose: at elected date
Second dose: 2 months after the first dose
Third dose: 6 months after the first dose

Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 month after the first dose, and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

Alternatively, in individuals 9 through 14 years of age, GARDASIL 9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.

The use of GARDASIL 9 should be in accordance with official recommendations.

It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9.

The need for a booster dose has not been established. The duration of protection is currently unknown.

Method of Administration
GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

GARDASIL 9 must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.

2.2 Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL
Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for GARDASIL 9.

Safety and immunogenicity of GARDASIL 9 were assessed in individuals who previously completed a three-dose vaccination series with GARDASIL [See 8 ADVERSE REACTIONS and 10 CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Contraindications

4. CONTRAINDICATIONS

GARDASIL 9 is contraindicated in patients with hypersensitivity to either GARDASIL 9 or GARDASIL or any of the inactive ingredients in either vaccine.

Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL 9 or GARDASIL should not receive further doses of GARDASIL 9.