Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2015-03-18
Original market date: See footnote 1
2015-03-18
Product name:
GARDASIL 9
Description:
0.5ML SINGLE-DOSE VIALS AND PREFILLED SYRINGES
DIN:
02437058
Product Monograph/Veterinary Labelling:
Date:
2023-07-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada
H9H 4M7
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
9
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BM03 PAPILLOMAVIRUS (HUMAN TYPES 6,11,16,18,31,33,45,52,58)
Active ingredient group (AIG) number:See footnote5
0956550001
| Active ingredient(s) | Strength |
|---|---|
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN | 40 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN | 60 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN | 40 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN | 20 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN | 20 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN | 20 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN | 20 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN | 20 MCG / 0.5 ML |
| RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN | 30 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |