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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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02437058

Product Monograph/Veterinary Labelling:

Date: 2020-08-20 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  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:12.00   VACCINES

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 footnote 5

0956550001

List of active ingredient(s)
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

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