Product information

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:

Cancelled Post Market

Current status date:

2019-08-22

Original market date: ^{See footnote 1}

2006-08-16

Lot number: ^{See footnote 2}

M036460

Expiry date: ^{See footnote 2}

2019-03-31

Product name:

GARDASIL

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:

02283190

Product Monograph/Veterinary Labelling:

Date: 2015-03-10 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):

Schedule(s):

Schedule D

American Hospital Formulary Service (AHFS): ^{See footnote 3}

80:12.00

Anatomical Therapeutic Chemical (ATC): ^{See footnote 4}

J07BM01 PAPILLOMAVIRUS (HUMAN TYPES 6,11,16,18)

Active ingredient group (AIG) number:^{See footnote5}

0451650001

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	40 MCG / 0.5 ML
RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN	20 MCG / 0.5 ML
RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN	20 MCG / 0.5 ML

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Footnotes

Footnote 1

The earliest marketed date recorded in the Drug Product Database.

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Footnote 2

When a manufacturer decides to discontinue the sale of their drug, the date of discontinuation is the date of the last sale by the manufacturer. The DIN will be cancelled further to the receipt of a sale discontinuation notification from the manufacturer. The status of the DIN will be updated to “Cancelled (Post-Market)” in the online Drug Product Database. For DINs cancelled on or after March 14, 2017, the latest expiry date and lot number of the product distributed in Canada will be posted on the online Drug Product Database. Other parties in the health product distribution chain such as wholesalers, retailers, pharmacists and medical practitioners may still sell or distribute that drug after DIN cancellation if the expiry date of the drug lot has not passed. This may be acceptable so long as the DIN cancellation is not due to health and/or safety reasons.

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Footnote 3

The American Hospital Formulary Service permits an easy review of information on a group of drugs with similar activities and uses and allows the reader to determine quickly the similarities and differences among drugs within a group. AHFS® Pharmacologic/Therapeutic Classification© used with permission. © 2022, the American Society of Health-System Pharmacists, Inc. (ASHP). The Data is a part of the AHFS Drug Information®; ASHP is not responsible for the accuracy of transpositions from the original context.

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Footnote 4

The purpose of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system is to be used as a tool for drug utilization research in order to improve quality of drug use. Drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutical properties.

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Footnote 5

The AIG number is a 10 digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). The AIG is comprised of three portions:

the first portion (2 digits) identifies the number of active ingredients,
the second portion (5 digits) identifies the unique groups of active ingredients(s),
the last portion (3 digits) identifies the active ingredient group strength. The strength group has a tolerance of ‑2% to +10%.

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Date modified:: 2019-03-01