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:
2020-09-25
Product name:
TYLENOL WITH CODEINE NO. 4
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Company:
JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada
M3C 1L9
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS ):
See footnote 3
28:08.92
,
28:08.08
Anatomical Therapeutic Chemical (ATC ):
See footnote 4
N02AJ06 CODEINE AND PARACETAMOL
List of active ingredient(s)
Active ingredient(s)
Strength
ACETAMINOPHEN
300 MG
CODEINE PHOSPHATE
60 MG
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
Additional Risk Minimization Measures
Healthcare Professional Education
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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Footnote 7
Refer to the Health Canada Guidance Documents - "Submission of Risk Management Plans and Follow-up Commitments" as well as "Submission of targeted Risk Management Plans Follow-up Commitments for Prescription Opioid-containing Products" for additional details.
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