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:
2023-01-31
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 .
Company:
IMMUNEX CORPORATION
One Amgen Centre Drive
Thousand Oaks
California
United States
91320-1799
Dosage form(s):
Kit
,
Powder For Solution
,
Liquid
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
2
Schedule(s):
Schedule D
,
Prescription
Anatomical Therapeutic Chemical (ATC ):
See footnote 4
L04AB01 ETANERCEPT
List of active ingredient(s)
Active ingredient(s)
See footnote 8
Strength
ETANERCEPT
25 MG / KIT
WATER
1 ML / KIT
A Risk Management Plan (RMP) for this product was submitted.
Footnotes
Footnote 1
The earliest marketed date recorded in the Drug Product Database.
Return to footnote 1referrer
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.
Return to footnote 2referrer
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.
Return to footnote 3referrer
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.
Return to footnote 4referrer
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%.
Return to footnote 5referrer
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.
Return to footnote 7referrer
Footnote 8
An asterisk * preceding an active ingredient indicates that the name of the active ingredient has been shortened to fit inside the database's field and that the active ingredient's full name is available on the product's Product Monograph/Veterinary Labelling available above and/or in the NOTES section of the QRYM_ACTIVE_INGREDIENTS extract available in the Drug product database (DPD) data extracts. The following link provides an explanation of the ordering of the data values contained in the DPD data extracts Read me file .
Return to footnote 8referrer
