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 date:
2024-07-12
Description:
PRE-FILLED PEN
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Company:
BIOCON SDN.BHD
No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian Silc
Iskandar Puteri
Johor
Malaysia
79200
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Biosimilar Biologic Drug:
Yes
Anatomical Therapeutic Chemical (ATC ):
See footnote 4
A10AE04 INSULIN GLARGINE
List of active ingredient(s)
Active ingredient(s)
See footnote 8
Strength
INSULIN GLARGINE
100 UNIT / ML
A Risk Management Plan (RMP) for this product was submitted.
Footnotes
Footnote 1
The earliest marketed date recorded in the Drug Product Database.
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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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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 .
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