Product information
From Health Canada
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:
Approved
Current status date:
2023-05-11
Product name:
KIRSTY
Description:
MULTIDOSE VIAL
DIN:
02520982
Product Monograph/Veterinary Labelling:
Date:
2023-05-11
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BIOCON SDN.BHD
No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian Silc
Iskandar Puteri
Johor
Malaysia
79200
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Schedule D
Biosimilar Biologic Drug:
Yes
American Hospital Formulary Service (AHFS): See footnote 3
68:20.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
A10AB05 INSULIN ASPART
Active ingredient group (AIG) number:See footnote5
0144802001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| INSULIN ASPART | 100 UNIT / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.