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:
Marketed
Current status date:
2020-06-08
Original market date: See footnote 1
2020-06-08
Product name:
FRAGMIN
Description:
PREFILLED SYRINGES
DIN:
02494582
Product Monograph/Veterinary Labelling:
Date:
2022-12-29
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PFIZER CANADA ULC
17300 Trans-Canada Highway
Kirkland
Quebec
Canada
H9J 2M5
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous , Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
20:12.04.16
Anatomical Therapeutic Chemical (ATC): See footnote 4
B01AB04 DALTEPARIN
Active ingredient group (AIG) number:See footnote5
0126861002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DALTEPARIN SODIUM | 16500 UNIT / 0.66 ML |