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:
2020-08-26
Product name:
EPTIFIBATIDE INJECTION
Description:
FOR BOLUS INJECTION. 10ML SINGLE DOSE VIAL
DIN:
02422859
Product Monograph/Veterinary Labelling:
Date:
2020-08-25
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
STRIDES PHARMA CANADA INC
400 Applewood Crescent, Unit 100
Vaughan
Ontario
Canada
L4K 0C3
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
20:12.18
Anatomical Therapeutic Chemical (ATC): See footnote 4
B01AC16 EPTIFIBATIDE
Active ingredient group (AIG) number:See footnote5
0137621002
Active ingredient(s) See footnote8 | Strength |
---|---|
EPTIFIBATIDE | 2 MG / ML |