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:
2019-06-06
Original market date: See footnote 1
2019-06-06
Product name:
FLUOROURACIL INJECTION
Description:
PHARMACY BULK VIAL
DIN:
02473771
Product Monograph/Veterinary Labelling:
Date:
2024-09-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BIOLYSE PHARMA CORPORATION
59 Welland Vale Road
St. Catharines
Ontario
Canada
L2S 3Y2
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
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01BC02 FLUOROURACIL
Active ingredient group (AIG) number:See footnote5
0107505004
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| FLUOROURACIL | 5 G / 100 ML |