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:
2021-09-16
Product name:
VAL-ZOLEDRONIC ACID
Description:
PREFILLED SYRINGE
DIN:
02426412
Product Monograph/Veterinary Labelling:
Date:
2021-09-14
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAUSCH HEALTH, CANADA INC.
2150 Boul. St-Elzear Ouest
Laval
Quebec
Canada
H7L 4A8
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
92:24.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
M05BA08 ZOLEDRONIC ACID
Active ingredient group (AIG) number:See footnote5
0141761002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ZOLEDRONIC ACID (ZOLEDRONIC ACID HEMIPENTAHYDRATE) | 4 MG / 5 ML |