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:
2008-02-05
Original market date: See footnote 1
2004-01-30
Product name:
GADOVIST 1.0
DIN:
02241089
Product Monograph/Veterinary Labelling:
Date:
2024-06-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAYER INC
2920 Matheson Blvd East
Mississauga
Ontario
Canada
L4W 5R6
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
36:89.00* See footnote6
Anatomical Therapeutic Chemical (ATC): See footnote 4
V08CA09 GADOBUTROL
Active ingredient group (AIG) number:See footnote5
0138761002
| Active ingredient(s) | Strength |
|---|---|
| GADOBUTROL | 604.72 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Checklist |
| Healthcare Professional Education |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Drug Utilisation Study (DUS) |
| Observational Studies |