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:
2021-08-30
Original market date: See footnote 1
2021-08-30
Product name:
VERITY-BCG
DIN:
02508613
Product Monograph/Veterinary Labelling:
Date:
2021-01-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VERITY PHARMACEUTICALS INC.
2560 Matheson Blvd. E., Suite 220
Mississauga
Ontario
Canada
L4W 4Y9
Class:
Human
Dosage form(s):
Powder For Suspension
Route(s) of administration:
Intravesical
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
Anatomical Therapeutic Chemical (ATC): See footnote 4
L03AX03 BCG VACCINE
Active ingredient group (AIG) number:See footnote5
0162601001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BACILLUS CALMETTE-GUÉRIN (BCG) - STRAIN RUSSIAN BCG-I | 40 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Education |
| Healthcare Professional Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |