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:
2024-01-09
Product name:
VAXCHORA
DIN:
02538164
Product Monograph/Veterinary Labelling:
Date:
2024-01-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAVARIAN NORDIC AS
Philip Heymans Alle 3
Hellerup
--
Denmark
2900
Class:
Human
Dosage form(s):
Powder For Suspension
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07AE02 CHOLERA, LIVE ATTENUATED
Active ingredient group (AIG) number:See footnote5
0164701001
| Active ingredient(s) | Strength |
|---|---|
| VIBRIO CHOLERAE, STRAIN CVD 103-HGR, LIVE | 2000000000 UNIT / DOSE |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.