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:
2011-08-15
Original market date: See footnote 1
2003-04-15
Product name:
DUKORAL
DIN:
02247208
Product Monograph/Veterinary Labelling:
Date:
2023-06-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VALNEVA SWEDEN AB
Gunnar Asplunds Allé 16
Stockholm
--
Sweden
10521
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Oral
Number of active ingredient(s):
5
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07AE01 CHOLERA, INACTIVATED, WHOLE CELL
Active ingredient group (AIG) number:See footnote5
0548981004
| Active ingredient(s) | Strength |
|---|---|
| RECOMBINANT CHOLERA TOXIN B SUBUNIT | 1 MG / DOSE |
| VIBRIO CHOLERAE INABA 48 CLASSICAL BIOTYPE, HEAT INACTIVATED | 31250000000 CELLS / DOSE |
| VIBRIO CHOLERAE INABA 6973 EL TOR BIOTYPE, FORMALIN INACTIVATED | 31250000000 CELLS / DOSE |
| VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, FORMALIN INACTIVATED | 31250000000 CELLS / DOSE |
| VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, HEAT INACTIVATED | 31250000000 CELLS / DOSE |