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:
Authorization By Interim Order Revoked
Current status date:
2021-11-19
Original market date: See footnote 1
Product name:
VAXZEVRIA
Description:
VIAL CONTAINS 8 DOSES OF 0.5ML
DIN:
02511444
Product Monograph/Veterinary Labelling:
Date:
2021-09-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ASTRAZENECA CANADA INC
1004 Middlegate Road, Suite 5000
Mississauga
Ontario
Canada
L4Y 1M4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
1
Schedule(s):
COVID-19 - IO - Authorization , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BN02 COVID-19, VIRAL VECTOR, NON-REPLICATING
Active ingredient group (AIG) number:See footnote5
0162722001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| CHADOX1-S [RECOMBINANT] | 50000000000 VP / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Registry |