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:
2024-09-19
Original market date: See footnote 1
2023-12-08
Product name:
NUVAXOVID
Description:
MULTIDOSE VIAL (VIAL CONTAINS 5 DOSES OF 0.5ML)
DIN:
02543656
Product Monograph/Veterinary Labelling:
Date:
2024-09-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NOVAVAX INC.
700 Quince Orchard Road
Gaithersburg
Maryland
United States
20878
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intramuscular
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
J07BN04 COVID-19, PROTEIN SUBUNIT
Active ingredient group (AIG) number:See footnote5
0163400001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| SARS-COV-2 RECOMBINANT SPIKE PROTEIN | 5 MCG / 0.5 ML |