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:
2017-09-15
Original market date: See footnote 1
2014-10-15
Product name:
FLUZONE QUADRIVALENT
Description:
0.5 ML PREFILLED SYRINGES. INFLUENZA VIRUS VACCINE QUADRIVALENT TYPES A & B (SPLIT VIRION)
DIN:
02420643
Product Monograph/Veterinary Labelling:
Date:
2024-04-23
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANOFI PASTEUR LIMITED
1755 Steeles Avenue West
Toronto
Ontario
Canada
M2R 3T4
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
4
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BB02 INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN
Active ingredient group (AIG) number:See footnote5
0455410001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| HAEMAGGLUTININ-STRAIN A (H1N1) | 15 MCG / 0.5 ML |
| HAEMAGGLUTININ-STRAIN A (H3N2) | 15 MCG / 0.5 ML |
| HAEMAGGLUTININ-STRAIN B (VICTORIA) | 15 MCG / 0.5 ML |
| HAEMAGGLUTININ-STRAIN B (YAMAGATA) | 15 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.