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:
Cancelled Post Market
Current status date:
2015-09-23
Original market date: See footnote 1
1993-12-31
Product name:
FLUVIRAL
DIN:
02015986
Product Monograph/Veterinary Labelling:
Date:
2019-04-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ID BIOMEDICAL CORPORATION OF QUEBEC
2323 Boul Parc Technologique
Quebec
Quebec
Canada
G1P 4R8
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
3
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BB01 INFLUENZA, INACTIVATED, WHOLE VIRUS
Active ingredient group (AIG) number:See footnote5
0324197001
| 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 | 15 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.