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:

Dormant

Current status date:

2021-11-10

Original market date: See footnote 1

2015-09-23

Product name:

FLUVIRAL

Description:

TRIVALENT, SPLIT-VIRION, INACTIVATED INFLUENZA VACCINE

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DIN:

02420686

Product Monograph/Veterinary Labelling:

Date: 2021-09-24 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

J07BB02 INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Active ingredient group (AIG) number:See footnote5

0324197003

List of active ingredient(s)
Active ingredient(s) 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.

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