Product information

From Health Canada

An Interim Order was issued by the Minister of Health at the request of the Public Health Agency of Canada to allow the authorization for sale of a vaccine for the novel Influenza A H1N1 virus in response to the influenza A H1N1 pandemic. An Interim Order is issued by the Minister of Health under Section 30.1 of the Food and Drugs Act in rare situations where the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to human health, public safety, or the environment. For more information, please refer to the following link: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-eng.php

Current status:

Cancelled Post Market

Current status date:

2010-09-13

Original market date: See footnote 1

2009-11-12

Product name:

INFLUENZA A (H1N1) 2009 PANDEMIC MONOVALENT VACCINE (WITHOUT ADJUVANT)

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DIN:

02337258

Product Monograph/Veterinary Labelling:

Date: 2010-07-22 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):

1

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

0152670001

List of active ingredient(s)
Active ingredient(s) Strength
HAEMAGGLUTININ FROM A/CALIFORNIA/7/2009 (H1N1)V-LIKE STRAIN (X-179A) 15 MCG / 0.5 ML
Version 4.0.2
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