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

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HAEMAGGLUTININ FROM A/CALIFORNIA/7/2009 (H1N1)V-LIKE STRAIN (X-179A)

Available from:

ID BIOMEDICAL CORPORATION OF QUEBEC

ATC code:

J07BB02

INN (International Name):

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Dosage:

15MCG

Pharmaceutical form:

SUSPENSION

Composition:

HAEMAGGLUTININ FROM A/CALIFORNIA/7/2009 (H1N1)V-LIKE STRAIN (X-179A) 15MCG

Administration route:

INTRAMUSCULAR

Units in package:

5ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0152670001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-09-13

Summary of Product characteristics

CAPU02-PIL 2.2
1
PRODUCT INFORMATION LEAFLET
INFLUENZA A (H1N1) 2009 PANDEMIC MONOVALENT VACCINE (WITHOUT ADJUVANT)
PANDEMIC INFLUENZA VIRUS VACCINE
MONOVALENT, INACTIVATED SPLIT VIRION
PREPARED IN EGGS
Suspension for Injection
ATC Code J07BB02
GLAXOSMITHKLINE INC.
Date of Preparation:
7333 Mississauga Road N.
Mississauga, Ontario
L5N 6L4
Control number: 134074-628929
Date of Approval: July 22, 2010
_© 2009 GlaxoSmithKline Inc. All Rights Reserved _
Influenza A (H1N1) 2009 Pandemic
GlaxoSmithKline
Monovalent Vaccine (Without Adjuvant)
CAPU02-PIL 2.2
2
PRODUCT INFORMATION LEAFLET
INFLUENZA A (H1N1) 2009 PANDEMIC MONOVALENT VACCINE (WITHOUT ADJUVANT)
Pandemic Influenza Virus Vaccine
Monovalent, Inactivated Split-Virion,
Prepared in Eggs
VERSION 2 APPROVED JULY 22, 2010
HEALTH CANADA HAS AUTHORIZED THE SALE OF INFLUENZA A (H1N1) 2009
PANDEMIC
MONOVALENT VACCINE (WITHOUT ADJUVANT) UNDER THE PROVISION OF AN
INTERIM
ORDER (IO) ISSUED ON OCTOBER 13, 2009.
The authorization is based on the Health Canada
review of the available data on quality, safety and immunogenicity,
and given the pandemic
threat at the time of authorization and its risk to human health,
Health Canada considers that the
benefit/risk profile of the of
INFLUENZA A (H1N1) 2009 PANDEMIC MONOVALENT VACCINE
(WITHOUT ADJUVANT)
is favourable for active immunization against the 2009 pandemic H1N1
influenza strain.
This pandemic vaccine has been authorized based on data obtained with
seasonal trivalent
influenza vaccine, FLUVIRAL
®
and preliminary results with the pandemic unadjuvanted H1N1
vaccine manufactured by GSK in Dresden, Germany as well as preliminary
safety data from
studies with the Canadian manufactured vaccine.
_ _
This Product Information Leaflet is primarily based on the FLUVIRAL
®
Product Monograph
and limited clinical data available for the pandemic unadjuvanted H1N1
vaccine at the time of
authorisation.
More clinical data is being generated and the Product Information
Leaflet will be updated based
on additional data becoming available.
PLEA