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PRODUCT INFORMATION LEAFLET
AREPANRIX™ H1N1
AS03-Adjuvanted H1N1 Pandemic Influenza VaccineEmulsion for InjectionATC Code J07BB02GlaxoSmithKline Inc.7333 Mississauga RoadMississauga, OntarioL5N 6L4Date of Preparation:21 October 2009
©
2009 GlaxoSmithKline Inc. All Rights Reserved
™AREPANRIX H1N1 used under license by GlaxoSmithKline Inc.
CAPA01/PIL 1.0
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AREPANRIX™ H1N1 GlaxoSmithKline
PRODUCT INFORMATION LEAFLETArepanrix™ H1N1AS03-Adjuvanted H1N1 Pandemic Influenza VaccineVersion 1 approved October 21, 2009
Health Canada has authorized the sale of Arepanrix™ H1N1
based onlimited clinical testing in humans under the provision of an InterimOrder (IO) issued on October 13, 2009.
The authorization is based on the HealthCanada review of the available data on quality, safety and immunogenicity, and given thecurrent pandemic threat and its risk to human health, Health Canada considers that the benefit/risk profile of the Arepanrix
™
H1N1 vaccine is favourable for activeimmunization against the H1N1 2009 influenza strain in an officially declared pandemicsituation.As part of the authorization for sale for Arepanrix
™
H1N1, Health Canada has requestedthe sponsor agree to post-market commitments. Adherence to these commitments, as wellas updates to information on quality, non-clinical, and clinical data will be continuouslymonitored by Health Canada and the Public Health Agency of Canada.THIS LEAFLET WILL BE UPDATED ACCORDINGLY.PLEASE CONSULT THE HEALTH CANADA WEBSITE FOR THE MOST UP-TO-DATE INFORMATION FOR THIS PRODUCT:http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/index-fra.php RECOMMENDATIONS MADE BY THE PUBLIC H EALTH AGENCY OF CANADASHOULD ALSO BE TAKEN INTO CONSIDERATION.
CAPA01/PIL 1.0
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AREPANRIX™ H1N1 GlaxoSmithKline
TABLE OF CONTENTSPAGE
Adverse Reactions.....................................................................................................8
CAPA01/PIL 1.0
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