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Page 1 of 27 PRODUCT MONOGRAPHINCLUDING PATIENT MEDICATION INFORMATIONENGERIX-BHepatitis B vaccine (recombinant) mL and mL suspensions of 20 mcg/mL hepatitis B surface antigen for injectionActive immunizing agent against infectioncaused by allknown subtypes of hepatitis B virusATC Code: J07BC01 GlaxoSmithKline Mississauga RoadMississauga, OntarioL5N of Initial Approval:November06, 1987 Date of Revision:October 09, 2020 Submission Control No: 241268 2020 GSK group of companies or its licensorTrademarks are owned by or licensed to the GSK group of companies Page 2 of 27 RECENT MAJOR LABEL CHANGESW arnings and Precautions, Immune(7) 10/2015 Clinical Trials, Special Populations and Conditions( ) 10/2015 Dosage and Administration, Administration ( ) 04/2019 TABLE OF CONTENTSRECENT MAJOR LABEL OF CONTENTS.
INCLUDING PATIENT MEDICATION INFORMATION ENGERIX-B Hepatitis B vaccine (recombinant) 0.5 mL and 1.0 mL suspensions of 20 mcg/mL hepatitis B surface antigen for injection Active immunizing agent against infection caused by allknown subtypes of hepatitis B virus ATC Code: J07BC01 GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario …
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