Transcription of ENGERIX-B
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ENGERIX-B
product MONOGRAPH. including PATIENT medication information . ENGERIX-B . Hepatitis B vaccine (recombinant). mL and mL suspensions of 20 mcg/mL hepatitis B surface antigen for injection Active immunizing agent against infection caused by all known subtypes of hepatitis B virus ATC Code: J07BC01. GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4. Date of Initial Approval: November 06, 1987. Date of Revision: April 3, 2019. Submission Control No: 219320.. 2019 GSK group of companies or its licensor Trademarks are owned by or licensed to the GSK group of companies Page 1 of 27. RECENT MAJOR LABEL CHANGES. Warnings and Precautions, Immune (7) 10/2015. Clinical Trials, Special Populations and Conditions ( ) 10/2015. Dosage and Administration, Administration ( ) 08/2018. Dosage and Administration, Administration ( ) 04/2019. TABLE OF CONTENTS. RECENT MAJOR LABEL CHANGES ..2. TABLE OF CONTENTS ..2. PART I: HEALTH PROFESSIONAL information .
PRODUCT MONOGRAPH 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 all known subtypes of hepatitis B virus ATC Code: J07BC01 GlaxoSmithKline Inc. 7333 Mississauga Road
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