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PRODUCT MONOGRAPH

Page 1 of 27 PRODUCT MONOGRAPH DUKORAL Oral, Inactivated Cholera and ETEC Diarrhea Vaccine Oral Suspension Active Immunizing Agent for the Prevention of Diarrhea Caused by Vibrio cholerae and/or heat-labile toxin producing Enterotoxigenic Escherichia coli ATC Code: J07AE01 Manufactured by: Date of Approval: Valneva Sweden AB, 105 21 Stockholm, Sweden Imported by: Q&C Services 119-2550 Argentia Road Mississauga, Ontario, L5N 5R1 Distributed by: Valneva Canada Inc. 600-3535, Saint-Charles Blvd. Kirkland, Qu bec, H9H 5B9 December 22, 2015 Submission Control No. 188466 Page 2 of 27 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.

PRODUCT MONOGRAPH DUKORAL® Oral, Inactivated Cholera and ETEC Diarrhea Vaccine Oral Suspension Active Immunizing Agent for the Prevention of Diarrhea Caused by Vibrio cholerae and/or heat-labile toxin producing Enterotoxigenic Escherichia coli ATC Code: J07AE01 Manufactured by: Date of Approval: Valneva Sweden AB,

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