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SPIKEVAX (elasomeran mRNA vaccine) Page 1 of 44 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION SPIKEVAX Elasomeran mRNA vaccine Dispersion for intramuscular injection Multidose Vial, mg / mL Multidose Vial, mg / mL Active Immunizing Agent ModernaTX, Inc. 200 Technology Square Cambridge, MA, USA, 02139 Imported and Distributed by: Innomar Strategies, Inc. 3470 Superior Ct, Oakville, ON L6L 0C4 Date of Initial Authorization: September 16, 2021 Date of Revision: July 14, 2022 Submission Control Number: 263775 SPIKEVAX (elasomeran mRNA vaccine) Page 2 of 44 RECENT MAJOR LABEL CHANGES 1. INDICATION July 2022 4. DOSAGE AND ADMINISTRATION July 2022 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING May 2022 7. WARNINGS AND PRECAUTIONS November 2021 8. ADVERSE REACTIONS July 2022 14. CLINICAL TRIALS, Study Results July 2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION SPIKEVAX™ Elasomeran mRNA vaccine Dispersion for intramuscular injection Multidose Vial, 100 mcg / 0.5mL Active Immunizing Agent Submission Control Number: 259289 ModernaTX, Inc. 200 Technology Square Cambridge, MA, USA, 02139 Imported and Distributed by: Innomar Strategies, Inc.
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