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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.
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. 3470 Superior Ct,
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