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Health Canada Health products

Distribution of a New Presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) with English-only Vial and Carton Labels

Issued June 6, 2022
Issue
A new presentation of SPIKEVAX (elasomeran) with a concentration of 0.1 0 mg/mL in a 2.5 mL multidose vial was authorized on June 01, 2022. In order to provide rapid access to the new presentation of SPIKEVAX (0.1 0 mg/mL, 2.5 mL multidose vial), Moderna will distribute vaccine product with English-only carton and vial labels for a period of time. As a result, important Canadian-specific information is absent from these labels (see the Information for healthcare professionals section).
Hazard description
Labelling - Packaging - Product safety - COVID
Product
Product name
SPIKEVAX (elasomeran) (0.10 mg/mL)
Reference
ID
RA-64229