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SPIKEVAX DIN 02568365

Status: Approved
Holder: MODERNA BIOPHARMA CANADA CORPORATION
Molecule: *SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA

Health Canada record

Active ingredient(s)*SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 25 MCG
Dosage formDispersion
RouteIntramuscular
ScheduleSCHEDULE D
ClassHuman
ATCJ07BN01 COVID-19, RNA-BASED VACCINE
Original market date
Current status date18-May-2026
SourceHealth Canada DPD

Establishment licence of the holder

Moderna Biopharma Canada Corporation — licence 3-002801, currently licensed, last inspection rating C (2024-06-10).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing *SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA

DINProductCompanyFormStrengthStatus
02541270SPIKEVAXMODERNA BIOPHARMA CANADA CORPORATIONDispersion*SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 0.1 MGMarketed
02557770SPIKEVAXMODERNA BIOPHARMA CANADA CORPORATIONDispersion*SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA 50 MCGMarketed

Notices of Compliance

NOCDateSubmissionReason
375812026-05-18Supplement to a New Drug Submission (SNDS)New pre-filled syringe presentation. New drug product manufacturing site
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