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SPIKEVAX BIVALENT (ORIGINAL / OMICRON BA.4/5) DIN 02532352

Status: Cancelled Post Market
Holder: MODERNA BIOPHARMA CANADA CORPORATION
Molecule: ELASOMERAN

Health Canada record

Active ingredient(s)ELASOMERAN 0.05 MG; DAVESOMERAN 0.05 MG
Dosage formDispersion
RouteIntramuscular
ScheduleSCHEDULE D
ClassHuman
ATCJ07BN01 COVID-19, RNA-BASED VACCINE
Original market date25-Nov-2022
Current status date19-Jan-2024
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 ELASOMERAN

DINProductCompanyFormStrengthStatus
02510014SPIKEVAXMODERNA BIOPHARMA CANADA CORPORATIONDispersionELASOMERAN 0.2 MGCancelled Post Market
02527685SPIKEVAXMODERNA BIOPHARMA CANADA CORPORATIONDispersionELASOMERAN 0.1 MGCancelled Post Market
02530252SPIKEVAX BIVALENTMODERNA BIOPHARMA CANADA CORPORATIONDispersionELASOMERAN 0.05 MG; IMELASOMERAN 0.05 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
317842023-10-04New Drug Submission (NDS)Administrative ¿ Change in Product Ownership
293692022-11-03New Drug Submission (NDS)
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