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TECARTUS DIN 02516667

Status: Marketed
Holder: GILEAD SCIENCES CANADA INC
Molecule: BREXUCABTAGENE AUTOLEUCEL

Health Canada record

Active ingredient(s)BREXUCABTAGENE AUTOLEUCEL 200000000 CELLS
Dosage formSuspension
RouteIntravenous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCL01XL06 BREXUCABTAGENE AUTOLEUCEL
Original market date16-Dec-2021
Current status date16-Dec-2021
SourceHealth Canada DPD

Establishment licence of the holder

Gilead Sciences Canada Inc — licence 101221, currently licensed, last inspection rating C (2022-09-20).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing BREXUCABTAGENE AUTOLEUCEL

DINProductCompanyFormStrengthStatus
02532719TECARTUSGILEAD SCIENCES CANADA INCSuspensionBREXUCABTAGENE AUTOLEUCEL 100000000 CELLSMarketed

Notices of Compliance

NOCDateSubmissionReason
356482025-06-26Supplement to a New Drug Submission (SNDS)Labelling updates
260272021-06-08New Drug Submission (NDS)
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