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PHESGO DIN 02512920

Status: Marketed
Holder: HOFFMANN-LA ROCHE LIMITED
Molecule: TRASTUZUMAB
Available to quote

Health Canada record

Active ingredient(s)TRASTUZUMAB 60 MG; PERTUZUMAB 60 MG
Dosage formSolution
RouteSubcutaneous
ScheduleSCHEDULE D; PRESCRIPTION
ClassHuman
ATCL01FY01 PERTUZUMAB AND TRASTUZUMAB
Original market date09-Apr-2021
Current status date09-Apr-2021
SourceHealth Canada DPD

Establishment licence of the holder

Hoffmann-La Roche Limited — licence 100006, currently licensed, last inspection rating C (2024-06-25).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing TRASTUZUMAB

DINProductCompanyFormStrengthStatus
02550989ADHEROZAACCORD HEALTHCARE INCPowder For Solution; KitTRASTUZUMAB 420 MGApproved
02550970ADHEROZAACCORD HEALTHCARE INCPowder For SolutionTRASTUZUMAB 150 MGApproved
02240692HERCEPTINHOFFMANN-LA ROCHE LIMITEDPowder For SolutionTRASTUZUMAB 440 MGMarketed
02480697HERCEPTIN SCHOFFMANN-LA ROCHE LIMITEDSolutionTRASTUZUMAB 600 MGMarketed
02480794HERZUMACELLTRION INC.Powder For Solution; KitTRASTUZUMAB 440 MGMarketed
02506211HERZUMACELLTRION INC.Powder For SolutionTRASTUZUMAB 150 MGMarketed
02496690KANJINTIAMGEN CANADA INCKit; Powder For SolutionTRASTUZUMAB 420 MGMarketed
02518244KANJINTIAMGEN CANADA INCPowder For SolutionTRASTUZUMAB 150 MGMarketed
02474425OGIVRIBIOSIMILAR COLLABORATIONS IRELAND LIMITEDPowder For SolutionTRASTUZUMAB 150 MGMarketed
02474433OGIVRIBIOSIMILAR COLLABORATIONS IRELAND LIMITEDPowder For SolutionTRASTUZUMAB 440 MG; WATER 20 MLMarketed
02524325ONTRUZANTSAMSUNG BIOEPIS CO., LTDPowder For SolutionTRASTUZUMAB 440 MGMarketed
02524317ONTRUZANTSAMSUNG BIOEPIS CO., LTDPowder For SolutionTRASTUZUMAB 150 MGMarketed
02512912PHESGOHOFFMANN-LA ROCHE LIMITEDSolutionTRASTUZUMAB 40 MG; PERTUZUMAB 80 MGMarketed
02483467TRAZIMERAPFIZER CANADA ULCPowder For SolutionTRASTUZUMAB 440 MGMarketed
02483475TRAZIMERAPFIZER CANADA ULCPowder For SolutionTRASTUZUMAB 150 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
253232021-03-01New Drug Submission (NDS)
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