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PYZCHIVA DIN 02550539

Status: Marketed
Holder: SAMSUNG BIOEPIS CO., LTD
Molecule: USTEKINUMAB

Health Canada record

Active ingredient(s)USTEKINUMAB 45 MG
Dosage formSolution
RouteSubcutaneous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCL04AC05 USTEKINUMAB
Original market date14-Jul-2026
Current status date14-Jul-2026
SourceHealth Canada DPD

Establishment licence of the holder

Samsung Bioepis Co., Ltd. — licence , not currently licensed, last inspection rating C (2023-04-03).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing USTEKINUMAB

DINProductCompanyFormStrengthStatus
02537257FINLIUSJANSSEN INCSolutionUSTEKINUMAB 90 MGMarketed
02537303FINLIUSJANSSEN INCSolutionUSTEKINUMAB 45 MGMarketed
02537311FINLIUS I.V.JANSSEN INCSolutionUSTEKINUMAB 5 MGMarketed
02564904IMULDOSAACCORD HEALTHCARE INCSolutionUSTEKINUMAB 90 MGApproved
02564890IMULDOSAACCORD HEALTHCARE INCSolutionUSTEKINUMAB 45 MGApproved
02564882IMULDOSA IVACCORD HEALTHCARE INCSolutionUSTEKINUMAB 5 MGApproved
02543036JAMTEKIJAMP PHARMA CORPORATIONSolutionUSTEKINUMAB 45 MGMarketed
02543044JAMTEKIJAMP PHARMA CORPORATIONSolutionUSTEKINUMAB 90 MGMarketed
02553120JAMTEKI I.V.JAMP PHARMA CORPORATIONSolutionUSTEKINUMAB 5 MGMarketed
02554291OTULFIFRESENIUS KABI CANADA LTDSolutionUSTEKINUMAB 90 MGMarketed
02554283OTULFIFRESENIUS KABI CANADA LTDSolutionUSTEKINUMAB 45 MGMarketed
02565420OTULFIFRESENIUS KABI CANADA LTDSolutionUSTEKINUMAB 45 MGApproved
02554305OTULFI I.V.FRESENIUS KABI CANADA LTDSolutionUSTEKINUMAB 5 MGMarketed
02562995PYZCHIVASAMSUNG BIOEPIS CO., LTDSolutionUSTEKINUMAB 45 MGApproved
02562987PYZCHIVASAMSUNG BIOEPIS CO., LTDSolutionUSTEKINUMAB 45 MGApproved
02550547PYZCHIVASAMSUNG BIOEPIS CO., LTDSolutionUSTEKINUMAB 90 MGMarketed
02563002PYZCHIVASAMSUNG BIOEPIS CO., LTDSolutionUSTEKINUMAB 90 MGApproved
02550520PYZCHIVA I.V.SAMSUNG BIOEPIS CO., LTDSolutionUSTEKINUMAB 5 MGMarketed
02320673STELARAJANSSEN INCSolutionUSTEKINUMAB 45 MGMarketed
02320681STELARAJANSSEN INCSolutionUSTEKINUMAB 90 MGMarketed
02459671STELARA I.V.JANSSEN INCSolutionUSTEKINUMAB 5 MGMarketed
02558270STEQEYMACELLTRION INC.SolutionUSTEKINUMAB 45 MGApproved
02550245STEQEYMACELLTRION INC.SolutionUSTEKINUMAB 45 MGMarketed
02566532STEQEYMACELLTRION INC.SolutionUSTEKINUMAB 45 MGApproved
02566540STEQEYMACELLTRION INC.SolutionUSTEKINUMAB 90 MGApproved
02550253STEQEYMACELLTRION INC.SolutionUSTEKINUMAB 90 MGMarketed
02550261STEQEYMA IVCELLTRION INC.SolutionUSTEKINUMAB 5 MGMarketed
02553317WEZLANAAMGEN CANADA INCSolutionUSTEKINUMAB 45 MGMarketed
02553309WEZLANAAMGEN CANADA INCSolutionUSTEKINUMAB 90 MGMarketed
02544199WEZLANAAMGEN CANADA INCSolutionUSTEKINUMAB 90 MGMarketed
02544180WEZLANAAMGEN CANADA INCSolutionUSTEKINUMAB 45 MGMarketed
02544202WEZLANAAMGEN CANADA INCSolutionUSTEKINUMAB 45 MGMarketed
02544210WEZLANA I.V.AMGEN CANADA INCSolutionUSTEKINUMAB 5 MGMarketed
02562103YESINTEKBIOCON BIOLOGICS CANADA INCSolutionUSTEKINUMAB 90 MGMarketed
02566478YESINTEKBIOCON BIOLOGICS CANADA INCSolutionUSTEKINUMAB 45 MGApproved
02569841YESINTEKBIOCON BIOLOGICS CANADA INCSolutionUSTEKINUMAB 90 MGApproved
02562081YESINTEKBIOCON BIOLOGICS CANADA INCSolutionUSTEKINUMAB 45 MGMarketed
02569833YESINTEKBIOCON BIOLOGICS CANADA INCSolutionUSTEKINUMAB 45 MGApproved
02562111YESINTEK I.V.BIOCON BIOLOGICS CANADA INCSolutionUSTEKINUMAB 5 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
337752024-08-07New Drug Submission (NDS)
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