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PEMAZYRE DIN 02519933

Status: Marketed
Holder: INCYTE CORPORATION
Molecule: PEMIGATINIB
Available to quote

Health Canada record

Active ingredient(s)PEMIGATINIB 4.5 MG
Dosage formTablet
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCL01EN02 PEMIGATINIB
Original market date06-Jan-2022
Current status date06-Jan-2022
SourceHealth Canada DPD

Establishment licence of the holder

Incyte Biosciences Technical Operations S.a.r.l. — licence , not currently licensed, last inspection rating C (2024-07-26).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing PEMIGATINIB

DINProductCompanyFormStrengthStatus
02519941PEMAZYREINCYTE CORPORATIONTabletPEMIGATINIB 9 MGMarketed
02519968PEMAZYREINCYTE CORPORATIONTabletPEMIGATINIB 13.5 MGMarketed

Notices of Compliance

NOCDateSubmissionReason
266732021-09-17New Drug Submission (NDS)

International API supply for PEMIGATINIB

1 active FDA Drug Master Files.

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