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JIVI DIN 02481790

Status: Marketed
Holder: BAYER INC
Molecule: ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED)

Health Canada record

Active ingredient(s)ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 3000 UNIT
Dosage formPowder For Solution
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02BD02 COAGULATION FACTOR VIII
Original market date27-Jan-2020
Current status date27-Jan-2020
SourceHealth Canada DPD

Establishment licence of the holder

Bayer Inc — licence 101029, currently licensed, last inspection rating C (2023-02-07).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED)

DINProductCompanyFormStrengthStatus
02481766JIVIBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 500 UNITMarketed
02481774JIVIBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 1000 UNITMarketed
02481782JIVIBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 2000 UNITMarketed
02481758JIVIBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) 250 UNITCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
214372018-10-18New Drug Submission (NDS)
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