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ESPEROCT DIN 02490102

Status: Marketed
Holder: NOVO NORDISK CANADA INC
Molecule: ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED

Health Canada record

Active ingredient(s)ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 3000 UNIT
Dosage formPowder For Solution
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02BD02 COAGULATION FACTOR VIII
Original market date15-Sep-2022
Current status date15-Sep-2022
SourceHealth Canada DPD

Establishment licence of the holder

Novo Nordisk Canada Inc — licence 100175, currently licensed, last inspection rating C (2023-02-13).

No Canadian shortage report is currently matched to this DIN.

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

DINProductCompanyFormStrengthStatus
02490064ESPEROCTNOVO NORDISK CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 500 UNITMarketed
02490072ESPEROCTNOVO NORDISK CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1000 UNITMarketed
02490080ESPEROCTNOVO NORDISK CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1500 UNITApproved
02490099ESPEROCTNOVO NORDISK CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 2000 UNITMarketed

Notices of Compliance

NOCDateSubmissionReason
223862019-07-04New Drug Submission (NDS)
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