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ALTUVIIIO DIN 02448114

Status: Approved
Holder: SANOFI-AVENTIS CANADA INC
Molecule: *ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN

Health Canada record

Active ingredient(s)*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 250 UNIT
Dosage formPowder For Solution
RouteIntravenous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCB02BD02 COAGULATION FACTOR VIII
Original market date
Current status date26-Mar-2025
SourceHealth Canada DPD

Establishment licence of the holder

sanofi-aventis Canada Inc. — licence 101470, currently licensed, last inspection rating C (2026-02-17).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing *ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN

DINProductCompanyFormStrengthStatus
02447967ALTUVIIIOSANOFI-AVENTIS CANADA INCPowder For Solution*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 3000 UNITMarketed
02448122ALTUVIIIOSANOFI-AVENTIS CANADA INCPowder For Solution*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 500 UNITMarketed
02448130ALTUVIIIOSANOFI-AVENTIS CANADA INCPowder For Solution*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 1000 UNITMarketed
02448149ALTUVIIIOSANOFI-AVENTIS CANADA INCPowder For Solution*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 2000 UNITMarketed
02448157ALTUVIIIOSANOFI-AVENTIS CANADA INCPowder For Solution*ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, BDD), FC-VWF-XTEN FUSION PROTEIN 4000 UNITMarketed

Notices of Compliance

NOCDateSubmissionReason
350792025-03-26New Drug Submission (NDS)
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