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ADYNOVATE DIN 02498561

Status: Approved
Holder: TAKEDA CANADA INC
Molecule: ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED

Health Canada record

Active ingredient(s)ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 750 UNIT
Dosage formPowder For Solution; Kit
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02BD02 COAGULATION FACTOR VIII
Original market date
Current status date15-Jan-2021
SourceHealth Canada DPD

Establishment licence of the holder

Takeda Canada Inc. — licence 101769, currently licensed, last inspection rating C (2026-02-24).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED

DINProductCompanyFormStrengthStatus
02498626ADYNOVATETAKEDA CANADA INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 3000 UNITMarketed
02459078ADYNOVATETAKEDA CANADA INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 2000 UNITMarketed
02498537ADYNOVATETAKEDA CANADA INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 250 UNITMarketed
02498545ADYNOVATETAKEDA CANADA INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 500 UNITMarketed
02498553ADYNOVATETAKEDA CANADA INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 750 UNITApproved
02498588ADYNOVATETAKEDA CANADA INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 1000 UNITMarketed
02498596ADYNOVATETAKEDA CANADA INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 1500 UNITMarketed
02498618ADYNOVATETAKEDA CANADA INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 1500 UNITApproved
02459051ADYNOVATETAKEDA CANADA INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 1000 UNITDormant
02459035ADYNOVATETAKEDA CANADA INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 250 UNITDormant
02459043ADYNOVATETAKEDA CANADA INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED 500 UNITDormant

Notices of Compliance

NOCDateSubmissionReason
250212021-01-15New Drug Submission (NDS)TRANSFER OF DRUG IDENTIFICATION NUMBER (DIN). LABELLING UPDATES
235462020-05-01Supplement to a New Drug Submission (SNDS)NEW STRENGTHS
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