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KOGENATE - PWS IV 500I.U./VIAL DIN 02178826

Status: Cancelled Post Market
Holder: BAYER CORPORATION
Molecule: ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Health Canada record

Active ingredient(s)ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT
Dosage formPowder For Solution
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02BD02 COAGULATION FACTOR VIII
Original market date20-Nov-1996
Current status date01-Aug-2002
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)

DINProductCompanyFormStrengthStatus
02365987ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNITApproved
02446448ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITApproved
02446421ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITApproved
02446413ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITApproved
02446405ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITApproved
02365979ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITApproved
02446480ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITApproved
02446472ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITApproved
02446464ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNITApproved
02446456ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNITApproved
02451492KOVALTRYBAYER INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITMarketed
02451484KOVALTRYBAYER INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITMarketed
02451476KOVALTRYBAYER INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITMarketed
02451468KOVALTRYBAYER INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITMarketed
02451441KOVALTRYBAYER INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITMarketed
02365952ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITDormant
02284138ADVATEBAXTER HEALTHCARE CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02284146ADVATEBAXTER HEALTHCARE CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market
02284154ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITDormant
02284162ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNITDormant
02313111ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITDormant
02337193ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITDormant
02365944ADVATETAKEDA CANADA INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITDormant
02308592HELIXATE FSBAYER HEALTHCARE LLCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITCancelled Post Market
02243187HELIXATE FSBAYER HEALTHCARE LLCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market
02243188HELIXATE FSBAYER HEALTHCARE LLCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02243186HELIXATE FSBAYER HEALTHCARE LLCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02342723HELIXATE FSBAYER HEALTHCARE LLCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITCancelled Pre Market
02178834KOGENATE - PWS IV 1000I.U./VIALBAYER CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02178818KOGENATE - PWS IV 250I.U./VIALBAYER CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02291525KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market
02302217KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITCancelled Post Market
02342731KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITCancelled Post Market
02254484KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market
02254476KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02242491KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02242490KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market
02242489KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02254492KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02291517KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02291533KOGENATE FSBAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02342758KOGENATE FS -(WITH BIO-SET)BAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITCancelled Post Market
02302225KOGENATE FS -(WITH BIO-SET)BAYER INCPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITCancelled Post Market
02042517KOGENATE PWS 1000IU/VIALMILES INC. - PHARMACEUTICAL DIVISIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02042495KOGENATE PWS 250IU/VIALMILES INC. - PHARMACEUTICAL DIVISIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02042509KOGENATE PWS 500IU/VIALMILES INC. - PHARMACEUTICAL DIVISIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market
02451603KOVALTRYBAYER INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Pre Market
02451638KOVALTRYBAYER INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Pre Market
02451611KOVALTRYBAYER INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Pre Market
02451646KOVALTRYBAYER INCPowder For Solution; KitANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNITCancelled Pre Market
02451654KOVALTRYBAYER INCKit; Powder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNITCancelled Pre Market
02015137RECOMBINATE PWS INJ 1000I.U./VIALBAXTER HEALTHCARE CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNITCancelled Post Market
02015129RECOMBINATE PWS INJ 250I.U./VIALBAXTER HEALTHCARE CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNITCancelled Post Market
02015145RECOMBINATE PWS INJ 500I.U./VIALBAXTER HEALTHCARE CORPORATIONPowder For SolutionANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNITCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
42111996-09-30Supplement to a New Drug Submission (SNDS)CHANGES TO MANUFACTURING SITE
42081996-03-11Supplement to a New Drug Submission (SNDS)ALTERNATE FERMENTATION AND PURIFICATION SITE
48611995-08-04New Drug Submission (NDS)CHANGE IN MANUFACTURER'S NAME, CHANGES TO THGE LABELLING AND PRODUCT MONOGRAPH
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