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ALPROLIX DIN 02422948

Status: Marketed
Holder: SANOFI-AVENTIS CANADA INC
Molecule: RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN

Health Canada record

Active ingredient(s)RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 2000 UNIT
Dosage formPowder For Solution; Kit
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02BD04 COAGULATION FACTOR IX
Original market date11-Dec-2015
Current status date22-Sep-2021
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 RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN

DINProductCompanyFormStrengthStatus
02422905ALPROLIXSANOFI-AVENTIS CANADA INCPowder For Solution; KitRECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 250 UNITApproved
02422913ALPROLIXSANOFI-AVENTIS CANADA INCPowder For Solution; KitRECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 500 UNITMarketed
02474034ALPROLIXSANOFI-AVENTIS CANADA INCKit; Powder For SolutionRECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 4000 UNITApproved
02422956ALPROLIXSANOFI-AVENTIS CANADA INCPowder For Solution; KitRECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 3000 UNITMarketed
02422921ALPROLIXSANOFI-AVENTIS CANADA INCKit; Powder For SolutionRECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 1000 UNITMarketed

Notices of Compliance

NOCDateSubmissionReason
193112017-05-17New Drug Submission (NDS)MERGER - BUYOUT
154352014-03-20New Drug Submission (NDS)
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