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XYNTHA DIN 02309483

Status: Marketed
Holder: PFIZER CANADA ULC
Molecule: MOROCTOCOG ALFA

Health Canada record

Active ingredient(s)MOROCTOCOG ALFA 250 UNIT
Dosage formPowder For Solution; Kit
RouteIntravenous
ScheduleSCHEDULE D
ClassHuman
ATCB02BD02 COAGULATION FACTOR VIII
Original market date23-Jan-2009
Current status date17-Feb-2012
SourceHealth Canada DPD

Establishment licence of the holder

Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing MOROCTOCOG ALFA

DINProductCompanyFormStrengthStatus
02309491XYNTHAPFIZER CANADA ULCPowder For Solution; KitMOROCTOCOG ALFA 500 UNITMarketed
02374099XYNTHA SOLOFUSEPFIZER CANADA ULCPowder For SolutionMOROCTOCOG ALFA 3000 UNITMarketed
02374064XYNTHA SOLOFUSEPFIZER CANADA ULCPowder For SolutionMOROCTOCOG ALFA 500 UNITMarketed
02374072XYNTHA SOLOFUSEPFIZER CANADA ULCPowder For SolutionMOROCTOCOG ALFA 1000 UNITMarketed
02374080XYNTHA SOLOFUSEPFIZER CANADA ULCPowder For SolutionMOROCTOCOG ALFA 2000 UNITMarketed
02374056XYNTHA SOLOFUSEPFIZER CANADA ULCPowder For SolutionMOROCTOCOG ALFA 250 UNITApproved
02245951REFACTOWYETH CANADAPowder For SolutionMOROCTOCOG ALFA 1000 UNITCancelled Post Market
02309505XYNTHAPFIZER CANADA ULCPowder For Solution; KitMOROCTOCOG ALFA 1000 UNITDormant
02309513XYNTHAPFIZER CANADA ULCPowder For Solution; KitMOROCTOCOG ALFA 2000 UNITDormant

Notices of Compliance

NOCDateSubmissionReason
118962010-10-20New Drug Submission (NDS)Manufacturer name change
95032008-04-23Supplement to a New Drug Submission (SNDS)NEW MANUFACTURING FACILITY, NEW MANUFACTURING PROCESS, NEW 2000 IU PRESENTATION, NAME CHANGE FROM REFACTO TO XYNTHA
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