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PROLIA DIN 02343541

Status: Marketed
Holder: AMGEN CANADA INC
Molecule: DENOSUMAB
Available to quote

Health Canada record

Active ingredient(s)DENOSUMAB 60 MG
Dosage formSolution
RouteSubcutaneous
SchedulePRESCRIPTION; SCHEDULE D
ClassHuman
ATCM05BX04 DENOSUMAB
Original market date12-Aug-2010
Current status date12-Aug-2010
SourceHealth Canada DPD

Establishment licence of the holder

Amgen Canada Inc — licence 100048, currently licensed, last inspection rating C (2023-03-01).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing DENOSUMAB

DINProductCompanyFormStrengthStatus
02565951BILDYOSSHANGHAI HENLIUS BIOTECH, INC.SolutionDENOSUMAB 60 MGMarketed
02565943BILDYOSSHANGHAI HENLIUS BIOTECH, INC.SolutionDENOSUMAB 60 MGApproved
02567679BOMYNTRAFRESENIUS KABI CANADA LTDSolutionDENOSUMAB 120 MGApproved
02567687BOMYNTRAFRESENIUS KABI CANADA LTDSolutionDENOSUMAB 120 MGApproved
02567253BOSAYABIOCON BIOLOGICS CANADA INCSolutionDENOSUMAB 60 MGApproved
02567660CONEXXENCEFRESENIUS KABI CANADA LTDSolutionDENOSUMAB 60 MGApproved
02566265DENOZAAPOTEX INCSolutionDENOSUMAB 60 MGMarketed
02566273IDENOSAPOTEX INCSolutionDENOSUMAB 120 MGApproved
02545411JUBBONTISANDOZ CANADA INCORPORATEDSolutionDENOSUMAB 60 MGMarketed
02567482OBODENCESAMSUNG BIOEPIS CO., LTDSolutionDENOSUMAB 60 MGApproved
02569787ODENSIFYJAMP PHARMA CORPORATIONSolutionDENOSUMAB 60 MGApproved
02560895OSENVELTCELLTRION INC.SolutionDENOSUMAB 120 MGMarketed
02570750QOSEQUMANTRA PHARMA INCSolutionDENOSUMAB 60 MGApproved
02560917STOBOCLOCELLTRION INC.SolutionDENOSUMAB 60 MGMarketed
02566001TUZEMTYSHANGHAI HENLIUS BIOTECH, INC.SolutionDENOSUMAB 120 MGMarketed
02567261VEVZUOBIOCON BIOLOGICS CANADA INCSolutionDENOSUMAB 120 MGApproved
02545764WYOSTSANDOZ CANADA INCORPORATEDSolutionDENOSUMAB 120 MGMarketed
02566923XBRYKSAMSUNG BIOEPIS CO., LTDSolutionDENOSUMAB 120 MGApproved
02569795XDENOJAMP PHARMA CORPORATIONSolutionDENOSUMAB 120 MGApproved
02368153XGEVAAMGEN CANADA INCSolutionDENOSUMAB 120 MGMarketed
02343568PROLIAAMGEN CANADA INCSolutionDENOSUMAB 60 MGCancelled Pre Market

Notices of Compliance

NOCDateSubmissionReason
116492010-08-06New Drug Submission (NDS)
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