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Brand NameProlia
Generic Namedenosumab
Marketed byAMGEN
NDA/BLA HolderAmgen
NDA/BLA NumberBLA 125320
NDA/BLA Approval Date06/01/2010
Review ClassificationN/A
REMS Approval Date06/01/2010
Class REMSNo
REMS Source Document
Boxed Warning?
Boxed Warning
Route of Administration
Mechanism of Action
Risks (MedGuide Language)
Approved Labeling
Medication Guide?
Medication Guide
Medication Guide Version
Communication Plan?
Communication Plan
Elements to Assure Safe Use?
Elements to Assure Safe Use
Implementation System?
Implementation System
Assessment Program
Assessment Program Timeline
Branded Program
Program Description
Link to Branded Program
Approval Letters


REMS Document: from FDA Approved REMS

Approval Letters: from FDA Medication Guide Website

Approved Labeling: from FDA Medication Guide Website

Medication Guide: from FDA Medication Guide Website

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