Dysport Injection

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Brand NameDysport Injection
Generic Nameabobotulinumtoxin A
Marketed byIpsen Medicis Pharmaceutical Corp.
NDA/BLA HolderIpsen
NDA/BLA NumberBLA 125274/0, 125274/1
NDA/BLA Approval Date4/30/2009
Review ClassificationNot Applicable
REMS Approval Date4/29/2009
Class REMSBotulinum Toxin
REMS Source Document
Boxed Warning?
Boxed Warning
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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
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Implementation System
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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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