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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
07/29/2016
Trade Name:
Dysport
Generic Name or Proper Name (*):
abobotulinumtoxinA
Indications Studied:
Treatment of lower limb spasticity in pediatric patients 2 years of age and older
Label Changes Summary:
*Indicated for the treatment of lower limb spasticity in pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated. *Safety and effectiveness of Dysport injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established. *The most commonly observed adverse reactions were upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough and pyrexia. *Information on dosing, preparation and administration, adverse reactions, and clinical trial. *New indication.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Ipsen Biopharmaceuticals, Inc.
NNPS:
FALSE
Therapeutic Category:
neuromuscular blocking agent
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