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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Ipsen Biopharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  neuromuscular blocking agent
 
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