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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:
06/20/2019
Trade Name:
Botox
Generic Name or Proper Name (*):
onabotulinumtoxinA
Indications Studied:
Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age
Label Changes Summary:
*Safety and effectiveness for the treatment of upper limb spasticity have been established in pediatric patients 2 to 17 years of age, in a clinical study of 234 patients. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
PREA(P):
P
Sponsor:
Allergan
NNPS:
FALSE
Therapeutic Category:
Antispasmodic
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