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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:
06/13/2014
Trade Name:
Jetrea
Generic Name or Proper Name (*):
ocriplasmin
Indications Studied:
Adjunct to vitrectomy
Label Changes Summary:
*The use of Jetrea in pediatric patients is not recommended. *A single center, placebo controlled, clinical study to investigate a single intravitreal injection of ocriplasmin in pediatric patients as an adjunct to vitrectomy was conducted in 24 eyes of 22 patients. * There were no statistical or clinical differences between groups for the induction of total macular PVD, any of the secondary endpoints or adverse events. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
ThromboGenics, Inc.
NNPS:
FALSE
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