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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:
12/08/2017
Trade Name:
Omidria intraocular solution
Generic Name or Proper Name (*):
phenylephrine and ketorolac
Indications Studied:
Prevention of intraoperative miosis and reduction of postoperative pain in patients who have undergone cataract surgery
Label Changes Summary:
*Safety and effectiveness have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). * Use in this population is supported by evidence from adequate and well-controlled studies of Omidria in adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old. *The safety profile in children was similar to that observed in adults. *Information on adverse reactions and clinical trials.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Omeros Corporation
NNPS:
FALSE
Therapeutic Category:
Analgesic, topical
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