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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:  10/30/2007
 
Trade Name:  Combigan 0.2%/0.5% ophthalmic solution
 
Generic Name or Proper Name (*):  brimonidine tartrate/timolol maleate
 
Indications Studied:  Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
 
Label Changes Summary:  * Safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2  7 years old * Not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants * Safety and effectiveness have not been studied in children below the age of two years * New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  TRUE
 
Therapeutic Category:  Ophthalmologic hypotensive
 
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