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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:  07/24/2008
 
Trade Name:  Navstel Intraocular Irrigating Solution Sterile
 
Generic Name or Proper Name (*):  balanced salt ophthalmic solution with hypromellose, dextrose and glutathione
 
Indications Studied:  Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye
 
Label Changes Summary:  * Safety and efficacy have been demonstrated in pediatric patients * New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon
 
NNPS:  TRUE
 
Therapeutic Category:  Ophthalmologic flush
 
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