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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:  04/30/2009
Trade Name:  Creon
Generic Name or Proper Name (*):  pancrelipase
Indications Studied:  Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
Label Changes Summary:  * Safety and efficacy assessed in a study that included patients 12-18 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing and clinical study * Not interchangeable with other pancrelipase products * New drug
Product Labeling:  Labeling  Opens a new window
Sponsor:  Solvey
Therapeutic Category:  Pancreatic enzyme