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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:
12/23/2014
Trade Name:
Taclonex
Generic Name or Proper Name (*):
calcipotriene/ betamethasone dipropionate
Indications Studied:
Psoriasis vulgaris
Label Changes Summary:
*Extended the indication for psoriasis down to pediatric patients 12 to 17 years , based on adequate and well controlled studies in adults supported by a 4 week safety study in 33 patients 12 years and older. *Patients with plaque psoriasis involving 5-30% of the body surface area were treated with Taclonex Ointment for 4 weeks up to a maximum of 55.8 g per week. *Maximum weekly dose established (60 g per week)
Product Labeling:
Labeling
Sponsor:
LEO Pharma
Therapeutic Category:
Vitamin D analog
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