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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  08/21/2009
Trade Name:  Xyzal
Generic or Proper Name (*):  levocetirizine dihydrochloride
Indications Studied:  Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older
Therapeutic Category:  Antihistamine
Ages Studied:  6 months and older
Study #:  3
Study Type:  Safety
Study Design:  Single-Blind
No Patients:  173
No Centers:  29
No Countries:  1