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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  10/29/2010
Trade Name:  Afinitor
Generic or Proper Name (*):  everolimus
Indications Studied:  Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis
Therapeutic Category:  Antineoplastic
Ages Studied:  3 years and older
Study #:  1
Study Type:  Efficacy/Safety
Study Design:  Open Label
No Patients:  22
No Centers:  1
No Countries:  1
Asian:  0