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PALFORZIA, Peanut (Arachis hypogaea) Allergen Powder
申请企业
Aimmune Therapeutics, Inc.
药品名称
PALFORZIA, Peanut (Arachis hypogaea) Allergen Powder
承诺描述
To establish a pregnancy registry for PALFORZIA to collect, analyze, and report data on pregnancy outcomes and infant outcomes after exposure of PALFORZIA during pregnancy. You will continue enrolling patients until 72 qualifying patients are enrolled or until 5 years after PALFORZIA is commercially available, whichever is first. You will submit annual reports as well as a summary report at the end of the study, after which you will continue enrolling patients in the registry pending CBER review of the report and determination of whether the registry can be discontinued.