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Company IgG / AEs / Genzyme Corp. / / Country Japan / United States / / Event FDA Phase / / MedicalCondition Fabry's disease TO / chest pain / headache / infectious enterogastritis / nausea / rhinitis / mild bradycardia / albuminuria / Angiokeratoma / bradycardia / tachycardia / pruritus / renal dysfunction / wheezing / hypotension / proteinuria / Abdominal pain / hypertension / flushing / dyspnea / hematuria / nasal congestion / Fabry's disease / fever / vomiting / pain / urticaria / rigors / chest tightness / Mild rigors / Cough / / MedicalTreatment premedication / / Organization Food and Drug Administration Center for Biologics Evaluation and Research / Division of Clinical Trial Design / DEPARTMENT OF HEALTH / / Person Dikman / Marc Walton / James Kaiser / Colvin / Rennke / / / Position physician / Medical Officer / / / Product AGAL-1-002 / AGAL1-002 / / ProvinceOrState Maryland / /
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DEPARTMENT OF HEALTH & HUMAN SERVICES Memorandum PUBLIC H EALTH S ERVICE Food and Drug Administration