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Haemophilia / Orders of magnitude


CLINICAL PHARMACOLOGY BLA REVIEW Division of Hematology Office of Blood Review & Research BLA: [removed]Product: BAX326 (RIXUBIS; Recombinant Factor IX) Indication: severe or moderately severe hemophilia B
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Company

Baxter / /

Event

FDA Phase / /

IndustryTerm

manufacturing / /

MedicalTreatment

intravenous infusion / /

Organization

World Health Organization / Hematology Office / CLINICAL PHARMACOLOGY BLA REVIEW Division / /

Person

Edward M Thomson / Anne Pilaro / /

Product

Sterile Water for Injection / BAX326 / /

Technology

pharmacokinetics / recombinant DNA technology / Pharmacodynamics / /

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