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Growth factors / Cytokines / Oncology / Hematology / Filgrastim / Granulocyte colony-stimulating factor / Neutropenia / Chemotherapy / Febrile neutropenia / Medicine / Biology / Amgen


Tbo-Filgrastim Advisory Committee Briefing Document 03 April[removed]FDA Medical Imaging Drugs Advisory Committee and
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Company

G-CSF / Branded Pharmaceutical Products R&D Inc. / Amgen / Teva / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

filgrastim product / /

MedicalCondition

DF / chemotherapy-induced neutropenia / Cancer / gastrointestinal and pulmonary infections / Acute Respiratory Distress Syndrome / neutropenia / febrile neutropenia granulocyte colony-stimulating / fever / Pain / breast cancer receiving myeloablative chemotherapy / Febrile Neutropenia / Lung Cancer / Allergic Reactions / Non-Hodgkin Lymphoma / infection / Breast Cancer / Anemia / sepsis / Severe Neutropenia / /

MedicalTreatment

chemo / antibiotics / chemotherapy / /

Organization

European Medicines Agency / FDA / European Union / FDA Medical Imaging Drugs Advisory Committee / United States Food and Drug Administration / /

Person

EMA EU / MIU NA NME PBPC PD / /

Product

prednisolone / Neupogen / cyclophosphamide / XM02-01 / XM02-02INT / XM02 / CD34 / XM02-02 / /

Technology

pharmacokinetics / chemotherapy / pharmacodynamics / Medical Imaging / /

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