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Biology / Factor XIII deficiency / Coagulation / CSL Behring / Factor X / Bleeding / Platelet / Fibrinolysis / Clinical trial / Blood / Anatomy / Coagulation system


Summary Basis for Regulatory Action
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City

Marburg / Nashville / /

Company

AEs / CSL Behring GmbH / /

Country

Germany / /

Event

FDA Phase / /

Facility

CSL Behring facility / Vanderbilt University / Study Site Children’s Hospital of Orange County Location Orange / University of Michigan Ann Arbor / III complex / /

IndustryTerm

protein product / peri-operative management / end product / study product / carrier molecules / manufacturing process / /

MedicalCondition

headache / arthralgia / XIII deficiency / further breakthrough bleeding / hives / joint inflammation / thromboembolism / hepatitis C / erythema / breakthrough bleeding / hypersensitivity / infection / thrombosis / pruritus / congenital FXIII deficiency / rash / herniated disc / knee pain / /

MedicalTreatment

elective surgeries / appendectomy / surgery / plasmapheresis / /

Organization

M.D Offices Signatory Authority / University of Michigan Ann Arbor / Vanderbilt University / FDA / European Union / Study Site Children’s Hospital of Orange County Location Orange / FFP administration / Advisory Committee / /

Person

Daniela J. Vanco / Mahmood Epidemiology Bethany Bear / Basil Golding / /

Position

Chair / Committee / Chair Committee / /

Product

Sterile Water for Injection / I71023 / Corifact® / /

Technology

antibodies / /

SocialTag