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Hereditary angioedema / Angioedema / C1-inhibitor / Anatomy / CSL Behring / Acquired C1 esterase inhibitor deficiency / Complement deficiency / Health / Medicine


SBRA STN[removed]Summary Basis for Regulatory Action Date
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City

Marburg / /

Company

Case Management / C1 / Hershey / CSL Behring GmbH / /

Country

United States / /

Event

FDA Phase / Product Issues / Product Recall / /

Facility

Penn State University / /

IndustryTerm

extension protocol / reactive site / body site / earlier protocol / active product / aqueous solution / cascade systems / /

MedicalCondition

drug addiction / laryngeal edema / inflammatory process / HAE / Allergy / medication Acquired angioedema / pain / C1-Esterase Inhibitor Deficiency / acute laryngeal edema / hereditary angioedema / angioedema / hypersensitivity / End-stage liver disease / /

MedicalTreatment

retreatment / /

Movie

Half-life / /

Organization

Administration of Berinert / office of Compliance and Biologics Quality / Data Safety Monitoring Board / Berinert administration / Division of Case Management / Penn State University / Basil Golding____________________________ Offices Signatory Authority / /

Person

Erin Mcdowell Facilities / Mary Lin / Solomon Yiman / Iftekhar Mahmood / L. Ross Pierce / Timothy Craig / Konrad Bork / Lot Release / Basil Golding / Nannette Cagungun / /

/

Position

coordinating investigator / investigator / Alpita Popat Regulatory Project Manager / Chair / Committee / Chair Committee / /

Product

Sodium Chloride / INH / Glycine / consent / aminocaproic acid / Sterile Water for Injection / CE1145 / Berinert / /

ProvinceOrState

Pennsylvania / /

PublishedMedium

the Impact / Archives of Internal Medicine / /

Technology

Pharmacokinetics / 2 Study Protocol / earlier protocol / extension protocol / /

SocialTag