Advate F. Environmental Assessment Baxter Healthcare Corporation / Controls A. Manufacturing / Baxter Healthcare Corporation / /
Country
Switzerland / Austria / /
Event
FDA Phase / Product Issues / /
Facility
Baxter Healthcare Corporation facility / /
IndustryTerm
real time data / final drug product / licensed pharmaceutical product / treatment of von Willebrand’s disease / manufacturing practice standards / final product / final bulk drug product / final container product / peri-operative management / drug product / real time stability data / physico-chemical properties / manufacturing method / test product / licensed product / manufacturing facilities / cell culture manufacturing process / parenteral drug products / reconstituted drug product / product manufacturing / manufacturing process / /
MedicalCondition
limb injury / classical hemophilia / hemophilia A / nasopharyngitis / sterility / VIII deficiency / pain / von Willebrand’s disease / bovine spongiform encephalopathy / MS / /
MedicalTreatment
intravenous infusion / surgery / /
Organization
MCB / World Health Organization / WCB / FDA / Center for Biologics Evaluation and Research / /
Position
investigator / physician / /
Product
sodium chloride / calcium chloride / mannitol / sterile water for injection / Advate / mice / /
SBA - Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) (ADVATE)