Product Approval Information - Licensing Action
Proper name: Antihemophilic Factor/von Willebrand Factor Complex (Human)
Tradename: Humate-P
Manufacturer: Centeon Pharma G.m.b.H., Marburg, Germany, License #1202
Indication for Use: For use in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate
Approval Date: 4/1/99
Type of submission: Product license application
Approval Letter -
(PDF),
(Text)
Label - (PDF)
SBA - (PDF)
Talkpaper
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