RIASTAP

STN# 125317 Proper Name: Fibrinogen Concentrate (Human) Tradename: RIASTAP Manufacturer: CSL Behring GmbH Indication: Treatment of of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Product Information Package insert - RIASTAP Supporting Documents December 19, 2025 Approval Letter - RIASTAP Statistical Review - RIASTAP Clinical Review Memorandum - RIASTAP June 4, 2021 Approval Letter - RIASTAP January 16, 2009 Approval Letter - RIASTAP Summary Basis for Regulatory Action - RIASTAP (125317/0) Approval History, Letters, Reviews and Related Documents - RIASTAP