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In this section: Approved Blood Products

RIASTAP

STN# 125317
Proper Name: Fibrinogen Concentrate (Human)
Tradename: RIASTAP
Manufacturer: CSL Behring GmbH
Indication:

Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Product Information

Package insert - RIASTAP

Supporting Documents

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

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