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