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
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