Product Approval Information
Proper Name: Fibrinogen Concentrate (Human)
Tradename: RiaSTAP
Manufacturer: CSL Behring GmbH, License # 1765
- Package insert (PDF, 220 KB) - January 2009
Date: January 16, 2009
Indication: For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia).
January 16, 2009 Approval Letter
FDA News: FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect
Summary Basis for Regulatory Action (PDF - 692 KB)
Approval History, Letters, Reviews, and Related Documents
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