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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proper Name: Fibrinogen Concentrate (Human)
Tradename: RiaSTAP
Manufacturer: CSL Behring GmbH, License # 1765

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
Press Release: FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect
- January 16, 2009
Summary Basis for Regulatory Action (PDF - 689 KB)

Approval History, Letters, Reviews, and Related Documents


Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448