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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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002