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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Profilnine SD - Factor IX Complex

STN: 102476
Proper Name: Factor IX Complex
Trade Name: Profilnine® SD
Manufacture: Grifols Biologicals Inc.
Indication:  for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.


Supporting 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