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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.

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Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

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Food and Drug Administration

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Silver Spring, MD 20993-0002