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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Supporting Documents
August 26, 2010 Approval Letter, STN: BL 102476/5218 - Profilnine® SD
To include the change to a new Medimop Mix2Vial Reconstitution System and the revised Package Insert.
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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
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