Vaccines, Blood & Biologics
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Flebogamma DIF 5%
Proper Name: Immune Globulin Intravenous (Human)
Tradename: Flebogamma DIF 5%
Manufacturer: Instituto Grifols, SA, License #1181
Indication: Replacement therapy in primary (inherited) humoral immune deficiency disorders
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Supporting Documents
January 25, 2012 Approval Letter - Flebogamma 5% DIF and 10% DIF
To revise the package insert to include information regarding virus validation of the nanofiltration step through --(b)(4)--- 20 nm planova filters for Flebogamma 5% DIF and 10% DIF.December 15, 2003 Approval - Flebogamma DIF 5%
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