Flebogamma DIF 5%
Proper Name: Immune Globulin Intravenous (Human)
Tradename: Flebogamma DIF 5%
Manufacturer: Instituto Grifols, SA, License #1181
- Treatment of primary (inherited) immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
September 23, 2013 Approval Letter - FLEBOGAMMA 5% DIF
Approval Letter for Safety Labeling Changes
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%