Proper Name: Immune Globulin Intravenous (Human)
Tradename: Flebogamma DIF 5% & 10 %
Manufacturer: Instituto Grifols, SA, License #1181
- Flebogamma 5% DIF: Treatment of primary (inherited) immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
- Flebogamma 10% DIF: Treatment of (1) primary (inherited) immunodeficiency; (2) chronic primary immune thrombocytopenia (ITP) in patients 2 years of age and older.
January 25, 2016 Approval Letter - FLEBOGAMMA 10% DIF(PDF - 42KB)
This letter supersedes the approval letter issued on January 8, 2016 to reflect changes to the age range.
December 2, 2015 Summary Basis of Regulatory Action - Flebogamma 10% DIF(PDF - 122KB) 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%