Flebogamma DIF 5% & 10%
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.
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
- January 8, 2016 - FLEBOGAMMA 10% DIF
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
- Supporting Documents older than three years - Flebogamma DIF 5% and 10%