Gammaplex 5% & 10%
STN: BL 125329
Proper Name: Immune Globulin Intravenous (Human) Liquid
Tradename: Gammaplex 5% & 10%
Manufacturer: Bio Products Laboratory
Indication:
- Gammaplex 5%: For the treatment of (1) primary humoral immunodeficiency (PI) in adults and pediatric patients two years of age and older; (2) chronic immune thrombocytopenic purpura (ITP)
- Gammaplex 10%: For the treatment of (1) primary humoral immunodeficiency (PI) in adults; (2) chronic immune thrombocytopenic purpura (ITP) in adults
Product Information
Supporting Documents
- April 6, 2018 Approval Letter - Gammaplex 10%
To include the use of Gammaplex 10% in Primary Immunodeficiency in children aged two years of age and older. - March 29, 2018 Summary Basis for Regulatory Action - Gammaplex 10 %
- February 2, 2017 Summary Basis for Regulatory Action - Gammaplex 10%
- February 6, 2017 Approval Letter - Gammaplex 5%
- July 30, 2015 Clinical Review - Gammaplex 5%
- July 30, 2015 Statistical Review - Gammaplex 5%
- Approval History, Letters, Reviews and Related Documents - Gammaplex
- Supporting Documents older than three years - Gammaplex