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

• Package Insert - Gammaplex 5%
• Package Insert - Gammaplex 10%

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