Vaccines, Blood & Biologics
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Gammaplex
STN: BL 125329
Proper Name: Immune Globulin Intravenous (Human)
Tradename: Gammaplex
Manufacturer: Bio Products Laboratory
Indication:
- For the treatment of primary humoral immunodeficiency (PI)
- For the treatment of chronic immune thrombocytopenic purpura (ITP)
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Supporting Documents
March 8, 2013 Approval Letter - Gammaplex
For the treatment of chronic immune thrombocytopenic purpura (ITP)- Summary Basis for Regulatory Action - Efficacy Supplement - Gammaplex (PDF - 794KB)
October 7, 2009 Corrected Approval Letter
This letter corrects the storage temperature stated on page 1, paragraph 5.September 17, 2009 Approval Letter - Gammaplex
For the treatment of primary humoral immunodeficiency (PI)Approval History, Letters, Reviews and Related Documents - Gammaplex - Summary Basis for Regulatory Action - Gammaplex (PDF - 246KB)
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