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Product Approval Information - Licensing Action

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Proper name: Immune Globulin Intravenous (Human)
Tradename: Flebogamma
Manufacturer: Instituto Grifols, SA, Barcelona, Spain, License #1181
Indication for Use: Replacement therapy in primary (inherited) humoral immune deficiency disorders
Approval Date: 12/15/2003
Type of submission: Biologics license application

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Approval Letter - (Text)

Labeling - (PDF)

 

Updated December 15, 2003
 
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