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Product Approval Information - Licensing Action

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Proper name: Coagulation Factor IX (Recombinant)
Tradename: Benefix
Manufacturer: Genetics Institute, Inc, Andover, MA, License #1163
Indication for Use: For use in the control and prevention of hemorrhagic episodes in patients with hemophilia B, including the peri-operative management of hemophilia B patients undergoing surgery
Approval Date: 2/11/97
Type of submission: Biologics license application

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Approval Letter - (PDF), (Text)

SBA - (PDF)

Label - (PDF)

Talk Paper

 

Updated March 16, 2001
 
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