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Product Approval Information - Licensing Action

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Proper name: Antihemophilic Factor (Recombinant)
Tradename: ReFacto
Manufacturer: Genetics Institute, Inc, Andover, MA, License #1163
Indication for Use: Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A
Approval Date: 3/6/2000
Type of submission: Biologics license application

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Approval Letter - (PDF), (Text)

Label - (PDF)

SBA - (PDF)

 

Updated March 5, 2001
 
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