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U.S. Department of Health and Human Services


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Trastuzumab Product Approval Information - Licensing Action 8/28/02

Proper name: Trastuzumab
Tradename: Herceptin
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Revised package insert: To include Vysis PathVysion HER2 DNA Probe, a FISH test for detecting HER2 gene amplification as a method to select patients for therapy
Approval Date: 8/28/2002
Type of submission: Biologics license application supplement


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