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Trastuzumab
Product Approval Information - Licensing Action
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
Approval Letter
(Text)
Label
(PDF)
Last Updated: 12/10/2002
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Updated: September 25, 2003 |
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