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Alteplase
Product Approval Information - Licensing Action
Proper name: Alteplase
Tradename: Activase
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Management of acute ischemic stroke in adults, for improving neurological recovery, and reducing the incidence of disability
Approval Date: 6/18/96
Type of submission: Product license supplement
Approval Letter
(PDF),
(Text)
SBA (PDF)
Reviews
Clinical Review I (PDF)
Clinical Review II (PDF)
Last Updated: 3/5/2001
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Date created: September 16, 2003 |
