Alteplase Product Approval Information - Licensing Action 6/18/96

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)

SBA (PDF)

Reviews

      Clinical Review I (PDF)
      Clinical Review II (PDF)