• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Alteplase Product Approval Information - Licensing Action 5/15/02

Proper name: Alteplase
Tradename: Activase
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Labeling Change: Include adding information regarding orolingual angioedema to the Precautions and Adverse Reactions sections, and bolding a statement in the Dosage and Administration section
Approval Date: 5/15/2002
Type of submission: Biologics license supplement


Approval Letter - (PDF)

Label - (PDF)