Alteplase
Product Approval Information - Licensing Action
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 -
(Text),
(PDF)
Label - (PDF)
Last Updated: 5/17/2002
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Date created: September 16, 2003 |