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U.S. Department of Health and Human Services

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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)