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U.S. Department of Health and Human Services


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Daclizumab Product Approval Information - Licensing Action

Proper name: Daclizumab
Tradename: Zenapax
Manufacturer: Hoffman-La Roche Inc, Nutley, NJ, License #0136
Revised Package Insert: Include pediatric use and update the Clinical Pharmacology, Clinical Studies, and Adverse Reactions sections of the package insert with three year posttransplant data
Approval Date: 7/29/2002
Type of submission: Biologics license application supplement


Approval Letter (PDF)

Label (PDF)