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U.S. Department of Health and Human Services


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Oprelvekin Product Approval Information - Licensing Action

Proper name: Oprelvekin
Tradename: Neumega
Manufacturer: Genetics Institute, Inc, St. Davids, PA, License #1163
Revised Package Insert: To state that a safe and effective dose has not been established for pediatric patients and to add important new safety information
Approval Date: 9/18/2002
Type of submission: Biologics license application supplement


Approval Letter - (PDF)

Label (PDF)