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U.S. Department of Health and Human Services

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Basiliximab Approval Info - Licensing Action

Proper name: Basiliximab
Tradename: Simulect
Manufacturer: Novartis Pharmaceutical Corp, East Hanover, NJ, License #1244
Indication for Use: Use in renal transplantation in combination with triple immunosuppressive therapy; use in pediatric renal transplantation; and use of an IV bolus injection
Approval Date: 3/23/2001
Type of submission: Biologics license application supplement

 


Approval Letter (PDF)

Label (PDF)