Basiliximab
Product Approval Information - 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
(Text),
(PDF)
Label (PDF)
Last Updated: 4/11/2001
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Date created: September 16, 2003 |