Product Approval Information
Proper Name: Rh0(D) Immune Globulin Intravenous (Human)
Tradename: Rhophylac
Manufacturer: CSL Behring AG, License #1766
Package Insert (PDF - 221 KB) - Approved: March 16, 2007
Date: February 12, 2004
Indication: Routine antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women, for Rhesus prophylaxis in case of obstetric complications, for Rhesus prophylaxis in case of invasive procedures during pregnancy, and for the suppression of Rhesus immunization in Rho(D)-negative individuals transfused with Rho(D)-positive red blood cells (RBCs) or blood components containing Rho(D)-positive RBCs
February 12, 2004 Approval Letter
Summary of Basis for Approval (PDF - 50 KB)