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Product Approval Information - Licensing Action

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Proper name: Rho(D) Immune Globulin Intravenous (Human)
Tradename: Rhophylac
Manufacturer: ZLB Bioplasma AG, Switzerland, License #1598
Indication for Use: 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
Approval Date: 2/12/2004
Type of submission: Biologics license application

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Approval Letter - (Text)

Labeling - (PDF)

 

Updated February 19, 2004
 
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