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Rhophylac Approval History

  • FDA approved: Yes (First approved February 12th, 2004)
  • Brand name: Rhophylac
  • Generic name: Rh0(D) immune globulin intravenous (human)
  • Dosage form: Injection
  • Company: ZLB Bioplasma AG, Switzerland
  • Treatment for: Rh-Isoimmunization, Idiopathic Thrombocytopenic Purpura

Rhophylac (Rh0(D) immune globulin intravenous (human)) is indicated for the suppression of rhesus (Rh) isoimmunization in pregnancy, obstetric conditions and incompatible transfusions, and the treatment of immune thrombocytopenic purpura.

Development History and FDA Approval Process for Rhophylac

Apr  2, 2007Approval FDA Approves Rhophylac for the Treatment of Immune Thrombocytopenic Purpura (ITP)
Feb 12, 2004Approval Rhophylac ZLB Bioplasma AG, Switzerland - Treatment for Prevention of Rho(D) Sensitization

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