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Rhophylac Approval History

FDA Approved: Yes (First approved February 12, 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

DateArticle
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

Further information

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