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Immune Globulin
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Baxter Filed an Amended BLA to Re-Start Review Process to Treat Adult Patients with PI
Dec 5, 2013Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia facilitated subcutaneous infusion to treat adult patients with ...
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CSL Behring Has Received Approval From FDA for a New 10g (50ml) Vial Size of Hizentra
Sep 6, 2013CSL Behring has received approval from the US Food and Drug Administration (FDA) for a new 10g (50mL) vial size of Hizentra, an immune globulin subcutaneous (human) liquid drug. Hizentra, which is claimed to the first and only 20% ...
Tags: CSL Behring, Hizentra
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CSL Behring's Privigen Has Obtained Marketing Authorization From The European Commission
Apr 5, 2013CSL Behring's Privigen has obtained marketing authorization from the European Commission for use in chronic inflammatory demyelinating polyneuropathy (CIDP). Privigen is an immune globulin intravenous [human], 10% liquid, developed for ...
Tags: CSL Behring Privigen, European Marketing Authorization
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US FDA Has Approved Cangene's Varizig for Post-Exposure Prophylaxis of Varicella
Jan 14, 2013The US FDA has approved Cangene's Varizig for post-exposure prophylaxis of varicella in patients including immunocompromised children, newborns and pregnant women. The hyperimmune product that contains antibodies specific for the ...
Tags: FDA, hyperimmune product, Varicella Zoster Immune Globulin, U.S.A
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CSL Behring Has Submitted a Variation Application to The EMA
Nov 28, 2012CSL Behring has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen (immune globulin intravenous [human], 10% liquid for intravenous administration) in Chronic Inflammatory Demyelinating ...
Tags: CSL Behring, Variation Application, Privigen, CIDP
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Kedrion Purchases Ortho-Clinical Diagnostics' Rho(D) Immune Globulin (Human) RhoGAM
Aug 1, 2012The Kedrion Group, a developer of plasma derived products, has purchased Ortho-Clinical Diagnostics' Rho(D) immune globulin (Human) RhoGAM and Rho(D) Immune Globulin (Human) MICRhoGAM ultra-filtered Plus products, used for the prevention of ...
Tags: plasma derived products, Immune Globulin, ultra-filtered Plus products
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Gammagard Liquid to Treat MMN Gets Approval From FDA
Jun 26, 2012Baxter International's Gammagard liquid 10% [Immune Globulin Infusion (Human)] has got approval from the US Food and Drug Administration (FDA) as a treatment for multifocal motor neuropathy (MMN). Baxter has been given Orphan Drug ...
Tags: Gammagard liquid, FDA, MMN patients
