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OBIZUR 500 U powder and solvent for solution for injection

  • Name:

    OBIZUR 500 U powder and solvent for solution for injection

  • Company:
    info
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/06/17

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Summary of Product Characteristics last updated on medicines.ie: 18/4/2017
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Shire Pharmaceuticals Limited

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Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

Company Products

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Medicine Name CEPROTIN 1000 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name CEPROTIN 500 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name Cuvitru 200 mg/ml solution for subcutaneous injection Active Ingredients Human Normal Immunoglobulin
Medicine Name FEIBA 25 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name FEIBA 50 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name Flexbumin 200 g/l solution for infusion Active Ingredients Human Albumin
Medicine Name GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Human Albumin Baxalta 50 g/l Solution for Infusion Active Ingredients Human Albumin
Medicine Name HyQvia 100 mg/ml solution for infusion for subcutaneous use Active Ingredients Human Normal Immunoglobulin
Medicine Name KIOVIG 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name OBIZUR 500 U powder and solvent for solution for injection Active Ingredients
Medicine Name Prothromplex TOTAL 600 IU powder and solvent for solution for injection Active Ingredients Human Prothrombin Complex
Medicine Name Revestive 1.25 mg powder and solvent for solution for injection Active Ingredients Teduglutide
Medicine Name Revestive 5 mg powder and solvent for solution for injection Active Ingredients Teduglutide
Medicine Name SUBCUVIA 160 g/l Solution for injection Active Ingredients Human Normal Immunoglobulin
Medicine Name VEYVONDI 650 IU and 1300 IU powder and solvent for solution for injection Active Ingredients Vonicog alfa
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 8 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 8 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 April 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 24 to 30 months. 
In section 9, the date of first authorization has been included.

Updated on 18 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 June 2016 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided