Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion

  • Name:

    Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Human Prothrombin Complex

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/07/18

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Summary of Product Characteristics last updated on medicines.ie: 15/8/2018

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Octapharma Ltd

octapharma

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Medicine Name LG-octaplas solution for infusion Active Ingredients Human Plasma Proteins
Medicine Name Nuwiq powder and solvent for solution for injection Active Ingredients simoctocog alfa
Medicine Name Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Panzyga 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Wilate powder and solvent for solution for injection Active Ingredients Factor VIII, von Willebrand factor
1 - 0 of 9 items.Total: Infinity pages

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 15 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 17 July 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 17 July 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 28 November 2017 SmPC

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Improved SPC layout

Updated on 28 November 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 27 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Joint PIL superseded by individual PILs

Updated on 27 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 November 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

$0$0In section 4.2 (Posology and method of administration), change to the required dosage formula for factor X rise.$0$0In section 4.8 (Undesirable effects), updated safety information and the addition of a table.$0$0In section 6.3, the shelf-life has been changed from 2 to 3 years.$0$0

Updated on 8 May 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 April 2015 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided