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Panzyga 100 mg/ml solution for infusion

  • Name:

    Panzyga 100 mg/ml solution for infusion

  • Company:
    info
  • Active Ingredients:

    Human Normal Immunoglobulin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/03/21

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Summary of Product Characteristics last updated on medicines.ie: 16/3/2021

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Octapharma Ltd

octapharma

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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
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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 16 March 2021 SPC

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 16 March 2021 PIL

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 28 February 2020 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 21 June 2019 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects

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

Updated on 21 June 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects

Updated on 5 March 2019 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 27 February 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 26 February 2019 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 22 November 2018 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 15 August 2018 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 15 August 2018 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 15 August 2018 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 29 May 2018 SPC

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)
  • Change to MA holder contact details

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

Updated on 21 May 2018 PIL

Reasons for updating

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

Updated on 19 May 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 19 May 2017 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Extension of room temperature shelf life from 6 to 9 months.

Updated on 18 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 May 2017 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 26 July 2016 SPC

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

Updated on 25 July 2016 PIL

Reasons for updating

  • New PIL for new product