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Human Albumin Baxalta 50 g/l Solution for Infusion

  • Name:

    Human Albumin Baxalta 50 g/l Solution for Infusion

  • Company:
    info
  • Active Ingredients:

    Human Albumin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/02/20

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Summary of Product Characteristics last updated on medicines.ie: 5/12/2017
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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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1 - 0 of 62 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 6 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 5 December 2017 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The change involves an editorial quality change affecting the SmPC sections 2 and 6.1. 
In section 2  the excipient with known effect has been updated to Sodium 13 - 160 mmol/l.
In section 6.1, the excipient Sodium has been amended to Sodium Chloride q.s and a "Total sodium content 130 - 160 mmol/l" has been added.   
The date of revision (section 10) has been updated to November 2017. 

 

 

 

 

 

 

Updated on 5 December 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 16 November 2016 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

In section 6.1 - Change in the expression of the sodium content of the drug product in the list of excipients

Updated on 21 July 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 21 July 2016 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.8 - "Baxter-sponsored clinical trials" amended to "company-sponsored clinical trials"

Updated on 21 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 February 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2016 SPC

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