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Flolan Injection 1.5mg (with pH 12 solvent)

  • Name:

    Flolan Injection 1.5mg (with pH 12 solvent)

  • Company:
    info
  • Active Ingredients:

    Epoprostenol Sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/01/19

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Summary of Product Characteristics last updated on medicines.ie: 11/1/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 135 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 11 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to drug interactions

Updated on 11 January 2019

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SPC sections 4.2, 6.2 and 6.6. Additional of how solution should not be prepared with materials containing PET
SPC section 4.8 - addition of unknown AE- High output cardiac failure

Updated on 30 April 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 13 October 2017 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • 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

SPC: Section 6.3 shelf life of the Sterile Diluent for Flolan has been updated from 24 months to 36 months

Updated on 13 October 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 20 March 2017 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

Updated on 20 March 2017 PIL

Reasons for updating

  • New PIL for new product