Fibryga, 1 g, powder and solvent for solution for injection/infusion *

  • Company:

    Octapharma Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 27 July 2021

File name

Fibryga SPC Ireland - 20210714_1627377174.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Update of Fibryga SmPC and PIL following Article 46 Paediatric Worksharing procedure

Updated on 27 July 2021

File name

Fibryga PIL Ireland - 20210714_1627377052.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Free text change information supplied by the pharmaceutical company

Update of Fibryga SmPC and PIL following Article 46 Paediatric Worksharing procedure

Updated on 11 September 2020

File name

Fibryga IE PIL - 20200608 - Sep 2020_1599834954.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 September 2020

File name

FIBRYGA IE SPC - Sep 2020 - 20200904_1599834914.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 11 September 2020

File name

FIBRYGA IE SPC - Sep 2020 - 20200904_1599834876.pdf

Reasons for updating

  • New SPC for new product

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