Fibryga, 1 g, powder and solvent for solution for injection/infusion
*Company:
Octapharma LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 March 2025
File name
20231117_pil_347_IE_05.04_en.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 27 March 2025
File name
20240131_spc_347_IE_05.04_en.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
6.3 Shelf life - has changed from 2 years to 3 years
6.5 Nature and contents of container - has changed from octaject to nextaro transfer device and particle filter removed (now within nextaro device)
6.6 Special precautions for disposal - All section has changed with reference to using the nextaro device
10 Date of revision of the text updated to January 2024
Updated on 28 February 2023
File name
20221215_347_PIL_IE_04.03_en.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 28 February 2023
File name
20221215_347_SPC_IE_04.03_en.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 09 February 2023
File name
Fibryga SPC Ireland - 20211210.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 January 2022
File name
Fibryga PIL Ireland - 20211130.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 11 January 2022
File name
Fibryga SPC Ireland - 20211210.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 July 2021
File name
Fibryga SPC Ireland - 20210714.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 11 September 2020
File name
FIBRYGA IE SPC - Sep 2020 - 20200904.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Octapharma Ltd
Address:
MAH: Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium, (Local Agent: Octapharma Ltd, Glassworks House, 32 Shudehill, Manchester, Lancashire, M4 1EZ)Medical Information E-mail:
medinfo.uk@octapharma.comTelephone:
+44 (0)161 837 3770Website:
https://www.octapharma.co.uk