Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for 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 October 2025
File name
Octaplex PIL IE 20250401.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH address has changed
Updated on 27 October 2025
File name
Octaplex 500IU SmPC IE 20251017.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
MAH address has changed
Updated on 06 December 2024
File name
20240722_spc_261_500_IE_09.08.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 06 December 2024
File name
20240722_pil_261_500_1000_IE_04.03.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 06 December 2024
File name
20240722_pil_261_500_1000_IE_04.03.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 09 February 2023
File name
Octaplex 500IU IE SPC - 20200518 - July 2020.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 July 2020
File name
Octaplex PIL - 20200708 - July 2020.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 06 July 2020
File name
Octaplex IE PIL - 20200331 - July 2020.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- 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 06 July 2020
File name
Octaplex 500IU IE SPC - 20200518 - July 2020.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 15 August 2018
File name
Octaplex 500 IU IE SPC - May 2018.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 July 2018
File name
Octaplex 500 IU IE SPC - May 2018.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 July 2018
File name
Octaplex IE PIL - July 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 28 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2017
Reasons for updating
- 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
Updated on 27 November 2017
File name
PIL_16314_812.pdf
Reasons for updating
- New PIL for new product
Updated on 27 November 2017
Reasons for updating
- Change to section 4 - possible side effects
- Joint PIL superseded by individual PILs
Updated on 17 November 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 May 2015
Reasons for updating
- New PIL for medicines.ie
Updated on 17 April 2015
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
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