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 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)