Octaplex 1000 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_1000_IE_11.10.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 February 2023
File name
Octaplex 1000IU SmPC IE 20210706.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2023
File name
Octaplex SmPC IE 20210706.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Other
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 1000IU 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 11 May 2020
File name
Octaplex IE SPC - May 2020 - 20200429.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 1000 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 1000 IU IE SPC - May 2018.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPCs for Octaplex 500 IU and 1000 IU have been split.
Updated on 17 July 2018
File name
Octaplex IE PIL - July 2018.pdf
Reasons for updating
- New PIL for new product