ALPROLIX powder and solvent for solution for injection
*Company:
Swedish Orphan Biovitrum LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 January 2024
File name
Alprolix SPC NI IE (Jan 2024).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2024
File name
Alprolix PIL NI IE (Jan 2024).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 19 January 2023
File name
Alprolix SPC NI and IE (Feb2021).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 October 2021
File name
Alprolix SPC NI and IE (Feb2021).pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Formatting updated in table 4
Updated on 22 February 2021
File name
Alprolix PIL Feb2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 22 February 2021
File name
Alprolix SPC Feb2021.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 October 2020
File name
Alprolix SmPC (Oct 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 October 2020
File name
Alprolix PL (Oct 2020).pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 28 March 2019
File name
Alprolix PL (Mar 2019).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 28 March 2019
File name
Alprolix SmPC (Mar 2019).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update the sections 4.8 and 5.1 with data from the extension study BYOND.
Updated on 24 July 2018
File name
Alprolix SmPC (July 2018).pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2018
File name
Alprolix SmPC.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC Changes:
4.4 Special warnings and precautions for use
Hypersensitivity
Allergic type hypersensitivity reactions are possible have been reported with ALPROLIX.
4.8 Undesirable effects
Post Marketing Experience
In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed.
10. DATE OF REVISION OF THE TEXT
23/06/2017 06/07/2018
Updated on 06 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 July 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4. Clinical particulars
4.2 Posology and method of administration
Inserted (additional text highlighted in bold): 100 IU/kg once every 10 days, adjust interval based on individual response. Some patients who are well-controlled on a once every 10 days regimen might be treated on an interval of 14 days or longer.
4.8 Undesirable effects
Inserted: Post Marketing Experience: In post-marketing experience, FIX inhibitor development and hypersensitivity have been observed.
10. DATE OF REVISION OF THE TEXT
Deleted: 30th Sept 2016
Inserted: 23rd June 2017
Updated on 03 July 2017
File name
PIL_16793_925.pdf
Reasons for updating
- New PIL for new product
Updated on 03 July 2017
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 25 October 2016
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Summary of Product Characteristics changes:
7. MARKETING AUTHORISATION HOLDER
Biogen removed as MAH & Swedish Orphan Biovitrum inserted.
10. DATE OF REVISION OF THE TEXT
Revision of text updated from 12th May 2016 to 30th September 2016.
Updated on 17 October 2016
Reasons for updating
- Change of manufacturer
- Change to date of revision
- Change to marketing authorisation holder
Updated on 11 July 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 July 2016
Reasons for updating
- New PIL for new product