ALPROLIX powder and solvent for solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Swedish Orphan Biovitrum Ltd
  • Status:

    No Recent Update
  • Legal 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

None provided

Updated on 11 July 2016

Reasons for updating

  • New PIL for new product