ALPROLIX powder and solvent for solution for injection

  • Name:

    ALPROLIX powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Eftrenonacog Alfa

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/10/20

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Summary of Product Characteristics last updated on medicines.ie: 22/10/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Swedish Orphan Biovitrum Ltd

Swedish Orphan Biovitrum Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ALPROLIX powder and solvent for solution for injection Active Ingredients Eftrenonacog Alfa
Medicine Name ELOCTA powder and solvent for solution for injection Active Ingredients efmoroctocog alfa
Medicine Name Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe Active Ingredients Anakinra
Medicine Name Orfadin 2mg, 5mg, 10mg and 20mg Capsules Active Ingredients Nitisinone
Medicine Name Orfadin 4mg/ml Oral Suspension Active Ingredients Nitisinone
1 - 0 of 5 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22 October 2020

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

Updated on 22 October 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Updated on 28 March 2019 PIL

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

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

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

Reasons for updating

  • File format updated to PDF

Updated on 13 July 2018

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 6 July 2017 SPC

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 6 July 2017

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 July 2017 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 25 October 2016 SPC

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 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 11 July 2016 SPC

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 PIL

Reasons for updating

  • New PIL for new product