Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    Octapharma Ltd
  • Status:

    No Recent Update
  • Legal 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 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

Improved SPC layout

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

$0$0In section 4.2 (Posology and method of administration), change to the required dosage formula for factor X rise.$0$0In section 4.8 (Undesirable effects), updated safety information and the addition of a table.$0$0In section 6.3, the shelf-life has been changed from 2 to 3 years.$0$0

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)

Free text change information supplied by the pharmaceutical company

None provided