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Orfadin 2mg, 5mg, 10mg and 20mg Capsules

*
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):

    Nitisinone

    *Additional information is available within the SPC or upon request to the company

Updated on 24 April 2023

File name

Orfadin Capsules SPC IE NI (Apr2023).pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 19 January 2023

File name

SPC Orfadin 2,4,10,20 mg hard capsules (Oct2020).pdf

Reasons for updating

  • Document format updated

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

Updated on 02 November 2020

File name

SPC Orfadin 2,4,10,20 mg hard capsules (Oct2020).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 02 November 2020

File name

PL Orfadin 2,4,10,20 mg hard capsules (Oct2020).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 24 September 2020

File name

Orfadin 2,5,10 and 20mg Capsules SPC Dec 2019.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 24 September 2020

File name

Orfadin 2,5,10 and 20mg Capsules PIL Dec 2019.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 29 April 2019

File name

Orfadin (2,5,10,20mg) PL (Mar 2019).pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 26 April 2019

File name

Orfadin (2,5,10,20mg & 4mg ml) 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 26 April 2019

File name

Orfadin (2,5,10,20mg & 4mg ml) SmPC (Mar 2019).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic 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 18 January 2019

File name

Orfadin (2,5,10 & 20mg) PL (Dec 2018).pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 18 January 2019

File name

Orfadin (2,5,10 & 20mg) SmPC (Dec 2018).pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

Updated on 04 December 2018

File name

Orfadin (2,5,10,20mg).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 04 December 2018

File name

Orfadin (2,5,10,20mg).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Inserted:            Monitoring of plasma tyrosine levels:

It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.

 

10.                       Date of revision of the text

Inserted: 20/11/2018

Deleted: 26/01/2017

Updated on 03 August 2018

File name

Orfadin (2,5,10,20mg) SmPC (Jan 2017).pdf

Reasons for updating

  • Change from joint to individual SPCs

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

Updated on 24 July 2018

File name

Orfadin (2,5,10,20mg & 4mg ml) SmPC (Jan 2017).pdf

Reasons for updating

  • New SPC for new product

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

Updated on 14 February 2017

File name

PIL_16160_525.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 February 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 26 October 2016

Reasons for updating

  • Change to section 6 - date of revision

Updated on 07 July 2015

Reasons for updating

  • Change to date of revision

Updated on 19 May 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 04 November 2014

Reasons for updating

  • New PIL for medicines.ie