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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Nitisinone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/11/20

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Summary of Product Characteristics last updated on medicines.ie: 2/11/2020

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Swedish Orphan Biovitrum Ltd

Swedish Orphan Biovitrum Ltd

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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
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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 2 November 2020

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

Updated on 2 November 2020 PIL

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

Reasons for updating

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

Updated on 24 September 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 29 April 2019 PIL

Reasons for updating

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

Updated on 26 April 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 26 April 2019

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

Updated on 18 January 2019 PIL

Reasons for updating

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

Updated on 18 January 2019

Reasons for updating

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

Updated on 4 December 2018 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 4 December 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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 3 August 2018

Reasons for updating

  • Change from joint to individual SmPCs

Updated on 24 July 2018

Reasons for updating

  • New SmPC for new product

Updated on 14 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 February 2017 PIL

Reasons for updating

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

Updated on 26 October 2016 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 7 July 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 May 2015 PIL

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 4 November 2014 PIL

Reasons for updating

  • New PIL for medicines.ie