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

Company Products

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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 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