Orfadin 4mg/ml Oral Suspension

  • Name:

    Orfadin 4mg/ml Oral Suspension

  • 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: 29/04/19

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Summary of Product Characteristics last updated on medicines.ie: 26/4/2019

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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
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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 29 April 2019 PIL

Reasons for updating

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

Updated on 26 April 2019 SmPC

Reasons for updating

  • New individual SmPC (was previously included in combined SmPC)

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

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 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 SmPC

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 5 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 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 SmPC

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 24 July 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 7 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 March 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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)

Free text change information supplied by the pharmaceutical company

4.         Clinical particulars

4.2       Posology and method of administration

 

5.         PHARMACOLOGICAL PROPERTIES

5.1       Pharmacodynamic properties - Clinical efficacy and safety

 

Change of the posology in Section 4.2 in the SmPC to once daily dosing in patients with body weight <20 kg. Update of efficacy data presentation in Section 5.1 in SmPC under Clinical efficacy and safety.

Addition of supporting data in section 5.1 of SmPC.

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 9 November 2016 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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:

5. PHARMACOLOGICAL PROPERTIES
5.3       Preclinical safety data

 

Deleted text: Carcinogenicity studies have not been performed. 

 Inserted text: Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2).


10. DATE OF REVISION OF THE TEXT

 

Deleted: 19th June 2015

Inserted: 15th September 2016

Updated on 26 October 2016 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 July 2015 SmPC

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 7 July 2015 PIL

Reasons for updating

  • New PIL for new product