Orfadin 2mg, 5mg, 10mg and 20mg Capsules
- Name:
Orfadin 2mg, 5mg, 10mg and 20mg Capsules
- Company:
Swedish Orphan Biovitrum Ltd
- Active Ingredients:
- 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
(Click to Download)Click on this link to Download PDF directly
Swedish Orphan Biovitrum Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| 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 |
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 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 SmPC
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 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 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 3 August 2018 SmPC
Reasons for updating
- Change from joint to individual SmPCs
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 24 July 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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