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: 02/11/20
(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 DOPTELET 20mg film coated tablets | Active Ingredients Avatrombopag |
| 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 2 November 2020 SPC
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 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 SPC
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 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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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 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