Orfadin 4mg/ml Oral Suspension
*Company:
Swedish Orphan Biovitrum LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 24 April 2023
File name
Orfadin 4 mg-ml SPC IE NI (Apr2023).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 January 2023
File name
SPC Orfadin 4 mg oral suspension (Oct2020).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 November 2020
File name
SPC Orfadin 4 mg oral suspension (Oct2020).pdf
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 4.8 - 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 02 November 2020
File name
PL Orfadin 4 mg oral suspension (Oct2020).pdf
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
File name
Orfadin 4 mg ml oral suspension SPC Dec 2019.pdf
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
File name
Orfadin 4 mg ml oral suspension PIL Dec 2019.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 29 April 2019
File name
Orfadin (4mg ml) PL (Mar 2019).pdf
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 26 April 2019
File name
Orfadin (4mg ml) SmPC (Mar 2019).pdf
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 April 2019
File name
Orfadin (2,5,10,20mg & 4mg ml) PL (Mar 2019).pdf
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
File name
Orfadin (4mg ml) PL (Dec 2018).pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 18 January 2019
File name
Orfadin (4mg ml) SmPC (Dec 2018).pdf
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 05 December 2018
File name
Orfadin (4mg ml) PL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 04 December 2018
File name
Orfadin (4mg ml).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 04 December 2018
File name
Orfadin (4 mg ml).pdf
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
File name
Orfadin (2,5,10,20mg & 4mg ml) SmPC (Jan 2017).pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 March 2017
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
File name
PIL_16406_799.pdf
Reasons for updating
- New PIL for new product
Updated on 14 February 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 09 November 2016
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
Reasons for updating
- Change to section 6 - date of revision
Updated on 14 July 2015
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
Updated on 07 July 2015
Reasons for updating
- New PIL for new product