Tegsedi 284 mg solution for injection in pre-filled syringe
*Company:
Swedish Orphan Biovitrum LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
Risk Management Material-Patient Card-24-06-Tegsedi-UK & ROI.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Tegsedi (inotersen) is removed from the additional monitoring list as a new biological following five years of authorisation. Therefore, the statement that this medicinal product is subject to additional monitoring and that this will allow quick identification of new safety information, preceded by an inverted equilateral black triangle, is removed from the product information and the educational material now reflects this.
Updated on 01 February 2024
File name
Tegsedi SPC IE (Jan 2024).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 February 2024
File name
Tegsedi PIL IE (Jan 2024).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 02 May 2023
File name
Tegsedi SPC IE (Apr 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 May 2023
File name
Tegsedi SPC IE (Apr 2023).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 May 2023
File name
Tegsedi PIL IE (Apr 2023).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 05 April 2023
File name
Tegsedi SPC IE (Mar 2023).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2023
File name
Tegsedi PIL IE (Mar 2023).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 05 April 2023
File name
Tegsedi PIL IE (Apr 2023).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 08 November 2022
File name
Tegsedi SPC IE (Nov 2022).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 November 2022
File name
Tegsedi PIL IE (Nov 2022).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
File name
Tegsedi_Patient_Alert_Card_Ireland_updateSept21 - revised 190722 - Approved version.pdf
Reasons for updating
- Add New Doc
Updated on 01 September 2022
File name
Tegsedi SPC NI and IE (Aug2022).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 April 2022
File name
Tegsedi PL NI and IE (Oct 2021).pdf
Reasons for updating
- New PIL for new product
Updated on 01 April 2022
File name
Tegsedi SPC NI and IE (Nov 2021).pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 December 2021
File name
Tegsedi SPC NI (Nov2021).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)