Spinraza 12 mg solution for injection
*Company:
Biogen Idec 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
Updated on 25 October 2023
File name
IE-NI SmPC.pdf
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 not be renewed (A)
Updated on 25 October 2023
File name
IE-NI SmPC.pdf
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 not be renewed (A)
Updated on 15 February 2022
File name
Spinraza PIL renewal.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Removal of Black Inverted Triangle
Updated on 15 February 2022
File name
Spinraza SmPC renewal.pdf
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 December 2021
File name
Spinraza SmPC RWE I-NI.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Information added in section 5.1 to include data from Real World Evidence
Updated on 25 February 2021
File name
Spinraza PIL_UK_IRL_Jan_ 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 10 February 2021
File name
UK & IE_Spinraza_SmPC_Jan_2021.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 not be renewed (A)
Updated on 31 January 2020
File name
Spinraza PIL_UK_IRL_Jan_ 2020.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to improve clarity and readability
Free text change information supplied by the pharmaceutical company
There is no content impact to the SmPC. This change was triggered by Biogen’s proposal to extend the duration of the NURTURE study (update to Annex II of the Product Information and the Table 18 of the EU RMP). QRD template changes made ( formatting only).
Updated on 31 January 2020
File name
Spinraza SmPC_UK_IRL_Jan_2020.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
There is no content impact to the SmPC. This change was triggered by Biogen’s proposal to extend the duration of the NURTURE study (update to Annex II of the Product Information and the Table 18 of the EU RMP). QRD template changes made ( formatting only).
Updated on 06 September 2019
File name
SPINRAZA SmPC GBR_IRL_23Aug2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC: Section 4.8 “Post-marketing experience”
Adverse reactions have been identified during post-approval use of Spinraza. Among patients treated with Spinraza by lumbar puncture, serious infection, such as meningitis, has been observed. Communicating hydrocephalus, and aseptic meningitis and hypersensitivity (e.g. angioedema, urticaria and rash) have also been reported. The frequency of these reactions is not known as they have been reported from the post marketing setting.
Updated on 06 September 2019
File name
SPINRAZA PIL_GBR_IRL_23Aug2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Package Leaflet: Section 4 Possible side effects:
Hypersensitivity (an allergic or allergic-like reaction that may include swelling of your face, lips or tongue, rash, or itching)
Updated on 26 June 2019
File name
Spinraza SmPC_UK&IRL_May 2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8: Update to patient numbers and immunogenicity section
5.1: Clinical efficacy with the final clinical data from studies CS3A and EMBRACE (part 1) and the interim data from studies SHINE (June 2017 data cut) and NURTURE (May 2018 data cut).
Updated on 01 April 2019
File name
Spinraza PIL_UK&IRL_March 2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 01 April 2019
File name
Spinraza SmPC_UK&IRL_March 2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8: Aseptic meningitis has been added to the description of undesirable effects under "post-marketing experience".
Updated on 22 November 2018
File name
Spinraza PIL_UK&IRL_Nov 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 22 November 2018
File name
Spinraza SmPC_UK&IRL_Nov 2018.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of MAH to Biogen Netherlands B.V.
Updated on 04 September 2018
File name
Spinraza PIL_UK&IRL_Aug 2018.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 04 September 2018
File name
Spinraza SmPC_UK&IRL_Aug 2018.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.2 (Posology & method of administration) - intrathecal use by lumbar puncture, sentence moved from 'method of administration' to 'Posology' subheading
- Section 4.4 (Special warnings and precautions for use) - paragraph on communicating hydrocephalus added
- Section 4.8 (Undesirable effects) - paragraph on 'post-marketing experience' revised to reflect communicating hydrocephalus
Updated on 16 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Addition of information relating to post-marketing experience
Post-marketing experience
Adverse reactions have been identified during post-approval use of Spinraza. Among patients treated with Spinraza, complications associated with lumbar puncture including serious infection, such as meningitis, have been observed. The frequency of these reactions is not known as they have been reported from the post marketing setting
Section 5.1 - Addition of ATC code
Updated on 08 November 2017
File name
PIL_17183_591.pdf
Reasons for updating
- New PIL for new product
Updated on 08 November 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 June 2017
Reasons for updating
- New PIL for new product