Spinraza 12 mg solution for injection *
Pharmacy Only: Prescription

  • Company:

    Biogen Idec Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 21 December 2021

File name

Spinraza SmPC RWE I-NI_1640078279.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_1580471146.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_1612948469.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_1580471146.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_1580470881.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_1567780683.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_1567780495.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_1561561972.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_1554123287.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_1554123411.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_1542878365.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_1542878466.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_1536064181.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_1536064480.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

None provided

Updated on 12 June 2017

Reasons for updating

  • New PIL for new product