Spinraza 12 mg solution for injection

  • Name:

    Spinraza 12 mg solution for injection

  • Company:
    info
  • Active Ingredients:

    Nusinersen sodium

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/09/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 6/9/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Biogen Idec Ltd

Biogen Idec Ltd

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Medicine Name Benepali 50 mg solution for injection in pre-filled pen Active Ingredients Etanercept
Medicine Name Benepali 50 mg solution for injection in pre-filled syringe Active Ingredients Etanercept
Medicine Name Fampyra 10 mg prolonged-release tablets Active Ingredients Fampridine
Medicine Name Flixabi 100 mg powder for concentrate for solution for infusion Active Ingredients Infliximab
Medicine Name Imraldi 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Imraldi 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Plegridy 63 mcg, 94 mcg and 125mcg solution for injection in pre-filled pen Active Ingredients peginterferon beta-1a
Medicine Name Spinraza 12 mg solution for injection Active Ingredients Nusinersen sodium
Medicine Name Tecfidera 120mg and 240mg gastro-resistant hard capsules Active Ingredients Dimethyl fumarate
Medicine Name Tysabri 300mg concentrate for solution for infusion Active Ingredients Natalizumab
1 - 0 of 13 items.Total: Infinity pages

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 6 September 2019 SmPC

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 6 September 2019 PIL

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 SmPC

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 1 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 1 April 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 22 November 2018 SmPC

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 4 September 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 4 September 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 November 2017 SmPC

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 8 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 November 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 June 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product