Spinraza 12 mg solution for injection
- Name:
Spinraza 12 mg solution for injection
- Company:
Biogen Idec Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/01/20
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Spinraza is and what it is used for
1. What Spinraza is and what it is used for
2. What you need to know before you or your child are given Spinraza
2. What you need to know before you or your child are given Spinraza
3. How Spinraza is given
3. How Spinraza is given
4. Possible side effects
4. Possible side effects
5. How to store Spinraza
5. How to store Spinraza
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Biogen Idec Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name AVONEX 30 micrograms/0.5 ml solution for injection | Active Ingredients Interferon beta-1a |
| Medicine Name AVONEX 30 micrograms/0.5ml solution for injection, in pre-filled pen | Active Ingredients Interferon beta-1a |
| Medicine Name Fampyra 10 mg prolonged-release tablets | Active Ingredients Fampridine |
| 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 |
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 31 January 2020 PIL
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 SmPC
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 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
Updated on 12 June 2017 PIL
Reasons for updating
- New PIL for new product