Fampyra 10 mg prolonged-release tablets

  • Name:

    Fampyra 10 mg prolonged-release tablets

  • Company:
    info
  • Active Ingredients:

    Fampridine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 15/8/2018

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Biogen Idec Ltd

Biogen Idec Ltd

Company Products

Medicine NameActive 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 Benepali 25mg solution for injection in pre-filled syringe Active Ingredients Etanercept
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 26 November 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Deletion of Biogen (Denmark) Manufacturing ApS as site responsible for the manufacture of the finished product.

Updated on 15 August 2018 PIL

Reasons for updating

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

Updated on 15 August 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

Change in MAH to Biogen Netherlands B.V.

Updated on 10 July 2018 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

The following undesirable effects have been added to the SmPC (with corresponding updates to section 4.4):

  • Influenza (common)
  • Nasopharyngitis (common)
  • Viral infection (common)

Updated on 10 July 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 June 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 26 June 2017 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company

Multiple changes associated with change from 'conditional' to 'standard' marketing authorization.

Updated on 14 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Removal of black triangle

Updated on 28 June 2016 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • 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

Updated to reflect renewal date.

Updated on 28 June 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 23 June 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 12 April 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 27 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 20 October 2015 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • 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

Updates to sections 9 & 10 following renewal.

Updated on 6 November 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 26 August 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • 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

  • In Section 4.8, exacerbation of trigeminal neuralgia has been included as an uncommon side effect
  • The opportunity has also been taken to update the contact details for IMB to HPRA, following the change of name of this organisation on July 1st 2014
  • In Section 9, the date of latest renewal of the MA has been included
  • In Section 10, the date of last revision of the SmPC text has been updated accordingly

Updated on 26 August 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 17 June 2014 SmPC

Reasons for updating

  • 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

In Section 4.4, the wording relating to the risk of falls has been updated as follows:

 

The increased incidence of dizziness and balance disorder seen with Fampyra in the first 4 to 8 weeks of treatment may result in an increased risk of falls. Therefore, Ppatients who are using should use walking aids should continue to use these aids as needed.

Updated on 17 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 17 July 2013 SmPC

Reasons for updating

  • Addition of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

In Section 4.4, a warning to pay particular attention to patients with a history of allergic reactions has been added
In Section 4.8, reports of serious hypersensitivity reactions have been added
The date of last revision of the text has been updated to 05/2013

Updated on 17 July 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of black triangle

Updated on 27 June 2012 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Latest renewal date text removed. (section 9)

Updated on 6 June 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • 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

In section 6.5 (Nature and contents of container)- Blister packs have been added
In section 8 (Marketing authorisation number)- Additonal MA numbers for blister packs are now inclueded
In section 9 (Date of first authorisation./renewal of authorisation)- Renewal date added
In section 10 (Date of revision of text)- Date amended

Updated on 30 May 2012 PIL

Reasons for updating

  • Change to packaging
  • Change to date of revision
  • Change of distributor details

Updated on 4 October 2011 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 22 September 2011 PIL

Reasons for updating

  • New PIL for new product