Tecfidera 120mg and 240mg gastro-resistant hard capsules *
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):

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

Updated on 23 February 2022

File name

IE-NI SmPC_1645626909.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update section 4.4 and 5.1 due adding data from ENDORSE clinical study.

Update section 4.8 to add AE Rhinorrhoea with unknown frequency.

Updated on 23 February 2022

File name

IE-NI Leaflet_1645626512.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 January 2022

File name

IE-NI Leaflet PSUR update_1642671051.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

Update to section 4 to include alopecia as common adverse reaction

Updated on 20 January 2022

File name

IE-NI SmPC PSUR update_1642670633.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

Update to section 4.8 to include alopecia as a common adverse reaction and remove footnotes from the table.

Updated on 25 February 2021

File name

Tecfidera PIL_Feb_2021_IE_1614290215.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 08 December 2020

File name

Tecfidera PIL Nov 2020 GB-IE_1607436190.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 08 December 2020

File name

Tecfidera SmPC Nov 2020 GB-IE_1607436041.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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)

Updated on 24 January 2020

File name

Tecfidera SmPC_UK_IRL_Jan_2020_1579858898.pdf

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

Fanconi Syndrome added to section 4.4.

Updated on 24 January 2020

File name

Tecfidera PIL_UK_IRL_Jan_ 2020_1579858553.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Fanconi Syndrome added to section 2.

Updated on 12 December 2019

File name

Tecfidera PIL_UK_IRL_Nov 2019_1576149663.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL : Section 2 Warnings and Precautions

Addition of herpes zoster and guidance for patients

PIL : Section 4 Possible side effects

Addition of herpes zoster with signs and symptoms

Updated on 12 December 2019

File name

Tecfidera SmPC_UK_IRL_Nov 2019_1576149397.pdf

Reasons for updating

  • 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

SmPC : Section 4.4 Special warnings and precautions for use

Inclusion of a paragraph on Herpes Zoster

SmPC : Section 4.8 Undesirable effects

Addition of “Herpes Zoster” to the tabulated summary of adverse events

Addition of a paragraph on Infections – specifically on the incidence of herpes zoster in clinical trials, post marketing setting and lymphopenia status, where known, in patients with herpes zoster

Updated on 21 August 2019

File name

Tecfidera PIL_UK_IRL_July 2019_1566389535.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 21 August 2019

File name

Tecfidera SmPC_UK_IRL_July 2019_1566390478.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 sections 4.8 and 5.1 of the SmPC in order to add the efficacy and safety information based on final results from study 109MS311, a multicentre extension study to determine the long-term safety and efficacy in paediatric subjects with RRMS.

Updated on 08 April 2019

File name

Tecfidera SmPC_UK_IRL_Feb 2019_1554737828.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 to section 5.1 (ATC code):

Pharmacotherapeutic group: Other nervous system drugs Antineoplastic and immunomodulating agents,

ATC code: N07XX09 L04AX07

 

Updated on 28 November 2018

File name

Tecfidera PIL_UK&IRL_Nov 2018_1543393978.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 28 November 2018

File name

Tecfidera_SmPC_UK_IRL_Nov 2018_1543393544.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 8 - Marketing authorisation number(s)
  • 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

  • Thrombocytopenia added as an 'uncommon' adverse reaction to table in section 4.8
  • MAH updated to Biogen Netherlands

 

Updated on 09 October 2018

File name

Tecfidera PIL_UK&IRL_Sept 2018_1539097135.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects

Updated on 09 October 2018

File name

Tecfidera_SmPC_UK_IRL_Sept 2018_1539097368.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the 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

 

  • Section 4.2 Posology and method of administration: Information on what a patient should do if they miss a dose (brought in line with package leaflet), and advise that the capsule should be swallowed whole.
  • Section 4.4 Special warnings and precautions for use: Rewriting and reordering of text on Infections to give clear recommendation to the prescriber, New subheading for treatment initiation.
  • Section 4.5 Interaction with other medicinal products and other forms of interaction: Recommendation that strong alcoholic drinks should be avoided within an hour of taking Tecfidera in line with package leaflet.
  • Section 4.7 Effects on ability to drive and use machines: Addition of standard statements to show Tecfidera has no or negligible influence on the ability to drive and use machines.
  • Section 4.8 Adverse effects: Deletion of renal text.
  • Throughout: Editorial changes in line with SmPC guideline or at the request of the EMA labelling administrative group as part of the Tecfidera 5 year renewal.

Updated on 22 May 2018

File name

Tecfidera_SmPC_UK_IRL_Feb2018.docx

Reasons for updating

  • New SPC for new product

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

Updated on 03 May 2018

File name

Tecfidera_SmPC_UK_IRL_Feb2018.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

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

Updated on 24 April 2018

File name

Tecfidera PIL_UK&IRL_Feb 2018.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 24 April 2018

File name

Tecfidera PIL_UK&IRL_Feb 2018.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 28 March 2018

File name

PIL_15989_910.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 March 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 04 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 04 December 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Addition of information relating to a paediatric PK study of Tecfidera.

Updated on 03 July 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Addition of information relating to impacts on hepatic function.

Updated on 14 June 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 25 January 2017

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Updated details of animal toxicity studies added.

Updated on 18 August 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.8 updated to include information relating to PML in moderate lymphopaenia.

Section 4.5 updated to include information about the use of Tecfidera with oral contraceptives.

Section 4.9 addition of information relating to overdose with Tecfidera.

Updated on 17 August 2016

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions

Updated on 29 June 2016

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

240mg presentation shelf life extended to 4 years.

Updated on 06 January 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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

Multiple sections affected due to combining 120mg and 240mg presentations into a single SmPC.

Information incorporated into sections 4.4 and 4.8 regarding the risk of PML.

Updated on 04 January 2016

Reasons for updating

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

Updated on 11 December 2014

Reasons for updating

  • 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

There is no change to the content of this document beyond the update of date of last revision of the text to 10/2014. This is in line with the date for the SmPC for the 240mg capsules and the Package Leaflet, which have had changes to their content.

Updated on 11 December 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 26 August 2014

Reasons for updating

  • Removal of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

  • The EMA has indicated that TECFIDERA does not need to be included in the list of products subject to additional monitoring, therefore the black triangle designation has been removed from TECFIDERA product information
  • The opportunity has also been taken to change the contact information for IMB to HPRA in Section 4.8, following the change of name of this organisation on July 1st 2014
  • As a result, the date of last revision of the SmPC text in Section 10 has been updated

Updated on 26 August 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Removal of black triangle

Updated on 17 April 2014

Reasons for updating

  • New PIL for new product

Updated on 16 April 2014

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