Tecfidera 120mg and 240mg gastro-resistant hard capsules
*Company:
Biogen Idec (Ireland) LtdStatus:
No Recent UpdateLegal 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 15 October 2024
File name
IE-NI updated Tecfidera PIL ESTEEM cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 October 2024
File name
IE-NI updated Tecfidera SmPC ESTEEM cl.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 March 2024
File name
IE-NI updated Leaflet Tecfidera Cyprus phone number update.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
Updated on 06 December 2023
File name
IE-NI Leaflet Tecgistry.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
Updated on 06 December 2023
File name
IE-NI SPC Tecgistry.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 29 September 2023
File name
IE NI updated PIL Tecfidera renewal.pdf
Reasons for updating
- XPIL Updated
Updated on 29 September 2023
File name
IE NI updated PIL Tecfidera renewal.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 29 September 2023
File name
IE NI updated SPC Tecfidera renewal.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 27 May 2022
File name
Tecfidera-SmPC-pdf.pdf
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 27 May 2022
File name
Tecfidera-PIL-pdf.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 23 February 2022
File name
IE-NI SmPC.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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
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
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 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
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
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
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
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)