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Enbrel 50 mg solution for injection in pre-filled pen

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Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Etanercept

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

Updated on 16 April 2024

File name

Adv SPC EN 45_0 25mg 50mg Pen IE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 16 April 2024

File name

Adv PIL EN 39_0 50mg Pen IENI clean.pdf

Reasons for updating

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

Updated on 20 December 2023

File name

AdvSPCEN44125mg50mgPenIEclean.pdf

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 SPC IE and SPC NI has been updated as follows: 

Section 4.8 of the SPC was updated with glomerulonephritis with the frequency >not known<.


Updated on 20 December 2023

File name

AdvPILEN38150mgPenIENIclean.pdf

Reasons for updating

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

Updated on 09 November 2023

File name

Adv SPC EN 43_0 25mg 50mg Pen IE clean.pdf

Reasons for updating

  • Previous version of SPC reinstated

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

Updated on 09 November 2023

File name

Adv PIL EN 37_0 50mg Pen IE NI clean.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 09 November 2023

File name

Adv PIL EN 37_0 50mg Pen IE NI clean.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 07 November 2023

File name

AdvSPCEN44025mg50mgPenIEclean.pdf

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 of the SPC was updated with glomerulonephritis with the frequency >not known<.

Updated on 07 November 2023

File name

AdvPILEN38050mgPenIENIclean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 October 2023

File name

Adv SPC EN 43_0 25mg50mg Pen IE clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 12 October 2023

File name

Adv PIL EN 37_0 50mg Pen IE NI clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 15 August 2023

File name

Adv SPC EN 420 25mg 50mg Pen IEclean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 15 August 2023

File name

Adv PIL EN 360 50mg Pen IE NI clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to information for healthcare professionals

Updated on 21 June 2022

File name

AdvSPCEN41025mg50mgPenIEclean.pdf

Reasons for updating

  • 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 5.1 with final results obtained from the clinical paediatric study B1801023 (CLIPPER 2).  

Updated on 12 November 2021

File name

Adv PIL EN 34_0 50mg Pen IE NI clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer

Updated on 02 June 2021

File name

DEC202136258_Adv SPC EN 40_0 25mg_50mg Pen IE clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.2 Detailed instructions on unintentional dosing or scheduling variations, including missed doses to refer to the PIL

Updated on 30 March 2021

File name

DEC202121880_Adv SPC EN 39_0 25mg_50mg Pen IE clean.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 30 March 2021

File name

DEC202121880_Adv PIL EN 33_0 50mg Pen IE clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 January 2021

File name

DEC202104817_Adv SPC EN 38_0 25mg_50mg Pen IE clean.pdf

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

The SPC has been updated as follows: Section 4.8 addition of headache as an ADR with a frequency of very common. Section 4.4 and 4.8 removal of text regarding IBD in JIA patients

Updated on 26 January 2021

File name

DEC202104817_Adv PIL EN 32_0 50mg Pen IE clean.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

Updated on 14 September 2020

File name

DEC202060602_Adv SPC EN 37_0 25mg_50mg Pen IE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 14 September 2020

File name

DEC202060602_Adv PIL EN 31_0 50mg Pen IE clean.pdf

Reasons for updating

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

Updated on 03 July 2020

File name

DEC202045193_Adv SPC EN 35_0 25mg_50mg Pen clean.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

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.2 and 4.4 have been updated to refmove the work Alert from Patient Alert Card.

Updated on 03 July 2020

File name

DEC202045193_Adv PIL EN 30_0 50mg Pen UK_IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 26 November 2019

File name

DEC201965747_Adv SPC EN 33_0 25mg_50mg Pen UK_IE clean.pdf

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 SPC has been updated as follows: Section 4.8 Addition of adverse reaction for Inflammatory bowel disease. Package Leaflet:

Updated on 26 November 2019

File name

DEC201965747_Adv PIL EN 28_0 50mg Pen UK_IE clean.pdf

Reasons for updating

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

Updated on 23 April 2019

File name

DEC201920929_Adv PIL EN 27_0 50mg Pen UK_IE.pdf

Reasons for updating

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

Updated on 23 April 2019

File name

DEC201920929_Adv SPC EN 33_0 25mg_50mg Pen UK_IE.pdf

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 SPC has been updated as follows: Section 4.8 addition of PRAC class labelling for Lichenoid Reactions

Updated on 04 April 2019

File name

Adv SPC EN 32_0 25mg_50mg Pen UK_IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.6 addition of most up-to-date information on the safe and effective use of etanercept during pregnancy.

Updated on 12 March 2019

File name

Adv PIL EN 26_0 50mg Pen UK_IE clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 03 August 2018

File name

Adv PIL EN 25_0 50mg Pen UK_IE clean.pdf

Reasons for updating

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

Updated on 03 August 2018

File name

Adv SPC EN 31_0 25mg_50mg Pen UK_IE clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 Name and address of MAH changed from Pfizer UK to Pfizer Belgium.

Updated on 11 May 2018

File name

Adv_SPC_EN_EN_30_0_25mg_50mg_Pen_UK_IE_clean.docx

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

The SPC has been updated as follows: Date of approval, PfLEET number and internal revision number only

Updated on 10 May 2018

File name

Adv PIL EN 25_0 50mg Pen UK_IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 05 April 2018

File name

PIL_14356_865.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 April 2018

Reasons for updating

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

Updated on 26 February 2018

File name

PIL_14356_213.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 February 2018

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number

Updated on 05 February 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 05 December 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 07 June 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 24 April 2017

Reasons for updating

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

Updated on 04 May 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 07 March 2016

Reasons for updating

  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 28 January 2016

Reasons for updating

  • Change to dosage and administration

Updated on 18 December 2015

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 22 October 2015

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 26 June 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 04 August 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 23 October 2013

Reasons for updating

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

Updated on 23 August 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 28 June 2013

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 27 March 2013

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 17 January 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 07 August 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 13 January 2012

Reasons for updating

  • Change to packaging

Updated on 21 October 2011

Reasons for updating

  • Change to storage instructions

Updated on 11 October 2011

Reasons for updating

  • Change to packaging
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 23 September 2011

Reasons for updating

  • Changes to therapeutic indications

Updated on 23 August 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 22 July 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 10 June 2011

Reasons for updating

  • Change to side-effects

Updated on 31 May 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 08 March 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 04 February 2011

Reasons for updating

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

Updated on 16 December 2010

Reasons for updating

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

Updated on 30 July 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 05 July 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to MA holder contact details

Updated on 18 January 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to MA holder contact details

Updated on 02 November 2009

Reasons for updating

  • PIL re-instated

Updated on 05 August 2009

Reasons for updating

  • New PIL for new product
  • PIL retired pending re-submission