Enbrel 10 mg powder and solvent for solution for injection for paediatric use

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 02 June 2021

File name

DEC202136258_Adv SPC EN 33_0 10mg Paediatric IE clean_1622609404.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 32_0 10mg Paediatric IE clean_1617131056.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 30_0 10mg Paediatric IE clean_1617130935.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 31_0 10mg Paediatric IE clean_1611648455.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 29_0 10mg Paediatric IE clean_1611648348.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 24 September 2020

File name

DEC202060602_Adv SPC EN 30_0 10mg Paediatric IE clean_1600945637.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 28_0 10mg Paediatric IE clean_1600070506.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 28_0 10mg Paediatric UK_IE clean_1593770569.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 26_0 10mg Paediatric UK_IE clean_1593770497.pdf

Reasons for updating

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

Updated on 03 July 2020

File name

DEC202045193_Adv SPC EN 28_0 10mg Paediatric UK_IE clean_1593770427.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 PIL EN 25_0 10mg Paediatric UK_IE clean_1574756091.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 24_0 10mg Paediatric UK_IE_1556006675.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 26_0 10mg Paediatric UK_IE_1556006723.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 01 March 2019

File name

Adv PIL EN 23_0 10mg Paediatric UK_IE clean_1551379479.pdf

Reasons for updating

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

Updated on 28 February 2019

File name

Adv SPC EN 25_0 10mg Paediatric UK_IE clean_1551379076.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

Section 4.6 addition of most up-to-date information on the safe and effective use of etanercept during pregnancy.

Updated on 03 August 2018

File name

Adv PIL EN 22_0 10mg Paediatric UK_IE clean_1533302563.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 24_0 10mg Paediatric UK_IE clean_1533302611.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_23_0_10mg_Paediatric_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)

Updated on 11 May 2018

File name

Adv_SPC_EN_23_0_10mg_Paediatric_UK_IE_clean.docx

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

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 21_0 10mg Paediatric UK_IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 April 2018

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

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

Updated on 06 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 04 April 2018

File name

PIL_15077_307.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 April 2018

Reasons for updating

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

Updated on 28 February 2018

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Enbrel 10 mg solution for injection
Internal revision number only

Updated on 28 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 26 February 2018

File name

PIL_15077_541.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 February 2018

Reasons for updating

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

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 01 February 2018

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.6 - Special precautions for disposal and other handling

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 3 – update to the description of the colour of the solutions. Section 6.6 – update to the description of the colour of the solutions.

Updated on 08 December 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

The frequencies for the ADRs were re-assessed based on a query from a health authority in a PSUR assessment regarding the frequency categories of etanercept ADRs. Due to the reassessment, some ADRs frequencies have been updated and 3 additional are added. Information on 2 ADRs for which there are notable differences observed in the frequencies between the etanercept only and etanercept plus concomitant methotrexate treatment groups is added.

Updated on 05 December 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 09 June 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

Type II Variation update to Section 4.8 ‘Undesirable Effects’ of the SPC in order to change the frequency category of the ADR ‘elevated liver enzymes’ from ‘rare’ to ‘uncommon’ and to add some further details on the frequency of elevated liver enzymes reported with etanercept in double-blind controlled trials with or without concomitant methotrexate use. The Package Leaflet (Section 4) was updated accordingly.

In addition, Pfizer took the opportunity to update Section 4.4 of the SPC to add a statement on traceability of biological medicinal products as requested by the PRAC, to make a small correction in Section 6 of the 50 mg solution for injection in a pre-filled pen Package Leaflet ( EU / 1 / 99 / 126 / 0019-021), and to bring the PI in line with the latest QRD template version 10 (i.e. include the unique identifiers in sections 17 and 18 of Annex IIIA).

Updated on 07 June 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 27 April 2017

Reasons for updating

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

Updated on 27 April 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

Update to Section 4.8 ‘Undesirable Effects’ of the SPC in order to change the frequency category of the ADR ‘elevated liver enzymes’ from ‘rare’ to ‘uncommon’ and to add some further details on the frequency of elevated liver enzymes reported with etanercept in double-blind controlled trials with or without concomitant methotrexate use. The Package Leaflet (Section 4) was updated accordingly.

In addition, Pfizer took the opportunity to update Section 4.4 of the SPC to add a statement on traceability of biological medicinal products as requested by the PRAC, to make a small correction in Section 6 of the 50 mg solution for injection in a pre-filled pen Package Leaflet ( EU / 1 / 99 / 126 / 0019-021), and to bring the PI in line with the latest QRD template version 10

Updated on 10 May 2016

Reasons for updating

  • 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

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:

EU EN 043 is an update to Section 5.1 of the SmPC to add efficacy and safety information to reflect the final 2-year data from study B181031 (non-radiographic axial spondyloarthritis study).

EU EN 051 updates to Section 4.4 of the SmPC to include information on new onset congestive heart failure (CHF), including CHF in patients without known pre-existing cardiovascular disease, and Section 4.8 to amend the term ‘worsening of congestive heart failure’ to ‘congestive heart failure’

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 24 December 2015

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 of the SmPC and Section 2 of the PIL have been updated to include the information on the effects of etanercept on pregnancy to reflect the final report of the OTIS registry.

Updated on 18 December 2015

Reasons for updating

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

Updated on 26 June 2015

Reasons for updating

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

Updated on 24 April 2015

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

The SPC has been updated as follows: The  10-year efficacy data in rheumatoid arthritis (RA) has been added  in the clinical trials section 5.1 of the Summary of Product Characteristics (SmPC).

Updated on 27 October 2014

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

Update section 4.8 SmPC to align with CDS to introduce viral infections in the list of opportunistic infections.

Updated on 11 August 2014

Reasons for updating

  • 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

Update to sections 4.8 & 10

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 30 October 2013

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

Update to sections 4.4 & 4.8

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 28 August 2013

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

Update to section 4.6, Fertility, pregnancy and lactation to add information regarding the placental transfer of etanercept. Enhanced instructions for preparing for an injection using the pre-filled syringe presentations following the introduction of a new packaging design, referred to as a slim-pack design have been added. Minor changes to align with EMA Product Information (PI) QRD templates have also been introduced.

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 02 July 2013

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Update to the description of the liquid solution in the Enbrel pre-filled syringe (PFS) and pre-filled pen (PFP) presentations.

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 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

Section 4.6 of the SPC has been updated regarding lactation information

Updated on 26 March 2013

Reasons for updating

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

Updated on 24 January 2013

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

Update to section 4.8

Updated on 17 January 2013

Reasons for updating

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

Updated on 12 November 2012

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

Add scleritis as an adverse drug reaction to section 4.8 of the SPC

Updated on 06 November 2012

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 13 September 2012

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

Update to sections 4.4 & 4.8  to supplement the infections information in the special warnings and AE sections regarding listeria, legionella, and parasitic infection, including protozoal infections.

Updated on 13 August 2012

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Sections 4.1 - 4.5, 4.8, 5.1, 5.2, 10: Extension the indication for juvenile idiopathic arthritis (JIA) to include three new subtypes of the disease and to include long-term safety information for the JIA population, together with reclassification of the licensed indication of polyarticular JIA into the International League of Associations for Rheumatology (ILAR) classification of polyarthritis (rheumatoid factor positive) and polyarthritis (rheumatoid factor negative). Furthermore, an additional etanercept dosage regimen of 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly is proposed in addition to the current approved JIA dosage of 0.4 mg/kg (up to a maximum of 25 mg per dose) twice weekly for the treatment of JIA

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 29 September 2011

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 4.1:    Extension of polyarticular JIA population to include 2 & 3 year olds. Extension of paediatric psoriasis to include 6 & 7 year olds.
Section 4.2:    Update to paediatric population information.
Section 5.1:    Update to Clinical efficacy and safety information. Update to paediatric population information.
Section 6.3:     Update to shelf life information
Section 6.4:     Update to storage information

Updated on 23 September 2011

Reasons for updating

  • Changes to therapeutic indications

Updated on 25 August 2011

Reasons for updating

  • New SPC for medicines.ie

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 23 August 2011

Reasons for updating

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

Updated on 21 July 2011

Reasons for updating

  • New PIL for medicines.ie