Enbrel 10 mg powder and solvent for solution for injection for paediatric use
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 16 April 2024
File name
Adv SPC EN 39_0 10mg Paediatric 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 35_0 10mg Paediatric IE 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
AdvSPCEN38110mgPaediatricIEclean.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
AdvPILEN34110mgPaediatricIENIclean.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 37_0 10mg Paediatric 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 SPC EN 37_0 10mg Paediatric 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 33_0 10mg Paediatric IE NI clean.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 07 November 2023
File name
AdvPILEN34010mgPaediatricIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
AdvPILEN34010mgPaediatricIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
AdvPILEN34010mgPaediatricIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
AdvPILEN34010mgPaediatricIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
AdvPILEN34010mgPaediatricIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
Adv SPC EN 37_0 10mg Paediatric 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
Section 4.8 of the SPC was updated with glomerulonephritis with the frequency >not known<.
Updated on 13 October 2023
File name
Adv PIL EN 33_0 10mg Paediatric 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 12 October 2023
File name
Adv SPC EN 37_0 10mg Paediatric 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 33_0 10mg Paediatric IE 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 360 10mg Paediatric 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)
Updated on 15 August 2023
File name
Adv PIL EN 320 10mg Paediatric IE NI clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to information for healthcare professionals
Updated on 16 January 2023
File name
Adv SPC EN 34_0 10mg Paediatric IE clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 June 2022
File name
AdvSPCEN34010mgPaediatricIEclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
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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 31_0 10mg Paediatric 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 33_0 10mg Paediatric 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 32_0 10mg Paediatric 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 30_0 10mg Paediatric 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 31_0 10mg Paediatric 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 29_0 10mg Paediatric 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 24 September 2020
File name
DEC202060602_Adv SPC EN 30_0 10mg Paediatric 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 28_0 10mg Paediatric 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 28_0 10mg Paediatric UK_IE 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 26_0 10mg Paediatric UK_IE clean.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.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.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.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.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.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.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.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.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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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
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
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
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
Internal revision number only
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
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 4.4 - 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 10Updated on 27 April 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
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)
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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
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)
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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
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
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
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)
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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)
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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
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)
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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)
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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)
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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