Enbrel 10 mg powder and solvent for solution for injection for paediatric use
- Name:
Enbrel 10 mg powder and solvent for solution for injection for paediatric use
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/03/21
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Pfizer Healthcare Ireland
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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 30 March 2021 SPC
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 3 July 2020 SPC
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 3 July 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 3 July 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 26 November 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 April 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 April 2019 SPC
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 1 March 2019 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 28 February 2019 SPC
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 3 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 3 August 2018 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 6 April 2018 SPC
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 6 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 April 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 4 April 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 February 2018 SPC
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 28 February 2018 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 26 February 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - what the product looks like and pack contents
Updated on 5 February 2018 PIL
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 1 February 2018 SPC
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 8 December 2017 SPC
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 5 December 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 9 June 2017 SPC
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 7 June 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 27 April 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 April 2017 SPC
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 10 May 2016 SPC
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 4 May 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 24 December 2015 SPC
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 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 26 June 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 24 April 2015 SPC
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 SPC
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
Updated on 11 August 2014 SPC
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 4 August 2014 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
Updated on 30 October 2013 SPC
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 23 October 2013 PIL
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 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 2 July 2013 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 24 January 2013 SPC
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
Updated on 17 January 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 November 2012 SPC
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
Updated on 6 November 2012 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 13 September 2012 SPC
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 SPC
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 7 August 2012 PIL
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 SPC
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 4.2: 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 PIL
Reasons for updating
- Changes to therapeutic indications
Updated on 25 August 2011 SPC
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
Updated on 23 August 2011 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 21 July 2011 PIL
Reasons for updating
- New PIL for medicines.ie