Enbrel 25 mg solution for injection in pre-filled pen
*Company:
Pfizer Healthcare IrelandStatus:
UpdatedLegal 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 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 20_0 25mg 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
AdvPILEN19125mgPenIENIclean.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 18_0 25mg 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
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
AdvPILEN19025mgPenIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 November 2023
File name
AdvPILEN19025mgPenIENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 October 2023
File name
Adv PIL EN 18_0 25mg 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 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 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 170 25mg 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 16_0 25 mg 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 15_0 25 mg 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 14_0 25 mg 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 13_0 25 mg 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 11_0 25 mg 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
Adv PIL EN 10_0 25 mg Pen UK_IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- 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 23 April 2019
File name
DEC201920929_Adv PIL EN 9_0 25 mg 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 13 March 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 8_0 25 mg 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 7_0 25 mg 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 01 June 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 6_0 25 mg Pen UK_IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 04 April 2018
File name
PIL_17309_942.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 26 February 2018
File name
PIL_17309_689.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 25 September 2017
Reasons for updating
- New PIL for new product
- New PIL for medicines.ie