Enbrel 25 mg solution for injection in pre-filled pen * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
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 12 November 2021
File name
Adv PIL EN 16_0 25 mg Pen IE NI clean_1636728292.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_1622609693.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_1617131451.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_1617131386.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_1611648695.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_1611648661.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_1600071129.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_1600071096.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_1593770860.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_1593770819.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_1574771068.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_1574757686.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_1556006787.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_1556006848.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_1552469000.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_1552383195.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_1533302819.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_1533302862.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