Xeljanz 5mg film coated tablets
*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 18 October 2023
File name
ADV SPC XJ 510 MG FCT 260 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 18 October 2023
File name
ADV PIL XJ FCT 260 IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 14 March 2023
File name
ADVSPC XJ 5 10MG FCT 25_0 IEclean.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
- Change to section 4.8 - Undesirable effects
- 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 Xeljanz SmPC is being revised based on the Article 20 EC decision received from the EMA for Janus Kinase inhibitors on 13 Mar 2023.
Section 4.4 (Special warnings and precautions for use) and 5.1 (Pharmacodynamic properties) of the Xeljanz SmPC are being updated with regards to MACE according to history of ASCVD.
Impacted sections:
SmPC
Sections 4.2 Posology and method of administration
Section 4.4 Special warnings and precautions for use
Section 4.8 Undesirable effects
Section 5.1 Pharmacodynamic properties
Updated on 14 March 2023
File name
ADVPIL XJ 5mg 10 mg FCT 25_0 IENIclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 15 September 2022
File name
ADV PIL XJ FCT 24_0 IE NI clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 15 September 2022
File name
ADV SPC XJ 5 10 MG FCT 24_0 IEclean.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)
Updated on 22 July 2022
File name
ADV PIL XJ FCT 23_0 IE NI 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 22 July 2022
File name
ADV SPC XJ 5 10 MG FCT 23_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2022
File name
ADVSPCXJ210IEclean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 01 July 2022
File name
ADV PIL XJ FCT 22_0 IE NI clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 19 May 2022
File name
ADVSPCXJ210IEclean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2022
File name
ADVSPCXJ200IEclean.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
- 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 5.2 - Pharmacokinetic 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:
Removal of black triangle statement.
Minor formatting and vocabulary changes sections 4.2, 4.4, 4.5, 4.8, 5.2, 5.2
Updated on 05 April 2022
File name
ADVPILXJFCT210IENIclean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Improved presentation of PIL
File name
PfizerXeljanzRMPPrescriberInitiationChecklistPad.pdf
Reasons for updating
- Add New Doc
File name
XeljanzRMPPrescriberMaintenanceChecklistPad.pdf
Reasons for updating
- Add New Doc
File name
PfizerXeljanzRMPPrescriberBrochure.pdf
Reasons for updating
- Add New Doc
File name
PfizerXeljanzRMPPatientAlertCard.pdf
Reasons for updating
- Add New Doc
Updated on 24 November 2021
File name
ADV SPC XJ 19_0 IE_ clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- 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:
Section 1: Ankylosing Spondylitis as a new indication
Section 2 Posology updated with Ankylosing Spondylitis
Section 4.8: updated with Ankylosing Spondylitis information and platelets information
Section 5.1 updated with Ankylosing Spondylitis clinical data
Updated on 24 November 2021
File name
ADV PIL XJ FCT 20_0 IE NI_clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 3 - how to take/use
Updated on 09 November 2021
File name
ADV SPC XJ 18_0 IE_clean.pdf
Reasons for updating
- 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:
Update of section 4.4 of the SmPC paragraph on VTE
Updated on 03 November 2021
File name
ADV PIL XJ 19_0 IE NI_clean.pdf
Reasons for updating
- Change to other sources of information section
Updated on 27 August 2021
File name
DEC202158144_ADV SPC XJ 17_0 IE clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC has been updated as follows:
· SPC sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 5.3 updated with new Indication for Polyarticular Course Juvenile Idiopathic Arthritis (pJIA) and to allow for once daily dosing of psoriatic arthritis (PsA) as alternative treatment to the currently approved twice daily dosing
· New SPC for Xeljanz oral solution 1 mg/ mL
Updated on 27 August 2021
File name
DEC202158144_ADV PIL XJ 18_0 IE clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
Updated on 23 August 2021
File name
DEC202156612_ADV SPC XJ 16_0 IE_CLEAN.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 following changes to the labeling have been approved. Please refer to attached copy/copies of labeling documentation for full details.
|
Updated on 23 August 2021
File name
DEC202156612_ADV PIL XJ 17_0 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
Updated on 23 August 2021
File name
DEC202156612_ADV PIL XJ 17_0 IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
Updated on 20 January 2021
File name
DEC202103950_ADV SPC XJ 15_0 IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2020
File name
DEC202077751_ADV SPC XJ 14_0 IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2020
File name
DEC202077751_ADV PIL XJ 16_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 09 October 2020
File name
ADV SPC XJ 13_0 IE clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
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 6.1 (List of excipients) of the Xeljanz (tofacitinib) SmPC is being revised to remove the E number (E1518) for the excipient triacetin. |
Updated on 09 October 2020
File name
ADV PIL XJ 15_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 05 February 2020
File name
DEC202005387_ADV PIL XJ 13_0 UK IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 05 February 2020
File name
DEC202005387_ADV SPC XJ 12_0 UK IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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: sections 2, 4.2, 4.3, 4.4, 4.8, 5.1, 5.2, updated in line with PRAC recommendations:
Section 4.2 Maintenance treatment section added
Section 4.3 deleted contraindications for 10 mg twice daily
Section 4.4 VTE section added and further information for patients >65yrs, PE section deleted
Section 4.8 Venous thromboembolism added, further information on VTE
Updated on 19 December 2019
File name
DEC201971659_ADV SPC XJ 11_0 UK IE-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
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 posology updated and section 4.8 side effects table updated and 5.2 Biotransformation and elimination sub heading section updated
Updated on 19 December 2019
File name
DEC201971659_ADV PIL XJ 11_0 UK IE clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 03 July 2019
File name
DEC201933946_ADV PIL XJ 10_0 UK IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 02 July 2019
File name
DEC201933946_ADV SPC XJ 10_0 UK IE clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 November 2018
File name
ADV PIL XJ 9_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 November 2018
File name
ADV SPC XJ 9_0 UK IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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: SPC section 7 Marketing Authorisation Holder change to Pfizer EEIG and section 10 date of revision
Updated on 03 September 2018
File name
ADV PIL XJ 8_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 03 September 2018
File name
ADV SPC XJ 8_0 UK 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: addition of 112 pack size, and corrections SPC section 5.1 Octave Open study data
Updated on 02 August 2018
File name
ADV PIL XJ UK IE 7_0 clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Introduction of new strength
Updated on 02 August 2018
File name
ADV SPC XJ 7_0 UK IE clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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: Sections 1, 2 1,2,3,4.1,4.2,4.4, 4.5-4.9, 5.1-5.3, 6.1, 6.5, 8 and 10, for changes to introduce 10mg presentation and indication for ulcerative colitis
Updated on 31 July 2018
File name
ADV SPC XJ 6_0 UK IE clean 0008.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Update to Sections 4.4, and 5.1 following submission of final CSR for A3921187. Summaries of the design and results of study A3921187 have been integrated into the text and tables of the ‘Clinical efficacy and safety’ sub-section of section 5.1 of the SmPC. Proposed labelling for increased risk of infections with corticosteroids has been included in the SmPC section 4.4.
Updated on 27 July 2018
File name
ADV PIL XJ UK IE 6_0 clean 0008.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 29 June 2018
File name
Adv_SPC_XJ_5_0_UK_IE_clean.docx
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 6.1 - List of excipients
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: Sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.1 to reflect changes resulting from indication extension to treatment of patients with PsA. Change in line with CDS
Updated on 29 June 2018
File name
ADV PIL XJ UK IE 5_0 clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 29 May 2018
File name
ADV_SPC_XJ_4_0_UK_IE_clean.docx
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 to updated SPC Sections 4.4 and 4.8 to include angioedema and hypersensitivity wording.
Updated on 29 May 2018
File name
ADV PIL XJ UK IE 4_0 clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2018
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 January 2018
File name
PIL_17169_290.pdf
Reasons for updating
- New PIL for new product
Updated on 12 January 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 November 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Confirmation has been received today that Xeljanz is now commercially available from 1/11/17. Current approved SPC and PIL are reattached
Updated on 01 November 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 02 June 2017
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 31 May 2017
Reasons for updating
- New PIL for medicines.ie