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XELJANZ 11 mg prolonged-release tablets

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Pharmacy Only: Prescription

Updated on 22 August 2024

File name

ADV PIL XJ 11mg PR 15_0 IE NI_clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 August 2024

File name

ADV SPC XJ 11mg PR 15_0 IE_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Updated inline with QRD template and/or excipient guideline

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 PML to section 4.4.

Section 5.1 is updated to revise the ATC code.

Revisions to SPC to align with QRD template 10.4.


Updated on 21 August 2024

File name

ADV PIL XJ 11mg PR 14_0 IE NI_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 18 October 2023

File name

ADV SPC XJ 11mg PR 140 IEclean.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 11mg PR 130 IE NI clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 March 2023

File name

ADVSPC XJ 11mg PR 13_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 11mg PR 12_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 11 mg PR 11_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 11 mg PR 12_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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 July 2022

File name

ADV PIL XJ 11mg PR 10_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 11mg PR 11_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

ADV SPC XJ 11mg PR 10_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 4.8 - 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 11mg PR 9_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

ADVSPCXJ11mgPR090IEclean.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

ADVSPCXJ11mgPR080IEclean.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

ADVPILXJ11mgPR80IENIclean.pdf

Reasons for updating

  • Removal of Black Inverted Triangle
  • Improved presentation of PIL

EDM Updated on 18 February 2022

File name

XeljanzRMPPrescriberMaintenanceChecklistPad.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 18 February 2022

File name

PfizerXeljanzRMPPrescriberInitiationChecklistPad.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 18 February 2022

File name

PfizerXeljanzRMPPrescriberBrochure.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 18 February 2022

File name

PfizerXeljanzRMPPatientAlertCard.pdf

Reasons for updating

  • Add New Doc

Updated on 03 November 2021

File name

ADV PIL XJ 11mg PR 7_0 IE NI_clean.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 26 October 2021

File name

ADV SPC XJ 11mg PR 07_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 27 August 2021

File name

DEC202158144_ADV SPC XJ 11mg PR 06_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 11mg PR 6_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 11mg PR 05_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.

The SPC has been updated as follows:

 

4.4       Special warnings and precautions for use:

·         Information on “Use in patients over 65 years of age” added

·         Additional information on Major adverse cardiovascular events (MACE)

·         Additional information on Malignancy and lymphoproliferative disorder

4.8       Undesirable effects:

·         Additional information on Neoplasms benign, malignant and unspecified: Lung cancer; lymphoma

·         Cardiac disorders: Myocardial infarction

 

5.1       Pharmacodynamic properties:

·         Additional clinical data on MACE

·         Additional clinical data on Malignancies

 

Updated on 23 August 2021

File name

DEC202156612_ADV PIL XJ 11mg PR 6_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 24 November 2020

File name

DEC202077751_ADV SPC XJ 11mg PR 04_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 11mg PR 4_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 11mg PR 03_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 11mg PR 3_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 26 June 2020

File name

DEC202041151_ADV SPC XJ 11mg PR 02_0 UKIE- clean.pdf

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

New SPC to reflect the new Pfizer Marketing Authorisation

Updated on 26 June 2020

File name

DEC202041151_ADV PIL XJ 11mg PR 02_0 UK IE clean.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL to reflect the new Pfizer Marketing Authorisation