XELJANZ 11 mg prolonged-release 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 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
File name
XeljanzRMPPrescriberMaintenanceChecklistPad.pdf
Reasons for updating
- Add New Doc
File name
PfizerXeljanzRMPPatientAlertCard.pdf
Reasons for updating
- Add New Doc
File name
PfizerXeljanzRMPPrescriberBrochure.pdf
Reasons for updating
- Add New Doc
File name
PfizerXeljanzRMPPrescriberInitiationChecklistPad.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.
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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