Xeljanz 1mg/ml Oral solution
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 21 August 2024
File name
ADV SPC XJ 10_0 OS 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 10_0 OS 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 04 January 2024
File name
ADV PIL XJ 9_0 OS_IE NIclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 18 October 2023
File name
ADV SPC XJ 90 OS 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 80 OS IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 14 March 2023
File name
ADVSPC XJ 8_0 1mg OS 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 7_0 1mg OS 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 6_0 OS 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 7_0 OS 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 5_0 OS 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 6_0 OS 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 50 OS 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 SPC XJ 50 OS IE clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2022
File name
ADVSPCXJ40OSIEclean.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 19 May 2022
File name
ADVSPCXJ40OSIEclean.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 16 May 2022
File name
ADVPILXJ40OSIENIclean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 April 2022
File name
ADVSPCXJ30OSIEclean.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
ADVPILXJ40OSIENIclean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Updated on 28 February 2022
File name
ADV SPC XJ 2_0 OS 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
Update of section 4.4 of the SmPC paragraph on VTE
File name
XeljanzRMPPrescriberMaintenanceChecklistPad.pdf
Reasons for updating
- Add New Doc
File name
PfizerXeljanzRMPPrescriberInitiationChecklistPad.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 09 November 2021
File name
ADV SPC XJ_2_0 OS _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 20 October 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
Please note the RMP / EU annex IID of the product information is updated based on the submission of the final report on Biospecimen testing study, listed as a category 3 study in the RMP. This is an exploratory study to assess biomarkers related to VTE events in Study A3921133. aRMMs will need to be reviewed vs this update.
Updated on 20 October 2021
File name
ADV PIL XJ 2_0 OS 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
Updated on 27 August 2021
File name
DEC202158144_ADV SPC XJ 1_0 OS IE.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 for Xeljanz oral solution 1 mg/ mL
Updated on 27 August 2021
File name
DEC202158144_ADV PIL XJ 1_0 OS IE.pdf
Reasons for updating
- New PIL for new product