Jyseleca 100 mg and 200 mg film-coated tablets
*Company:
Alfasigma Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 30 October 2024
File name
Jyseleca UK (Ireland, Malta) PIL approved Oct 24.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Batch release site updated
File name
IE_HCP Guide_Digital_13Sep24.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
MAH transfer from Galapagos to Alfa Sigma
File name
IE_Patient alert card_Digital_11Sep24.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
MAH transfer from Galapagos to Alfa Sigma
Updated on 17 September 2024
File name
Jyseleca UK (Ireland, Malta) 100mg and 200mg SmPC Clean MAH transfer - August 2024 (1).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
MAH updated from Galapagos to Alfa Sigma
Updated on 17 September 2024
File name
Jyseleca UK (Ireland, Malta) PIL MAH Transfer Clean August 2024 (1).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH updated from Galapagos to AlfaSigma
Updated on 10 July 2024
File name
Jyseleca UK (Ireland, Malta) SmPC Bottle Change Clean July 24.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 6.5
Updated on 22 May 2024
File name
Jyseleca UK (Ireland, Malta) SmPC Darwin May 2024.pdf
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- 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
Section 4.7 - Updated
Section 4.8 - Updated
Section 5,1 - Updated with new Darwin 3 Study information
Updated on 22 May 2024
File name
Jyseleca UK (Ireland, Malta) PIL Darwin Approved May 24.pdf
Reasons for updating
- Change to other sources of information section
Updated on 09 January 2024
File name
Jyseleca UK (Ireland, Malta) Clean - SmPC Approved Jan 24 - PSUR.pdf
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- 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
Vertigo added as an adverse event.
Updated on 09 January 2024
File name
Jyseleca UK (Ireland, Malta) Clean - PIL Approved Jan 24 - PSUR.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Vertigo added as an adverse event.
Updated on 31 May 2023
File name
IE SmpC approved May 23.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 3 - details of tablet debossing updated from 'GSI' to 'G'
Updated on 31 May 2023
File name
IE PIL approved May 23.pdf
Reasons for updating
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Section 6 = Details of tablet debossing updated from 'GSI' to 'G'
File name
IE_Jyseleca HCP Guide Risk Management Materials_HCP_March2023.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update due to a variation approval
File name
IE_Patient alert card_Patients_March2023_DIGITAL.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update due to a variation approval
Updated on 13 March 2023
File name
Jyseleca UKNI (Ireland, Malta) SmPC Clean.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 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
Section 4.2 - Section updated, information on maintenance treatment added, Information on elderly patients updated, Information on UC updated,
Section 4.4 - Box warning added - information for aged 65 and older only and associated risks, Malignancy information updated, MACE information updated, VTE information updated,
Section 4.8 - Sepsis added as a new AE
Section 10 - Date of revision updated
Updated on 13 March 2023
File name
Jyseleca UKNI (Ireland, Malta) PIL Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Warnings updated and new section on elderly patients added
Section 3 - Dose information updated and age information updated
Section 4 - Side effects updated - Blood infection added
Section 6 - Date of revision updated
Updated on 21 November 2022
File name
IE NI SmPC Manta for eMC Sept 22.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Male Fertility Warnings Deleted
Updated on 21 November 2022
File name
IE NI PIL Manta for eMC Sept 22.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Section 2 - Warnings and precautions - Male fertility warnings deleted
Updated on 28 October 2022
File name
Jyseleca Combined Shelf Life Extn NI IE MT Approved Sept 22.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Shelf Life updated from 3-4 years.
File name
HCP Guide NI_v4.0_11Mar22 (2).pdf
Reasons for updating
- Replace File
File name
Jyseleca HCP Guide (Ireland) UK-INF-2020-08-0019 (3).pdf
Reasons for updating
- Replace File
Updated on 13 September 2022
File name
Jyseleca PIL XI IE Aug 22.pdf
Reasons for updating
- Change to side-effects
Updated on 19 August 2022
File name
Jyseleca UK (Ireland, Malta) SPC only 062022.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 August 2022
File name
Jyseleca UK (Ireland, Malta) Full Annexes_062022.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 August 2022
File name
Jyseleca UK (Ireland, Malta) Full Annexes_062022.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 February 2022
File name
Jyseleca Ireland Malta NI SmPC.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 November 2021
File name
Jyseleca IE&XI PIL (November 2021).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 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Approval of extension of indication to include use of Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
The variation updates the product information extensively as follows:
• SmPC updates to sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 5.3
• Consequential updates to the Package Leaflet sections 1, 2 and 3
The MAH also took the opportunity to make minor updates to the Annex II and to implement minor editorial changes in the SmPC and Package Leaflet
Updated on 22 November 2021
File name
Jyseleca IE&XI SmPC (November 2021).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
Approval of extension of indication to include use of Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
The variation updates the product information extensively as follows: SmPC updates to sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 5.3
Updated on 21 October 2021
File name
Jyseleca IE&XI PIL (September 2021).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
In line with the changes to SmPC sections 4.5 and 5.2 in order to reflect new pharmacokinetic information on the effect of filgotinib on OATP/CYP3A, OATP/BCRP, and OATP substrates based on final results from study GS-US-417-5937; this is a Phase 1, randomized, two-way crossover, open-label, single and multiple dose, single center study to evaluate the effect of filgotinib on a mixed OATP/CYP3A, OATP/BCRP, and OATP substrates using phenotypic probes; the Package Leaflet is updated accordingly. Update of sections 4.5 and 5.2 of the SmPC in order to reflect new pharmacokinetic information on the effect of filgotinib on OATP/CYP3A, OATP/BCRP, and OATP substrates based on final results from study GS-US-417-5937; this is a Phase 1, randomized, two-way crossover, open-label, single and multiple dose, single center study to evaluate the effect of filgotinib on a mixed OATP/CYP3A, OATP/BCRP, and OATP substrates using phenotypic probes; the Package Leaflet is updated accordingly.
Updated on 21 October 2021
File name
Jyseleca IE&XI SmPC (September 2021).pdf
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)
Updated on 07 May 2021
File name
Jyseleca SmPC - April 2021.pdf
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)
Updated on 07 May 2021
File name
Jyseleca PIL - April 2021.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Addition of information on reporting a side effect.
File name
Jyseleca Patient Alert Card (Ireland) UK-INF-2020-08-0020.pdf
Reasons for updating
- Add New Doc
File name
Jyseleca HCP Guide (Ireland) UK-INF-2020-08-0019.pdf
Reasons for updating
- Add New Doc
Updated on 05 October 2020
File name
Jyseleca PIL -Sep 2020.pdf
Reasons for updating
- New PIL for new product
Updated on 05 October 2020
File name
Jyseleca SmPC -Sep 2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)