Jyseleca 100 mg and 200 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Galapagos Biotech Limited
  • Status:

    No Recent Update
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22 November 2021

File name

Jyseleca IE&XI PIL (November 2021)_1637580892.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)_1637580641.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)_1634824820.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)_1634824409.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_1620394832.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_1620394790.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.

EDM Updated on 10 October 2020

File name

Jyseleca Patient Alert Card (Ireland) UK-INF-2020-08-0020_1602344862.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 10 October 2020

File name

Jyseleca HCP Guide (Ireland) UK-INF-2020-08-0019_1602344862.pdf

Reasons for updating

  • Add New Doc

Updated on 05 October 2020

File name

Jyseleca PIL -Sep 2020_1601905338.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 October 2020

File name

Jyseleca SmPC -Sep 2020_1601905298.pdf

Reasons for updating

  • New SPC for new product

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