Jyseleca

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filgotinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Jyseleca is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease in which the immune system (the body’s natural defences) attacks healthy tissue causing inflammation and pain in joints.

Jyseleca is used alone or with another medicine, methotrexate, after treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or causes unacceptable side effects. DMARDs are medicines, such as methotrexate, that slow down worsening of the disease.

Jyseleca is also used to treat adults with moderately to severely active ulcerative colitis, a condition in which the immune system attacks healthy tissue in parts of the intestine, causing periodical inflammation leading to sores and bleeding.

In this case, Jyseleca is given to patients for whom conventional or biological therapies have not worked well enough, have stopped working or are not tolerated.

Jyseleca contains the active substance filgotinib.

This EPAR was last updated on 09/11/2022

Authorisation details

Product details
Name
Jyseleca
Agency product number
EMEA/H/C/005113
Active substance
filgotinib maleate
International non-proprietary name (INN) or common name
filgotinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
  • Gilead Sciences Ireland UC
  • Galapagos NV
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
24/09/2020
Contact address
  • Carrigtohill
    County Cork T45 DP77
    Ireland

  • Generaal De Wittelaan L11 A3  
    2800 Mechelen
    Belgium

Product information

29/09/2022 Jyseleca - EMEA/H/C/005113 - II/0018

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis
Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).

Ulcerative colitis
Jyseleca is indicated 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.

Assessment history

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