Jyseleca
filgotinib
Table of contents
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 ha caused unacceptable side effects. DMARDs are medicines, such as methotrexate, that slow down the worsening of the disease.
- 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.
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.
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List item
Jyseleca : EPAR - Medicine overview (PDF/111.73 KB)
First published: 28/09/2020
Last updated: 27/07/2023
EMA/156822/2023 -
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List item
Jyseleca : EPAR - Risk-management-plan summary (PDF/2.84 MB)
First published: 28/09/2020
Last updated: 27/07/2023
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 |
L04AA45
|
Additional 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 |
|
| Revision |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
24/09/2020
|
| Contact address |
|
Product information
29/05/2023 Jyseleca - EMEA/H/C/005113 - A20/0014
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.