Xeljanz
tofacitinib
Table of contents
Overview
Xeljanz is a medicine to treat:
- adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints. Xeljanz is used with another medicine, methotrexate, after treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects. Xeljanz can be taken on its own if patients cannot take methotrexate;
- adults with psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints). Xeljanz is used together with methotrexate after treatment with one or more DMARDs has not worked well enough or has led to troublesome side effects;
- children from two years of age with active polyarticular juvenile idiopathic arthritis (pJIA) or juvenile psoriatic arthritis, a subtype of juvenile idiopathic arthritis (JIA), which is a long-term disease that causes joint pain and inflammation in children. Xeljanz is used after treatment with one or more DMARDs has not worked well enough. Xeljanz can be taken together with methotrexate or on its own if patients cannot take methotrexate;
- adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers (sores) in the lining of the gut, after treatment with other medicines has not worked well, has stopped working or has led to troublesome side effects;
- adults with ankylosing spondylitis, a disease that causes inflammation of the joints of the spine, after treatment with other medicines has not worked well enough.
Xeljanz contains the active substance tofacitinib.
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List item
Xeljanz : EPAR - Medicine overview (PDF/142.78 KB)
First published: 31/03/2017
Last updated: 14/12/2021
EMA/687021/2019 -
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Xeljanz : EPAR - Risk-management-plan summary (PDF/232.35 KB)
First published: 19/12/2019
Last updated: 04/10/2022
Authorisation details
Product details | |
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Name |
Xeljanz
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Agency product number |
EMEA/H/C/004214
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Active substance |
Tofacitinib
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International non-proprietary name (INN) or common name |
tofacitinib
|
Therapeutic area (MeSH) |
Arthritis, Rheumatoid
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Anatomical therapeutic chemical (ATC) code |
L04AA29
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Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
26
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Date of issue of marketing authorisation valid throughout the European Union |
22/03/2017
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Contact address |
Boulevard de la Plaine 17 |
Product information
13/09/2022 Xeljanz - EMEA/H/C/004214 - PSUSA/00010588/202111
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
Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).
Psoriatic arthritis
Tofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1).
Ulcerative colitis
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).
Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).
Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Ankylosing spondylitis
Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
Assessment history
News
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20/05/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 202115/10/2021
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25/06/2021
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12/03/2021
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15/11/2019
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17/05/2019
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20/03/2019
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01/06/2018
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27/04/2018
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 201727/01/2017