Xeljanz
tofacitinib
Table of contents
Overview
Xeljanz is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints, and 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 medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
In patients with rheumatoid arthritis, Xeljanz can also be taken alone by patients who cannot take or are intolerant to methotrexate.
Xeljanz is also used to treat adults with moderate to severe ulcerative colitis, a disease causing inflammation and ulcers 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.
Xeljanz contains the active substance tofacitinib.
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List item
Xeljanz : EPAR - Medicine overview (PDF/105.91 KB)
First published: 31/03/2017
Last updated: 06/03/2020
EMA/687021/2019 -
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List item
Xeljanz : EPAR - Risk-management-plan summary (PDF/1.84 MB)
First published: 19/12/2019
Last updated: 14/12/2020
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 citrate
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International non-proprietary name (INN) or common name |
tofacitinib
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Therapeutic area (MeSH) |
Arthritis, Rheumatoid
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Anatomical therapeutic chemical (ATC) code |
L04AA29
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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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
21/03/2017
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Contact address |
Product information
14/01/2021 Xeljanz - EMEA/H/C/004214 - IB/0031
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Xeljanz 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.
Xeljanz 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).
Assessment history
News
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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