Xeljanz

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tofacitinib

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

Overview

An overview of Xeljanz and why it is authorised in the EU

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.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Xeljanz
Agency product number
EMEA/H/C/004214
Active substance
tofacitinib citrate
International non-proprietary name (INN) or common name
tofacitinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA29
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
Pfizer Limited
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
22/03/2017
Contact address
821 Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom

Product information

07/09/2018 Xeljanz - EMEA/H/C/004214 - IAIN/0014

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

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