Xeljanz

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tofacitinib

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the treatment of rheumatoid arthritis. The company that applied for authorisation is Pfizer Limited.

The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 25 July 2013.

This EPAR was last updated on 23/07/2018

Application details

Product details
Name
Xeljanz
Active substance
Tofacitinib
International non-proprietary name (INN) or common name
tofacitinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Application details
Marketing-authorisation applicant
Pfizer Limited
Date of opinion
25/07/2013

Assessment history

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