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
-
List item
Xeljanz : EPAR - Public assessment report (PDF/4.66 MB)
Adopted
First published: 18/11/2013
Last updated: 18/11/2013
EMA/CHMP/425279/2013 -
List item
Questions and answers on refusal of the marketing authorisation for Xeljanz - Outcome of re-examination (PDF/75.06 KB)
Adopted
First published: 26/07/2013
Last updated: 26/07/2013
EMA/460814/2013 -
-
List item
Questions and answers on refusal of the marketing authorisation for Xeljanz (PDF/81.38 KB)
First published: 26/04/2013
Last updated: 26/04/2013
EMA/248755/2013