Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


REFUSED  

Product information

Invented name: Xeljanz
Auth. number : EU/1/13/874
INN : tofacitinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA29 - Tofacitinib
(See WHO ATC Index)
Indication: Treatment of rheumatoid arthritis in adult patients
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/11/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2542 (2013)7873 of 08/11/2013