Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Krystexxa   
Auth. number : EU/1/12/810
Active substance : pegloticase
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M04 - Antigout preparations
Pharmacological subgroup: M04A - Antigout preparations
Chemical subgroup: M04AX - Other antigout preparations
Chemical substance: M04AX02 - Pegloticase
(See WHO ATC Index)
Indication: KRYSTEXXA is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient.
Marketing Authorisation Holder: Crealta Pharmaceuticals Ireland Limited
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland
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
10/01/2013 Centralised - Authorisation EMEA/H/C/2208 (2013)47 of 08/01/2013
29/03/2013 Corrigendum (2013)1972 of 27/03/2013
02/04/2013 Corrigendum (2013)47 of 08/01/2013
13/10/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2208/T/5 (2014)7475 of 08/10/2014
23/11/2015 PSUSA - Modification EMEA/H/C/PSUSA/10046/201501 (2015)8275 of 19/11/2015