- Current languageen
Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/12/810|
|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:||Savient Pharma Ireland Limited
Mespil House, Sussex Road, Dublin 4, Ireland
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|