Krystexxa : EPAR - Summary for the public (PDF/521.09 KB)Adopted
First published: 01/02/2013
Last updated: 22/07/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Crealta Pharmaceuticals Ireland Limited
|Date of issue of marketing authorisation valid throughout the European Union||
30/06/2016 Krystexxa - EMEA/H/C/002208 - PSUSA/00010046/201501
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.