Table of contents
The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.
Krystexxa : EPAR - Summary for the public (PDF/521.09 KB)Adopted
First published: 01/02/2013
Last updated: 22/07/2016
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|International non-proprietary name (INN) or common name||
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|Anatomical therapeutic chemical (ATC) code||
Crealta Pharmaceuticals Ireland Limited
|Date of issue of marketing authorisation valid throughout the European Union||
Millbank Business Park
Lower Lucan Road
30/06/2016 Krystexxa - EMEA/H/C/002208 - PSUSA/00010046/201501
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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.