The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.
This EPAR was last updated on 22/07/2016 .
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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Krystexxa : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||2014-12-01||2016-07-22|
|Krystexxa-PSUSA-00010046-201501 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation||SV = svenska||2016-01-25||2016-07-22|
Initial marketing-authorisation documents
This medicine is now withdrawn from use in the European Union