Krystexxa
pegloticase
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.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
Authorisation details
| Product details | |
|---|---|
| Name |
Krystexxa
|
| Agency product number |
EMEA/H/C/002208
|
| Active substance |
pegloticase
|
| International non-proprietary name (INN) or common name |
pegloticase
|
| Therapeutic area (MeSH) |
Gout
|
| Anatomical therapeutic chemical (ATC) code |
M04AX02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Crealta Pharmaceuticals Ireland Limited
|
| Revision |
3
|
| Date of issue of marketing authorisation valid throughout the European Union |
08/01/2013
|
| Contact address | |
Product information
30/06/2016 Krystexxa - EMEA/H/C/002208 - PSUSA/00010046/201501
Contents
- 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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Pharmacotherapeutic group
Pharmacotherapeutic group
Antigout preparations
Therapeutic indication
Therapeutic 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.