Krystexxa
pegloticase
Table of contents
Overview
The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.
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 |
Commercial House
Millbank Business Park Lower Lucan Road Lucan, Co. Dublin Ireland |
Product information
30/06/2016 Krystexxa - EMEA/H/C/002208 - PSUSA/00010046/201501
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antigout preparations
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.