Krystexxa

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pegloticase

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.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
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

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Product information documents contain:

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.

Assessment history

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