Krystexxa

RSS

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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.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
07/01/2013
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

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

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.

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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