Krystexxa

Withdrawn

This medicine's authorisation has been withdrawn

pegloticase

Overview

On 30 June 2016 the European Commission withdrew the marketing authorisation for Krystexxa (pegloticase) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Crealta Pharmaceuticals Ireland Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Krystexxa was granted marketing authorisation in the EU on 8 January 2013 for treatment of chronic gout. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Krystexxa is updated accordingly to indicate that the marketing authorisation is no longer valid.

Krystexxa : EPAR - Summary for the public

Adopted Reference Number: EMA/CHMP/17512/2013

Product information

Krystexxa : EPAR - Product Information

Krystexxa : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Krystexxa
• Active substance:
  pegloticase
• International non-proprietary name (INN) or common name:
  pegloticase
• Therapeutic area (MeSH):
  Gout
• Anatomical therapeutic chemical (ATC) code:
  M04AX02

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002208
• Marketing authorisation holder:
  Crealta Pharmaceuticals Ireland Limited

  Commercial House; Millbank Business Park; Lower Lucan Road; Lucan, Co.; Dublin ; Ireland

• Marketing authorisation issued:
  08/01/2013
• Withdrawal of marketing authorisation:
  30/06/2016
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Krystexxa : EPAR - Procedural steps taken and scientific information after authorisation

Krystexxa-PSUSA-00010046-201501 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/697925/2015

Initial marketing authorisation documents

Krystexxa : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/697253/2012

CHMP summary of positive opinion for Krystexxa

Adopted Reference Number: EMA/CHMP/672303/2012