Krystexxa

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Withdrawn

This medicine's authorisation has been withdrawn

pegloticase
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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Public Assessment Report (EPAR) for Krystexxa is updated accordingly to indicate that the marketing authorisation is no longer valid.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

AdoptedReference Number: EMA/CHMP/17512/2013

English (EN) (521.09 KB - PDF)

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български (BG) (1.13 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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español (ES) (1.02 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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čeština (CS) (1.07 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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dansk (DA) (987.73 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Deutsch (DE) (988.53 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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eesti keel (ET) (1.03 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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ελληνικά (EL) (1.22 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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français (FR) (990.13 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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italiano (IT) (975.29 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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latviešu valoda (LV) (1.15 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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lietuvių kalba (LT) (1022.33 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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magyar (HU) (1.06 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Malti (MT) (1.13 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Nederlands (NL) (987.81 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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polski (PL) (1.07 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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português (PT) (1.02 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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română (RO) (1020.33 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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slovenčina (SK) (1.07 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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slovenščina (SL) (1.12 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Suomi (FI) (985.93 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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svenska (SV) (983.73 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Product information

Krystexxa : EPAR - Product Information

English (EN) (1.41 MB - PDF)

First published: Last updated:
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български (BG) (2.54 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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español (ES) (1.41 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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čeština (CS) (2.15 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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dansk (DA) (1.4 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Deutsch (DE) (1.44 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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eesti keel (ET) (1.4 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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ελληνικά (EL) (2.63 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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français (FR) (1.48 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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hrvatski (HR) (1.48 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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íslenska (IS) (1.43 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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italiano (IT) (1.5 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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latviešu valoda (LV) (2.21 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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lietuvių kalba (LT) (1.54 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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magyar (HU) (2.18 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Malti (MT) (2.27 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Nederlands (NL) (1.42 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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norsk (NO) (1.41 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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polski (PL) (2.18 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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português (PT) (1.45 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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română (RO) (1.48 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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slovenčina (SK) (2.16 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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slovenščina (SL) (2.13 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Suomi (FI) (1.41 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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svenska (SV) (1.41 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Latest procedure affecting product information: PSUSA/00010046/201501
30/06/2016
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

Krystexxa : EPAR - All Authorised presentations

English (EN) (931.95 KB - PDF)

First published: Last updated:
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български (BG) (1.03 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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español (ES) (932.55 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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čeština (CS) (985.9 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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dansk (DA) (991.86 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Deutsch (DE) (932.25 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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eesti keel (ET) (932.05 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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ελληνικά (EL) (527.69 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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français (FR) (932.36 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

íslenska (IS) (932.41 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

italiano (IT) (991.66 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

latviešu valoda (LV) (987.38 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

lietuvių kalba (LT) (959.88 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

magyar (HU) (969.58 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Malti (MT) (1.02 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

Nederlands (NL) (991.98 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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norsk (NO) (932.37 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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polski (PL) (1.02 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

português (PT) (932.67 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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română (RO) (959.71 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

slovenčina (SK) (1.01 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

slovenščina (SL) (969.12 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

Suomi (FI) (991.27 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
View

svenska (SV) (992.26 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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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

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

English (EN) (1005.03 KB - PDF)

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

Reference Number: EMA/697925/2015

English (EN) (1003.14 KB - PDF)

First published: Last updated:
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Krystexxa : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/697253/2012

English (EN) (5.41 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Krystexxa

AdoptedReference Number: EMA/CHMP/672303/2012

English (EN) (970.17 KB - PDF)

First published: Last updated:
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