• Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.

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)

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español (ES) (1.02 MB - PDF)

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čeština (CS) (1.07 MB - PDF)

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dansk (DA) (987.73 KB - PDF)

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Deutsch (DE) (988.53 KB - PDF)

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eesti keel (ET) (1.03 MB - PDF)

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ελληνικά (EL) (1.22 MB - PDF)

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français (FR) (990.13 KB - PDF)

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italiano (IT) (975.29 KB - PDF)

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latviešu valoda (LV) (1.15 MB - PDF)

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lietuvių kalba (LT) (1022.33 KB - PDF)

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magyar (HU) (1.06 MB - PDF)

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Malti (MT) (1.13 MB - PDF)

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Nederlands (NL) (987.81 KB - PDF)

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polski (PL) (1.07 MB - PDF)

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português (PT) (1.02 MB - PDF)

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română (RO) (1020.33 KB - PDF)

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slovenčina (SK) (1.07 MB - PDF)

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slovenščina (SL) (1.12 MB - PDF)

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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)

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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)

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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)

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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
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íslenska (IS) (932.41 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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italiano (IT) (991.66 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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latviešu valoda (LV) (987.38 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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lietuvių kalba (LT) (959.88 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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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
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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
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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
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slovenčina (SK) (1.01 MB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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slovenščina (SL) (969.12 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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Suomi (FI) (991.27 KB - PDF)

First published: 01/02/2013Last updated: 22/07/2016
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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
Revision
3

Assessment history

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

English (EN) (1005.03 KB - PDF)

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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)

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Krystexxa : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/697253/2012

English (EN) (5.41 MB - PDF)

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CHMP summary of positive opinion for Krystexxa

AdoptedReference Number: EMA/CHMP/672303/2012

English (EN) (970.17 KB - PDF)

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More information on Krystexxa

Public statement on Krystexxa: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/498114/2016

English (EN) (57.86 KB - PDF)

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