Krystexxa

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

30/06/2016 Krystexxa - EMEA/H/C/002208 - PSUSA/00010046/201501

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Krystexxa : EPAR - Product Information (PDF/1.41 MB)

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

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Krystexxa : EPAR - All Authorised presentations (PDF/931.95 KB)

First published: 01/02/2013
Last updated: 22/07/2016
- Bulgarian
  (PDF/1.03 MB)
- Czech
  (PDF/985.9 KB)
- Danish
  (PDF/991.86 KB)
- Dutch
  (PDF/991.98 KB)
- Estonian
  (PDF/932.05 KB)
- Finnish
  (PDF/991.27 KB)
- French
  (PDF/932.36 KB)
- German
  (PDF/932.25 KB)
- Greek
  (PDF/527.69 KB)
- Hungarian
  (PDF/969.58 KB)
- Icelandic
  (PDF/932.41 KB)
- Italian
  (PDF/991.66 KB)
- Latvian
  (PDF/987.38 KB)
- Lithuanian
  (PDF/959.88 KB)
- Maltese
  (PDF/1.02 MB)
- Norwegian
  (PDF/932.37 KB)
- Polish
  (PDF/1.02 MB)
- Portuguese
  (PDF/932.67 KB)
- Romanian
  (PDF/959.71 KB)
- Slovak
  (PDF/1.01 MB)
- Slovenian
  (PDF/969.12 KB)
- Spanish
  (PDF/932.55 KB)
- Swedish
  (PDF/992.26 KB)

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.

Table of contents

Overview

Krystexxa : EPAR - Summary for the public (PDF/521.09 KB)

Authorisation details

Product information

Krystexxa : EPAR - Product Information (PDF/1.41 MB)

Contents

Krystexxa : EPAR - All Authorised presentations (PDF/931.95 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Krystexxa : EPAR - Procedural steps taken and scientific information after authorisation (PDF/1005.03 KB)

Krystexxa-PSUSA-00010046-201501 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/1003.14 KB)

Initial marketing-authorisation documents

Krystexxa : EPAR - Public assessment report (PDF/5.41 MB)

CHMP summary of positive opinion for Krystexxa (PDF/970.17 KB)

More information on Krystexxa

Public statement on Krystexxa: Withdrawal of the marketing authorisation in the European Union (PDF/57.86 KB)

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