Krystexxa

pegloticase

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The marketing authorisation for Krystexxa has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Krystexxa : EPAR - Summary for the public BG = bălgarski 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public ES = español 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public CS = čeština 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public DA = dansk 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public DE = Deutsch 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public ET = eesti keel 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public EL = elliniká 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public EN = English 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public FR = français 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public IT = italiano 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public LV = latviešu valoda 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public LT = lietuvių kalba 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public HU = magyar 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public MT = Malti 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public NL = Nederlands 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public PL = polski 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public PT = português 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public RO = română 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public SK = slovenčina 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public SL = slovenščina 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public FI = suomi 2013-02-01 2016-07-22
Krystexxa : EPAR - Summary for the public SV = svenska 2013-02-01 2016-07-22

This EPAR was last updated on 22/07/2016 .

Authorisation details

Product details

Product details for Krystexxa
NameKrystexxa
Agency product numberEMEA/H/C/002208
Active substance

pegloticase

International non-proprietary name (INN) or common name

pegloticase

Therapeutic area Gout
Anatomical therapeutic chemical (ATC) code M04AX02

Publication details

Publication details for Krystexxa
Marketing-authorisation holder

Crealta Pharmaceuticals Ireland Limited

Revision3
Date of issue of marketing authorisation valid throughout the European Union08/01/2013

Contact address:

Crealta Pharmaceuticals Ireland Limited
Commercial House
Millbank Business Park
Lower Lucan Road
Lucan, Co.
Dublin 
Ireland

Product information

Product information

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

Name Language First published Last updated
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - Product Information SV = svenska 2013-02-01 2016-07-22

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.


Name Language First published Last updated
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22
Krystexxa : EPAR - All Authorised presentations SV = svenska 2013-02-01 2016-07-22

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Krystexxa : EPAR - Public assessment report SV = svenska 2013-02-01 2016-07-22
CHMP summary of positive opinion for Krystexxa SV = svenska 2012-10-19 2016-07-22

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Krystexxa