Zurampic

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lesinurad

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Zurampic. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zurampic.

For practical information about using Zurampic, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/07/2017

Authorisation details

Product details
Name
Zurampic
Agency product number
EMEA/H/C/003932
Active substance
lesinurad
International non-proprietary name (INN) or common name
lesinurad
Therapeutic area (MeSH)
Hyperuricemia
Anatomical therapeutic chemical (ATC) code
M04AB05
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Grünenthal GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
17/02/2016
Contact address
Zieglerstr. 6
D-52078Aachen
Germany

Product information

15/06/2017 Zurampic - EMEA/H/C/003932 - IA/0008

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.

Pharmacotherapeutic group

ANTIGOUT PREPARATIONS

Therapeutic indication

Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.

Assessment history

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