Zurampic

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lesinurad

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zurampic has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 31/07/2020

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 monitoringAdditional 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
4
Date of issue of marketing authorisation valid throughout the European Union
18/02/2016
Contact address
Zieglerstr. 6
D-52078Aachen
Germany

Product information

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

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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