Zurampic
lesinurad
Table of contents
Overview
The marketing authorisation for Zurampic has been withdrawn at the request of the marketing-authorisation holder.
-
List item
Zurampic : EPAR - Summary for the public (PDF/670.89 KB)
First published: 09/03/2016
Last updated: 09/03/2016 -
-
List item
Zurampic : EPAR - Risk-management-plan summary (PDF/646.13 KB)
First published: 09/03/2016
Last updated: 09/03/2016
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 |
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
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).
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.