Zurampic
Withdrawn
This medicine's authorisation has been withdrawn
lesinurad
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 31 July 2020, the European Commission issued a notification that the marketing authorisation for Zurampic (lesinurad) in the European Union (EU) had been withdrawn. The withdrawal was at the request of the marketing authorisation holder, Grunenthal GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Zurampic was granted marketing authorisation in the EU on 18 February 2016 for treatment of hyperuricaemia. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Zurampic is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IA/0008
15/06/2017
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).
Product details
- Name of medicine
- Zurampic
- Active substance
- lesinurad
- International non-proprietary name (INN) or common name
- lesinurad
- Therapeutic area (MeSH)
- Hyperuricemia
- Anatomical therapeutic chemical (ATC) code
- M04AB05
Pharmacotherapeutic group
Antigout preparationsTherapeutic 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.
News on Zurampic
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