Duzallo
Withdrawn
This medicine's authorisation has been withdrawn
allopurinol / lesinurad
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 31 July 2020, the European Commission withdrew the marketing authorisation for Duzallo (allopurinol / lesinurad) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Grunenthal GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Duzallo was granted marketing authorisation in the EU on 23 August 2018 for gout. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2018.
The European Public Assessment Report (EPAR) for Duzallo is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IB/0002/G
31/07/2019
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
- Duzallo
- Active substance
- allopurinol
- lesinurad
- International non-proprietary name (INN) or common name
- allopurinol
- lesinurad
- Therapeutic area (MeSH)
- Gout
- Anatomical therapeutic chemical (ATC) code
- M04AA51
Pharmacotherapeutic group
Antigout preparationsTherapeutic indication
Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.
News on Duzallo
This page was last updated on