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On 28 June 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Duzallo, intended for the treatment of hyperuricaemia in gout patients. The applicant for this medicinal product is Gruenenthal GmbH.

Duzallo is a fixed dose combination of two active substances, lesinurad and allopurinol. It will be available as film-coated tablets (300 mg/200 mg and 200 mg/200 mg). Lesinurad is a selective uric acid reabsorption inhibitor that inhibits uric acid transporter 1, and allopurinol reduces uric acid production by inhibition of xanthine oxidase (ATC code: M04AA51).

The benefit of Duzallo is its ability to lower the level of uric acid in plasma and urine through increased uric acid excretion and decreased uric acid production. The most common side effects are influenza, gastro-oesophageal reflux disease, headache and increased blood creatinine.

The full indication is:

'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.'

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Duzallo (English only) 2018-06-29  

Key facts

Product details for Duzallo
INN or common name

allopurinol / lesinurad

Therapeutic area Gout
Active substance

allopurinol / lesinurad

Date opinion adopted28/06/2018
Company name

Gruenenthal GmbH

Application typeInitial authorisation