Duzallo

Withdrawn

This medicine's authorisation has been withdrawn

allopurinol / lesinurad

Overview

The marketing authorisation for Duzallo has been withdrawn at the request of the marketing-authorisation holder.

Duzallo : EPAR - Medicine overview

Reference Number: EMA/455545/2018

Duzallo : EPAR - Risk-management-plan summary

Product information

Duzallo : EPAR - 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).

Duzallo : EPAR - All Authorised presentations

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 preparations

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/004412
• Marketing authorisation holder:
  Grunenthal GmbH

  Zieglerstrasse 6 ; D-52078 Aachen ; Germany

• Opinion adopted:
  28/06/2019
• Marketing authorisation issued:
  23/08/2018
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Duzallo : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Duzallo : EPAR - Public assessment report

Reference Number: EMA/474026/2018

CHMP summary of positive opinion for Duzallo

AdoptedReference Number: EMA/CHMP/374196/2018