Duzallo
allopurinol / lesinurad
Table of contents
Overview
The marketing authorisation for Duzallo has been withdrawn at the request of the marketing-authorisation holder.
-
List item
Duzallo : EPAR - Medicine overview (PDF/668.09 KB)
First published: 24/08/2018
Last updated: 06/08/2020
EMA/455545/2018 -
-
List item
Duzallo : EPAR - Risk-management-plan summary (PDF/742.47 KB)
First published: 24/08/2018
Last updated: 06/08/2020
Authorisation details
| Product details | |
|---|---|
| Name |
Duzallo
|
| Agency product number |
EMEA/H/C/004412
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Gout
|
| Anatomical therapeutic chemical (ATC) code |
M04AA51
|
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 |
Grunenthal GmbH
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/08/2018
|
| Contact address |
Zieglerstrasse 6
D-52078 Aachen Germany |
Product information
31/07/2019 Duzallo - EMEA/H/C/004412 - IB/0002/G
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
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.