• Application under evaluation
  • CHMP opinion
  • European Commission decision

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The marketing authorisation for Duzallo has been withdrawn at the request of the marketing-authorisation holder.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

English (EN) (668.09 KB - PDF)

First published: Last updated:
View

български (BG) (780.71 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

español (ES) (684.16 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

čeština (CS) (751.99 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

dansk (DA) (680.84 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Deutsch (DE) (684.99 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

eesti keel (ET) (679.15 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

ελληνικά (EL) (790.77 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

français (FR) (685.18 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

hrvatski (HR) (698.5 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

italiano (IT) (683.73 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

latviešu valoda (LV) (737.62 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

lietuvių kalba (LT) (704.71 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

magyar (HU) (744.31 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Malti (MT) (752.99 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Nederlands (NL) (684.07 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

polski (PL) (751.21 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

português (PT) (683.78 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

română (RO) (703.65 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

slovenčina (SK) (751.33 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

slovenščina (SL) (744.53 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Suomi (FI) (683.59 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

svenska (SV) (680.84 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Duzallo : EPAR - Risk-management-plan summary

English (EN) (742.47 KB - PDF)

First published: Last updated:
View

Product information

Duzallo : EPAR - Product Information

English (EN) (1.22 MB - PDF)

First published: Last updated:
View

български (BG) (2.19 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

español (ES) (1.06 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

čeština (CS) (1.8 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

dansk (DA) (1.06 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Deutsch (DE) (1.08 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

eesti keel (ET) (1.05 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

ελληνικά (EL) (2.19 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

français (FR) (1.08 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

hrvatski (HR) (1.05 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

íslenska (IS) (1.06 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

italiano (IT) (1.06 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

latviešu valoda (LV) (1.83 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

lietuvių kalba (LT) (310.39 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

magyar (HU) (1.8 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Malti (MT) (1.89 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Nederlands (NL) (2.57 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

norsk (NO) (1.05 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

polski (PL) (1.84 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

português (PT) (1.06 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

română (RO) (1.09 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

slovenčina (SK) (1.8 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

slovenščina (SL) (1.76 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Suomi (FI) (307.79 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

svenska (SV) (1.05 MB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View
Latest procedure affecting product information: IB/0002/G
31/07/2019
icon globe

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

English (EN) (643.98 KB - PDF)

First published: Last updated:
View

български (BG) (668.21 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

español (ES) (644.06 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

čeština (CS) (660.86 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

dansk (DA) (644.95 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Deutsch (DE) (644.9 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

eesti keel (ET) (644.55 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

ελληνικά (EL) (667.74 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

français (FR) (643.47 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

hrvatski (HR) (643.66 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

íslenska (IS) (643.5 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

italiano (IT) (643.5 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

latviešu valoda (LV) (661.54 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

lietuvių kalba (LT) (644.78 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

magyar (HU) (660.24 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Malti (MT) (660.12 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Nederlands (NL) (665.04 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

norsk (NO) (645.67 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

polski (PL) (660.39 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

português (PT) (644.36 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

română (RO) (644.37 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

slovenčina (SK) (660.88 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

slovenščina (SL) (659.37 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

Suomi (FI) (644.54 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

svenska (SV) (644.23 KB - PDF)

First published: 24/08/2018Last updated: 06/08/2020
View

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

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

English (EN) (728.91 KB - PDF)

First published: Last updated:
View

Duzallo : EPAR - Public assessment report

Reference Number: EMA/474026/2018

English (EN) (5.17 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Duzallo

AdoptedReference Number: EMA/CHMP/374196/2018

English (EN) (645.28 KB - PDF)

First published: Last updated:
View

More information on Duzallo

Public statement on Duzallo: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/CHMP/358236/2020

English (EN) (118.21 KB - PDF)

First published:
View

Topics

This page was last updated on

Share this page