Zurampic

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Withdrawn

This medicine's authorisation has been withdrawn

lesinurad
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 31 July 2020, the European Commission issued a notification that the marketing authorisation for Zurampic (lesinurad) in the European Union (EU) had been withdrawn. The withdrawal was at the request of the marketing authorisation holder, Grunenthal GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Zurampic was granted marketing authorisation in the EU on 18 February 2016 for treatment of hyperuricaemia. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Zurampic is updated to indicate that the marketing authorisation is no longer valid.

Zurampic : EPAR - Summary for the public

English (EN) (670.89 KB - PDF)

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български (BG) (766.38 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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español (ES) (667.19 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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čeština (CS) (745.71 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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dansk (DA) (665.65 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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Deutsch (DE) (675 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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eesti keel (ET) (664.65 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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ελληνικά (EL) (797.09 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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français (FR) (669.95 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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hrvatski (HR) (692.16 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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italiano (IT) (665.27 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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latviešu valoda (LV) (745.3 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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lietuvių kalba (LT) (696.61 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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magyar (HU) (740.39 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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Malti (MT) (748.22 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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Nederlands (NL) (666.54 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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polski (PL) (745.3 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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português (PT) (667.58 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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română (RO) (695.55 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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slovenčina (SK) (745.61 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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slovenščina (SL) (736.92 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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Suomi (FI) (665.54 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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svenska (SV) (666.38 KB - PDF)

First published: 09/03/2016Last updated: 09/03/2016
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Zurampic : EPAR - Risk-management-plan summary

English (EN) (646.13 KB - PDF)

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Product information

Zurampic : EPAR - Product Information

English (EN) (954.17 KB - PDF)

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български (BG) (1.76 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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español (ES) (1.11 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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čeština (CS) (1.44 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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dansk (DA) (1007.97 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Deutsch (DE) (989.18 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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eesti keel (ET) (952.47 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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ελληνικά (EL) (1.72 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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français (FR) (1019.21 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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hrvatski (HR) (965.33 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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íslenska (IS) (998.87 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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italiano (IT) (998.56 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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latviešu valoda (LV) (1.65 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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lietuvių kalba (LT) (995.1 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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magyar (HU) (1.44 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Malti (MT) (1.48 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Nederlands (NL) (969.94 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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norsk (NO) (1.06 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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polski (PL) (1.44 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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português (PT) (994.6 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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română (RO) (1012.13 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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slovenčina (SK) (1.53 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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slovenščina (SL) (1.51 MB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Suomi (FI) (973.31 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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svenska (SV) (962.77 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Latest procedure affecting product information: IA/0008
15/06/2017
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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).

Zurampic : EPAR - All Authorised presentations

English (EN) (602.77 KB - PDF)

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български (BG) (625.33 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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español (ES) (600.63 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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čeština (CS) (617.96 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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dansk (DA) (602.13 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Deutsch (DE) (602.13 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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eesti keel (ET) (594.5 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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ελληνικά (EL) (624.82 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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français (FR) (600.35 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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hrvatski (HR) (601.1 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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íslenska (IS) (601.08 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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italiano (IT) (600.85 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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latviešu valoda (LV) (618.91 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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lietuvių kalba (LT) (601.91 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
View

magyar (HU) (617.04 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Malti (MT) (618.15 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Nederlands (NL) (600.81 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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norsk (NO) (602 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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polski (PL) (617.96 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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português (PT) (601.06 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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română (RO) (600.99 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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slovenčina (SK) (618.33 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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slovenščina (SL) (616.75 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Suomi (FI) (600.56 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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svenska (SV) (600.56 KB - PDF)

First published: 09/03/2016Last updated: 06/07/2017
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Product details

Name of medicine
Zurampic
Active substance
lesinurad
International non-proprietary name (INN) or common name
lesinurad
Therapeutic area (MeSH)
Hyperuricemia
Anatomical therapeutic chemical (ATC) code
M04AB05

Pharmacotherapeutic group

Antigout preparations

Therapeutic indication

Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.

Authorisation details

EMA product number
EMEA/H/C/003932
Marketing authorisation holder
Grünenthal GmbH

Zieglerstr. 6
D-52078Aachen
Germany

Marketing authorisation issued
18/02/2016
Revision
4

Assessment history

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

English (EN) (765.72 KB - PDF)

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Zurampic : EPAR - Public assessment report

AdoptedReference Number: EMA/6459/2016

English (EN) (5.54 MB - PDF)

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CHMP summary of opinion for Zurampic

AdoptedReference Number: EMA/CHMP/824058/2015

English (EN) (677.31 KB - PDF)

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