Overview

The marketing authorisation for Zurampic has been withdrawn at the request of the marketing-authorisation holder.

Zurampic : EPAR - Summary for the public

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dansk (DA) (665.65 KB - PDF)

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Deutsch (DE) (675 KB - PDF)

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eesti keel (ET) (664.65 KB - PDF)

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ελληνικά (EL) (797.09 KB - PDF)

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français (FR) (669.95 KB - PDF)

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hrvatski (HR) (692.16 KB - PDF)

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italiano (IT) (665.27 KB - PDF)

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latviešu valoda (LV) (745.3 KB - PDF)

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lietuvių kalba (LT) (696.61 KB - PDF)

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magyar (HU) (740.39 KB - PDF)

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Malti (MT) (748.22 KB - PDF)

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Nederlands (NL) (666.54 KB - PDF)

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polski (PL) (745.3 KB - PDF)

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português (PT) (667.58 KB - PDF)

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română (RO) (695.55 KB - PDF)

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slovenčina (SK) (745.61 KB - PDF)

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slovenščina (SL) (736.92 KB - PDF)

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Suomi (FI) (665.54 KB - PDF)

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svenska (SV) (666.38 KB - PDF)

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Zurampic : EPAR - Risk-management-plan summary

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Product information

Zurampic : EPAR - Product Information

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български (BG) (1.76 MB - PDF)

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español (ES) (1.11 MB - PDF)

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čeština (CS) (1.44 MB - PDF)

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dansk (DA) (1007.97 KB - PDF)

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Deutsch (DE) (989.18 KB - PDF)

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eesti keel (ET) (952.47 KB - PDF)

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ελληνικά (EL) (1.72 MB - PDF)

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français (FR) (1019.21 KB - PDF)

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hrvatski (HR) (965.33 KB - PDF)

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íslenska (IS) (998.87 KB - PDF)

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italiano (IT) (998.56 KB - PDF)

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latviešu valoda (LV) (1.65 MB - PDF)

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lietuvių kalba (LT) (995.1 KB - PDF)

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magyar (HU) (1.44 MB - PDF)

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Malti (MT) (1.48 MB - PDF)

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Nederlands (NL) (969.94 KB - PDF)

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norsk (NO) (1.06 MB - PDF)

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polski (PL) (1.44 MB - PDF)

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português (PT) (994.6 KB - PDF)

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română (RO) (1012.13 KB - PDF)

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slovenčina (SK) (1.53 MB - PDF)

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slovenščina (SL) (1.51 MB - PDF)

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Suomi (FI) (973.31 KB - PDF)

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svenska (SV) (962.77 KB - PDF)

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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.
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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)

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čeština (CS) (617.96 KB - PDF)

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dansk (DA) (602.13 KB - PDF)

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Deutsch (DE) (602.13 KB - PDF)

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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)

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français (FR) (600.35 KB - PDF)

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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)

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italiano (IT) (600.85 KB - PDF)

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latviešu valoda (LV) (618.91 KB - PDF)

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lietuvių kalba (LT) (601.91 KB - PDF)

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magyar (HU) (617.04 KB - PDF)

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Malti (MT) (618.15 KB - PDF)

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Nederlands (NL) (600.81 KB - PDF)

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norsk (NO) (602 KB - PDF)

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polski (PL) (617.96 KB - PDF)

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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)

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

Reference Number: EMA/CHMP/358247/2020 Corr.

English (EN) (125.47 KB - PDF)

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