Zurampic

RSS

Withdrawn

This medicine's authorisation has been withdrawn

lesinurad
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

Translate to Romanian | Important information about machine translation

  • 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issued a notification that the marketing authorisation for Zurampic (lesinurad) in the European Union (EU) had been withdrawn.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The European Public Assessment Report (EPAR) for Zurampic is updated to indicate that the marketing authorisation is no longer valid.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)

Prima publicare: Cea mai recent:
Vizualizare

български (BG) (766.38 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

español (ES) (667.19 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

čeština (CS) (745.71 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

dansk (DA) (665.65 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

Deutsch (DE) (675 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

eesti (ET) (664.65 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

ελληνικά (EL) (797.09 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

français (FR) (669.95 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

hrvatski (HR) (692.16 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

italiano (IT) (665.27 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

latviešu (LV) (745.3 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

lietuvių (LT) (696.61 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

magyar (HU) (740.39 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

Malti (MT) (748.22 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

Nederlands (NL) (666.54 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

polski (PL) (745.3 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

português (PT) (667.58 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

română (RO) (695.55 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

slovenčina (SK) (745.61 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

slovenščina (SL) (736.92 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

suomi (FI) (665.54 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

svenska (SV) (666.38 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 09/03/2016
Vizualizare

Zurampic : EPAR - Risk-management-plan summary

English (EN) (646.13 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

Product information

Zurampic : EPAR - Product Information

English (EN) (954.17 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

български (BG) (1.76 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

español (ES) (1.11 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

čeština (CS) (1.44 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

dansk (DA) (1007.97 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Deutsch (DE) (989.18 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

eesti (ET) (952.47 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

ελληνικά (EL) (1.72 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

français (FR) (1019.21 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

hrvatski (HR) (965.33 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

italiano (IT) (998.56 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

latviešu (LV) (1.65 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

lietuvių (LT) (995.1 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

magyar (HU) (1.44 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Malti (MT) (1.48 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Nederlands (NL) (969.94 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

polski (PL) (1.44 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

português (PT) (994.6 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

română (RO) (1012.13 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

slovenčina (SK) (1.53 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

slovenščina (SL) (1.51 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

suomi (FI) (973.31 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

svenska (SV) (962.77 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Íslenska (IS) (998.87 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

norsk (NO) (1.06 MB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare
Latest procedure affecting product information:IA/0008
15/06/2017
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).

Zurampic : EPAR - All Authorised presentations

English (EN) (602.77 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

български (BG) (625.33 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

español (ES) (600.63 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

čeština (CS) (617.96 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

dansk (DA) (602.13 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Deutsch (DE) (602.13 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

eesti (ET) (594.5 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

ελληνικά (EL) (624.82 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

français (FR) (600.35 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

hrvatski (HR) (601.1 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

italiano (IT) (600.85 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

latviešu (LV) (618.91 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

lietuvių (LT) (601.91 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

magyar (HU) (617.04 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Malti (MT) (618.15 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Nederlands (NL) (600.81 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

polski (PL) (617.96 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

português (PT) (601.06 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

română (RO) (600.99 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

slovenčina (SK) (618.33 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

slovenščina (SL) (616.75 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

suomi (FI) (600.56 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

svenska (SV) (600.56 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

Íslenska (IS) (601.08 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

norsk (NO) (602 KB - PDF)

Prima publicare: 09/03/2016 Cea mai recent: 06/07/2017
Vizualizare

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)

Prima publicare: Cea mai recent:
Vizualizare

Zurampic : EPAR - Public assessment report

Adopted Reference Number: EMA/6459/2016

English (EN) (5.54 MB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

CHMP summary of opinion for Zurampic

Adopted Reference Number: EMA/CHMP/824058/2015

English (EN) (677.31 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare
This page was last updated on

Share this page