Zalviso

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Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 5 August 2022, the European Commission withdrew the marketing authorisation for Zalviso (sufentanil) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, FGK Representative Service GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Zalviso was granted marketing authorisation in the EU on 18 September 2015 for the management of acute moderate to severe post-operative pain. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2020. 

The European Public Assessment Report (EPAR) for Zalviso is updated to indicate that the marketing authorisation is no longer valid.

Zalviso : EPAR - Summary for the public

English (EN) (663.58 KB - PDF)

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български (BG) (760.64 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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español (ES) (667.71 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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čeština (CS) (739.15 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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dansk (DA) (665.9 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Deutsch (DE) (670.41 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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eesti keel (ET) (665.35 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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ελληνικά (EL) (762.93 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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français (FR) (669.36 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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hrvatski (HR) (686.42 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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italiano (IT) (666.44 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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latviešu valoda (LV) (738.28 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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lietuvių kalba (LT) (688.61 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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magyar (HU) (733.2 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Malti (MT) (741.01 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Nederlands (NL) (667.09 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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polski (PL) (738.41 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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português (PT) (668.03 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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română (RO) (688.79 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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slovenčina (SK) (737.52 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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slovenščina (SL) (730.65 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Suomi (FI) (665.44 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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svenska (SV) (667.37 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Zalviso : EPAR - Risk-management-plan summary

English (EN) (656.57 KB - PDF)

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Product information

Zalviso : EPAR - Product Information

English (EN) (1.16 MB - PDF)

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български (BG) (2.02 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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español (ES) (1.14 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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čeština (CS) (1.73 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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dansk (DA) (1.14 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Deutsch (DE) (1.08 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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eesti keel (ET) (1.15 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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ελληνικά (EL) (2.07 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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français (FR) (1.17 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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hrvatski (HR) (1.23 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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íslenska (IS) (1.11 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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italiano (IT) (1.08 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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latviešu valoda (LV) (3.17 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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lietuvių kalba (LT) (1.21 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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magyar (HU) (1.8 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Malti (MT) (1.81 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Nederlands (NL) (1.13 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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norsk (NO) (1.14 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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polski (PL) (1.77 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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português (PT) (1.14 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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română (RO) (1.24 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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slovenčina (SK) (1.72 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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slovenščina (SL) (1.74 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Suomi (FI) (1.05 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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svenska (SV) (1.14 MB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Latest procedure affecting product information: T/0017
05/08/2022
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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).

Zalviso : EPAR - All Authorised presentations

English (EN) (590.39 KB - PDF)

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български (BG) (630.83 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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español (ES) (589.36 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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čeština (CS) (612.66 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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dansk (DA) (588.95 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Deutsch (DE) (588.89 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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eesti keel (ET) (588.92 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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ελληνικά (EL) (629.13 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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français (FR) (589.08 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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hrvatski (HR) (600.21 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

íslenska (IS) (588.96 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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italiano (IT) (589.31 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

latviešu valoda (LV) (622.41 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

lietuvių kalba (LT) (605.38 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

magyar (HU) (618.12 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Malti (MT) (620.25 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Nederlands (NL) (589.22 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

norsk (NO) (589.15 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

polski (PL) (620.57 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

português (PT) (589.37 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

română (RO) (606.42 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

slovenčina (SK) (619.68 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

slovenščina (SL) (618.15 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
View

Suomi (FI) (589.19 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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svenska (SV) (589.02 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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Product details

Name of medicine
Zalviso
Active substance
sufentanil
International non-proprietary name (INN) or common name
sufentanil
Therapeutic area (MeSH)
Pain, Postoperative
Anatomical therapeutic chemical (ATC) code
N01AH03

Pharmacotherapeutic group

Anesthetics

Therapeutic indication

Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.

Authorisation details

EMA product number
EMEA/H/C/002784
Marketing authorisation holder
FGK Representative Service GmbH

Heimeranstrasse 35
80338 Munich
Germany

Opinion adopted
23/07/2015
Marketing authorisation issued
18/09/2015
Revision
7

Assessment history

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

English (EN) (706.73 KB - PDF)

First published: Last updated:
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Zalviso-H-C-PSUSA-00002798-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

AdoptedReference Number: EMA/425728/2019

English (EN) (657.2 KB - PDF)

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Zalviso : EPAR - Public assessment report

AdoptedReference Number: EMA/612007/2015

English (EN) (4.53 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Zalviso

AdoptedReference Number: EMA/CHMP/471000/2015

English (EN) (642.12 KB - PDF)

First published: Last updated:
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