Overview

The marketing authorisation for Zalviso has been withdrawn at the request of the marketing authorisation holder.

Zalviso : EPAR - Summary for the public

English (EN) (663.58 KB - PDF)

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български (BG) (760.64 KB - PDF)

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español (ES) (667.71 KB - PDF)

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čeština (CS) (739.15 KB - PDF)

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dansk (DA) (665.9 KB - PDF)

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Deutsch (DE) (670.41 KB - PDF)

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eesti keel (ET) (665.35 KB - PDF)

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ελληνικά (EL) (762.93 KB - PDF)

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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)

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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)

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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.
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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).

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
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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
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latviešu valoda (LV) (622.41 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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lietuvių kalba (LT) (605.38 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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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
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norsk (NO) (589.15 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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polski (PL) (620.57 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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português (PT) (589.37 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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română (RO) (606.42 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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slovenčina (SK) (619.68 KB - PDF)

First published: 02/10/2015Last updated: 27/09/2022
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slovenščina (SL) (618.15 KB - PDF)

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

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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)

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CHMP summary of positive opinion for Zalviso

AdoptedReference Number: EMA/CHMP/471000/2015

English (EN) (642.12 KB - PDF)

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More information on Zalviso

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

Reference Number: EMA/670718/2022

English (EN) (124.46 KB - PDF)

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