This is a summary of the European public assessment report (EPAR) for Zalviso. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zalviso.
For practical information about using Zalviso, patients should read the package leaflet or contact their doctor or pharmacist.
Zalviso : EPAR - Summary for the public (PDF/77.05 KB)
First published: 02/10/2015
Last updated: 02/10/2015
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01/10/2019 Zalviso - EMEA/H/C/002784 - PSUSA/00002798/201811
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.