Zalviso
sufentanil
Table of contents
Overview
The marketing authorisation for Zalviso has been withdrawn at the request of the marketing authorisation holder.
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List item
Zalviso : EPAR - Summary for the public (PDF/663.58 KB)
First published: 02/10/2015
Last updated: 27/09/2022 -
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List item
Zalviso : EPAR - Risk-management-plan summary (PDF/656.57 KB)
First published: 02/10/2015
Last updated: 27/09/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Zalviso
|
| Agency product number |
EMEA/H/C/002784
|
| Active substance |
sufentanil
|
| International non-proprietary name (INN) or common name |
sufentanil
|
| Therapeutic area (MeSH) |
Pain, Postoperative
|
| Anatomical therapeutic chemical (ATC) code |
N01AH03
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
FGK Representative Service GmbH
|
| Revision |
7
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/09/2015
|
| Contact address |
Heimeranstrasse 35 |
Product information
05/08/2022 Zalviso - EMEA/H/C/002784 - T/0017
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Anesthetics
Therapeutic indication
Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.