Dzuveo
sufentanil
Table of contents
Overview
Dzuveo is an opioid pain medicine used to treat moderate to severe pain in adults.
It is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ (called Sufenta Forte) containing the same active substance. The difference between the products is that Dzuveo is available as sublingual tablets (tablets to be dissolved under the tongue) while the reference medicine is a solution for injection.
Dzuveo contains the active substance sufentanil.
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List item
Dzuveo : EPAR - Summary for the public (PDF/82.96 KB)
First published: 18/07/2018
Last updated: 18/07/2018
EMA/283761/2018 -
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List item
Dzuveo : EPAR - Risk-management-plan summary (PDF/133.5 KB)
First published: 18/07/2018
Last updated: 31/03/2023
Authorisation details
Product details | |
---|---|
Name |
Dzuveo
|
Agency product number |
EMEA/H/C/004335
|
Active substance |
sufentanil citrate
|
International non-proprietary name (INN) or common name |
sufentanil
|
Therapeutic area (MeSH) |
Pain
|
Anatomical therapeutic chemical (ATC) code |
N01AH03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Laboratoire Aguettant
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
25/06/2018
|
Contact address |
Laboratoire Aguettant |
Product information
24/03/2023 Dzuveo - EMEA/H/C/004335 - R/0009
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
Dzuveo is indicated for the management of acute moderate to severe pain in adult patients.