Dzuveo

RSS

sufentanil

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/10/2022

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
5
Date of issue of marketing authorisation valid throughout the European Union
25/06/2018
Contact address

Laboratoire Aguettant
1, rue Alexander Fleming
69007 Lyon
FRANCE

Product information

14/10/2022 Dzuveo - EMEA/H/C/004335 - PSUSA/00002798/202111

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Product information documents contain:

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.

Assessment history

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