Dzuveo

RSS

sufentanil

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

Overview

An overview of Dzuveo and why it is authorised in the EU

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 18/07/2018

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
FGK Representative Service GmbH
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
25/06/2018
Contact address
Heimeranstr. 35
80339 Muenchen
Germany

Product information

25/06/2018 Dzuveo - EMEA/H/C/004335 -

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANESTHETICS

Therapeutic indication

Management of acute moderate to severe pain.

Assessment history

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