Dzuveo

sufentanil

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About

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.

How is Dzuveo used?

Dzuveo is available as 30 µg sublingual tablets. Using a disposable applicator, the healthcare professional should place one tablet under the patient’s tongue and leave it to dissolve. The tablet must not be chewed or swallowed.

Patients should not eat or drink and should talk as little as possible for the 10 minutes after taking the tablet. They can be given the tablets as needed but should wait at least one hour after one tablet before having another. Dzuveo should not be used for more than 48 hours.

Dzuveo can only be obtained with a prescription. It should be given by a healthcare professional experienced in treating pain and in a place (such as a hospital) where the patient can be monitored. For more information about using Dzuveo, see the package leaflet or contact your doctor or pharmacist.

How does Dzuveo work?

The active substance in Dzuveo, sufentanil, is an opioid that works by attaching to receptors (targets) in the brain known as μ-opioid receptors. Attaching to these receptors in the brain helps relieve the patient’s pain.

 

What benefits of Dzuveo have been shown in studies?

Two main studies have shown that Dzuveo left to dissolve under the tongue is effective at reducing severe pain following surgeries. Both studies used a pain rating scale known as SPID12 which tracks reduction in pain over 12 hours.

In the first study in 163 patients who had undergone abdominal surgery, pain reduced by 26 points with Dzuveo compared with 13 points with placebo (a dummy treatment). In the second study in 101 patients after foot surgery, pain reduced by around 6 points with Dzuveo and increased by around 7 points with placebo.

What are the risks associated with Dzuveo?

The most serious side effects with sufentanil are severe breathing problems, which occur in around 6 people in 1,000. The most common side effects (which may affect more than 1 in 10 people) are nausea, vomiting and fever.

Dzuveo must not be used in patients with serious lung or breathing problems. For the full list of side effects and restrictions with Dzuveo, see the package leaflet.

Why is Dzuveo authorised in the EU?

Studies show that Dzuveo is effective at reducing severe pain following surgeries. The side effects seen with Dzuveo are those expected with opioids, and are considered manageable. The European Medicines Agency therefore decided that Dzuveo’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Dzuveo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dzuveo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Dzuveo are continuously monitored. Side effects reported with Dzuveo are carefully evaluated and any necessary action taken to protect patients.

Other information about Dzuveo

Dzuveo received a marketing authorisation valid throughout the EU on 25 June 2018.

Name Language First published Last updated
Dzuveo : EPAR - Summary for the public BG = bălgarski 2018-07-18  
Dzuveo : EPAR - Summary for the public ES = español 2018-07-18  
Dzuveo : EPAR - Summary for the public CS = čeština 2018-07-18  
Dzuveo : EPAR - Summary for the public DA = dansk 2018-07-18  
Dzuveo : EPAR - Summary for the public DE = Deutsch 2018-07-18  
Dzuveo : EPAR - Summary for the public ET = eesti keel 2018-07-18  
Dzuveo : EPAR - Summary for the public EL = elliniká 2018-07-18  
Dzuveo : EPAR - Summary for the public EN = English 2018-07-18  
Dzuveo : EPAR - Summary for the public FR = français 2018-07-18  
Dzuveo : EPAR - Summary for the public IT = italiano 2018-07-18  
Dzuveo : EPAR - Summary for the public LV = latviešu valoda 2018-07-18  
Dzuveo : EPAR - Summary for the public LT = lietuvių kalba 2018-07-18  
Dzuveo : EPAR - Summary for the public HU = magyar 2018-07-18  
Dzuveo : EPAR - Summary for the public MT = Malti 2018-07-18  
Dzuveo : EPAR - Summary for the public NL = Nederlands 2018-07-18  
Dzuveo : EPAR - Summary for the public PL = polski 2018-07-18  
Dzuveo : EPAR - Summary for the public PT = português 2018-07-18  
Dzuveo : EPAR - Summary for the public RO = română 2018-07-18  
Dzuveo : EPAR - Summary for the public SK = slovenčina 2018-07-18  
Dzuveo : EPAR - Summary for the public SL = slovenščina 2018-07-18  
Dzuveo : EPAR - Summary for the public FI = suomi 2018-07-18  
Dzuveo : EPAR - Summary for the public SV = svenska 2018-07-18  
Dzuveo : EPAR - Summary for the public HR = Hrvatski 2018-07-18  
Name Language First published Last updated
Dzuveo : EPAR - Risk-management-plan summary (English only) 2018-07-18  

This EPAR was last updated on 18/07/2018 .

Authorisation details

Product details

Product details for Dzuveo
NameDzuveo
Agency product numberEMEA/H/C/004335
Active substance

sufentanil citrate

International non-proprietary name (INN) or common name

sufentanil

Therapeutic area Pain
Anatomical therapeutic chemical (ATC) code N01AH03

Publication details

Publication details for Dzuveo
Marketing-authorisation holder

FGK Representative Service GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union25/06/2018

Contact address:

FGK Representative Service GmbH
Heimeranstr. 35
80339 Muenchen
Germany

Product information

Product information

25/06/2018  Dzuveo -EMEA/H/C/004335

Name Language First published Last updated
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  
Dzuveo : EPAR - Product Information EN = English 2018-07-18  

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.


Name Language First published Last updated
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  
Dzuveo : EPAR - All Authorised presentations EN = English 2018-07-18  

Pharmacotherapeutic group

Anesthetics

Therapeutic indication

Management of acute moderate to severe pain.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Dzuveo : EPAR - Public assessment report EN = English 2018-07-18  
CHMP summary of positive opinion for Dzuveo EN = English 2018-04-27  

Authorised

This medicine is approved for use in the European Union