Zubsolv

RSS

buprenorphine / naloxone

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

Overview

This is a summary of the European public assessment report (EPAR) for Zubsolv. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zubsolv.

For practical information about using Zubsolv, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/03/2018

Authorisation details

Product details
Name
Zubsolv
Agency product number
EMEA/H/C/004407
Active substance
buprenorphine hydrochloride, naloxone hydrochloride dihydrate
International non-proprietary name (INN) or common name
buprenorphine / naloxone
Therapeutic area (MeSH)
Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code
N07BC51
Publication details
Marketing-authorisation holder
Mundipharma Corporation Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address
Milton Road
Cambridge Science Park
Cambridge CB4 0AB
United Kingdom

Product information

02/02/2018 Zubsolv - EMEA/H/C/004407 - IB/0001/G

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

OTHER NERVOUS SYSTEM DRUGS

Therapeutic indication

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.

The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

Assessment history

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