buprenorphine / naloxone
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.
Zubsolv : EPAR - Summary for the public (PDF/76.55 KB)
First published: 12/01/2018
Last updated: 12/01/2018
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22/12/2020 Zubsolv - EMEA/H/C/004407 - IB/0011
- 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.
Other nervous system drugs
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.