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
|Agency product number||
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|Anatomical therapeutic chemical (ATC) code||
Accord Healthcare S.L.U.
|Date of issue of marketing authorisation valid throughout the European Union||
World Trade Center
27/07/2022 Zubsolv - EMEA/H/C/004407 - R/0019
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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.