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 29/07/2022

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
Accord Healthcare S.L.U.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

27/07/2022 Zubsolv - EMEA/H/C/004407 - R/0019

Product information documents contain:

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.

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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