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EMA Product

Zubsolv

Product approved by European Medicines Agency (EU)

Basic Information

Zubsolv

Regulatory Information

EMEA/H/C/004407

Authorised

November 10, 2017

13

April 1, 2025

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Active Substances Detail

Buprenorphine hydrochlorideNaloxone hydrochloride dihydrate

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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