buprenorphine / naloxone

This medicine is authorised for use in the European Union.


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 10/10/2023

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

05/10/2023 Zubsolv - EMEA/H/C/004407 - IAIN/0023

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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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