Suboxone

Withdrawn

This medicine's authorisation has been withdrawn

buprenorphine / naloxone

Overview

On 11 September 2026, the European Commission withdrew the marketing authorisation for Suboxone (buprenorphine / naloxone) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Indivior Europe Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Suboxone was granted marketing authorisation in the EU on 26 September 2006 for the substitution treatment of opioid drug dependence, within a framework of medical, social and psychological treatment. Suboxone was used in adults and adolescents over 15 years of age who had agreed to be treated for addiction.

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2011.

Several therapeutic alternatives remain available, as either buprenorphine alone or buprenorphine in combination with naloxone, in different pharmaceutical forms.

Suboxone : EPAR - Medicine overview

Reference Number: EMA/305684/2020

Suboxone : EPAR - Risk management plan

Product information

Suboxone : EPAR - Product Information

Suboxone : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Suboxone
• Active substance:
  • buprenorphine
  • naloxone
• International non-proprietary name (INN) or common name:
  • buprenorphine
  • naloxone
• Therapeutic area (MeSH):
  Opioid-Related Disorders
• Anatomical therapeutic chemical (ATC) code:
  N07BC51

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000697
• Marketing authorisation holder:
  Indivior Europe Limited

  27 Windsor Place; Dublin 2; Ireland

• Opinion adopted:
  27/07/2006
• Marketing authorisation issued:
  26/09/2006
• Withdrawal of marketing authorisation:
  11/09/2026
• Revision:
  24

Assessment history

Changes since initial authorisation of medicine

Suboxone-H-C-PSUSA-00002113-202309 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/243985/2024

Suboxone : EPAR - Procedural steps taken and scientific information after authorisation

Suboxone-H-C-697-X-0042 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/302500/2020

CHMP post-authorisation summary of positive opinion for Suboxone (X-42)

Adopted Reference Number: EMA/CHMP/219873/2020

Suboxone-H-C-697-X-0029 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/774165/2015

Initial marketing authorisation documents

Suboxone : EPAR - Procedural steps taken before authorisation

Suboxone : EPAR - Scientific Discussion