Suboxone

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 Suboxone. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Suboxone.

This EPAR was last updated on 05/07/2018

Authorisation details

Product details
Name
Suboxone
Agency product number
EMEA/H/C/000697
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
Publication details
Marketing-authorisation holder
Indivior Europe Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
26/09/2006
Contact address
27 Windsor Place
Dublin 2
Ireland

Product information

31/05/2018 Suboxone - EMEA/H/C/000697 - T/0038

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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