Suboxone

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buprenorphine / naloxone

Authorised
This medicine is authorised for use in the European Union.

Overview

Suboxone is a medicine to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support.

Suboxone is contains two active substances, buprenorphine and naloxone.

This EPAR was last updated on 21/02/2022

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
20
Date of issue of marketing authorisation valid throughout the European Union
26/09/2006
Contact address
27 Windsor Place
Dublin 2
Ireland

Product information

30/08/2021 Suboxone - EMEA/H/C/000697 - IB/0052

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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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