buprenorphine / naloxone
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.
Suboxone : EPAR - Medicine overview (PDF/114.64 KB)
First published: 19/10/2006
Last updated: 28/07/2020
Suboxone : EPAR - Risk-management-plan summary (PDF/59.79 KB)
First published: 28/07/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Indivior Europe Limited
|Date of issue of marketing authorisation valid throughout the European Union||
27 Windsor Place
30/08/2021 Suboxone - EMEA/H/C/000697 - IB/0052
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Other nervous system drugs
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.